Cofepris | Mexico | Regulatory | global regulatory partners

Medical Devices

Mexico’s Regulatory Health Authority:

Medical Devices are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). All medical devices imported into or distributed within Mexico must first undergo registration with COFEPRIS.

Cofepris Medial Device Definition:

“a the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its appropriate use or application), used alone or in combination for the diagnosis, monitoring or prevention of diseases in humans or in the treatment of the same and of the disability, as well as those used in the replacement, correction, restoration or modification of the anatomy or human physiological processes.”

Medical Device Registration in Mexico:

Registering a device or IVD in Mexico can be extremely difficult for non-Spanish speakers. COFEPRIS, the regulatory authority that oversees medical device and IVD registration , provides  very limited information  on their website in English, furthermore, they require all documentation and communication to take place in Spanish. GRP office located in Mexico City has a team of bilingual regulatory experts that can help you access Mexico’s medical device market.

More Resources:

Authorized local agent

Mexican Health Authority (COFEPRIS) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. In Mexico, GRP Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.

GRP-Mexico Local Agent Services:

  • Communication with COFEPRIS
  • Product Registration
  • Assistance with COFEPRIS inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support COFEPRIS consultation meetings.
  • Recall or incident report assistance 
Mexico's Cofepris releases provision for ventilator requirements during COVID-19
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Mexico.

Regulatory Strategy

Registering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS. However, registering a device or IVD in Mexico can be challenging. Little information on the registration process is available in English from COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) responsible for medical device and IVD oversight.

GRP’s consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.

GRP Regulatory Strategy Services (Mexico):

  • GRP can determine the proper classification for your medical device and can provide an initial assessment on grouping acceptability, if necessary.
  • Many manufacturers work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
  • Our in-depth knowledge of the Mexican medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
  • We can assist you in preparing medical device registration documents that demonstrate compliance with COFEPRIS.
  • Our Mexico Registration Holder services allow us to submit devices for COFEPRIS approval on your behalf.
Regulatory Affairs | Global Regulatory Partners

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration.  Our Regulatory affair’s team helps medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements of COFEPRIS in order to successfully register and commercialize their products in the Mexican market and maximize the value of their assets.

Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory operations, and publishing
  • Product registration
  • Registration amendments
  • Consulting meetings with regulatory authorities

Product registration

COFEPRIS classifies medical devices into four categories based on risk to the patient. Table 1 summarizes the 4 Device Classes and their associated risk description. Table 2 summarizes various registration pathways for Medical Devices.

TABLE 1: MEDICAL DEVICES CLASSIFICATION

Device Class Description
Class I Lowest Risk
Class IA Low Risk
Class II Medium Risk
Class III Devices High Risk

Table 2: MEDICAL DEVICE Registration Pathway

Registration Pathway Description Application Requirements
Equivalency Review Process If your device has been approved in the US, Canada or Japan, you may qualify for an equivalency review

Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process
US, Canada Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements – Product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling with instructions for use.
Japan Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements • Notification of Exportation • Original Certificate of Free Sale with codes; no older than one year • Certification issued by the Registered Certification Body or MHLW: – Description – Indications for use – Formula and/or composition, if applicable – Stability information, if applicable – Sterility period, if applicable – Primary and secondary packaging information, if applicable – Compliant labeling, instructions for use.
Standard Review to register through the standard review process, you must prepare a detailed Registration Dossier that includes full product technical information and applicable testing results.

Applications going through the standard review process are also eligible for Third Party Review, which has the potential to expedite the approval process, and incurs additional cost to pay for the third-party reviewer.
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof of home country approval – Detailed product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for use
Class IA Low risk device registration Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Compliant labeling, instructions for use.

GRP-Mexico IVD/Device Registration Services:

  • Act as your Mexico Registration Holder
  • Determine classification of your medical device or IVD
  • Help you determine the proper regulatory pathway for your devices
  • Inform you of the documentation required within the applicable registration route.
  • Help you determine a grouping strategy for your registration
  • Prepare and submit registration application documents to COFEPRIS
  • Coordinate translation of submission materials into Spanish
  • Work to answer questions from COFEPRIS during the submission process

Medical writing

Medical writing | Global Regulatory Partners

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules

Health authority consultation

Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan. Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with COFEPRIS heath authorities before starting key milestone of your product development.

GRP Regulatory Affairs  Support Team Services:

  • Prepare and submit of the meeting package to the health authority
  • Prepare the questions to health authority based on the status of your product’s development and future plan
  • Provide support during the meeting
  • Write the meeting minutes and develop the appropriate action plan after the consultation meeting.  
meeting | health authority

Clinical Trials

Clinical Trials in Mexico are known as Ensayos Clínicos. Clinical trials authorizations with the purpose of registering a pharmaceutical product are requested based on the type of research, the origin of the product or the research procedure. Applicants may submit the documents to gain authorization to perform Clinical Trials/Human Subjects Research Protocol directly to Cofepris or request a preliminary evaluation report to a UHAP (support units enabled to emit preliminary report).

UHAP Evaluations:

UHAP evaluations are voluntary. Contact method and costs are not standardized among UHAPs. The preliminary report attached to the file submitted to Cofepris may speed up the processing process. Applications including UHAP reports may be issued in up to 30 business days.

Figure 1: Clinical Trial Application Process:

Figure 2: Clinical Trial Protocol Authorization Process

Table 1: Submission Material

Module

Included Documents

I

  • Application Form and/or Escrito Libre (Detailed Cover Letter with Product Specifications)

II

  • Proof of payment – Original and 2 copies

III

  • Letter accepting research involvement and responsibilities of researcher(s)/sponsor(s) expressing also prevention measures of conflict of interests, especially if there is monetary compensation involved.
  • Letter issued by the CRO/sponsor describing the human resources and materials to be destined in the research in all research sites.
  • Letter from the sponsor with a monitoring/auditing plan

IV

  • Research Protocol
  • Informed Consent Letters
  • Timeframe/Schedule

V

  • Ethics Committee Certificate (Copy)
  • Research Committee Certificate (Copy)
  • Research and Ethics Committee Approval Report
  • Research Committee Approval Report

VI

  • Other requested by current health regulations in the field of research for human health

GRP Clinical Trial Services (Mexico):

  • Clinical Trial Consulting Services

    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.

  • Regulatory Support

    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate  regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.

  • Clinical Trials Management

    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.

  • Quality Compliance and Audits

    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.

  • Adverse Events and Post Market Surveillance

    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Research Protocol Forms

COFEPRIS 04-010 A: Pharmaceutical Products (Biologics and Biotechnological) Cost: $ 5,880 MXN

COFEPRIS 04-010 B: Pharmaceutical Products (Bioequivalence Studies) Cost: $5,880 MXN

COFEPRIS 04-010 C: New Resources (Materials, grafts, transplants, prostheses, physical, chemical procedures and other methods of prevention, diagnosis and treatment) Cost: $5,880 MXN

COFEPRIS 04-010 D: Risk-free Research (Observational studies that employ techniques, methods of  documentary research and those in which no intervention or intentional  modification is made in the physiological, psychological and social variables of the  research subjects) Cost: $5,880 MXN

Registration Timelines:

Requests submitted directly to Cofepris, for any Research Protocol (clinical trials) unless having preliminary report from a UHAP, are taking an estimate of 90 business days for processing.

Quality

Implementing and maintaining a quality management system (QMS)

Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance for most markets worldwide. For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls. Pre-production QMS for eventual compliance with FDA QSR and ISO 13485.

While a quality system typically does not have to be fully implemented until you begin your medical device registration, implementing an initial partial QMS system can make implementing a full QMS less burdensome, and may shorten your time to commercialization in the long run.

Pre-Production QMS:

A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution.  The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.

 

Compliance with design control procedures.

The US Food and Drug Administration (FDA) and other market regulators including COFEPRIS require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.

To ensure ongoing compliance with quality system procedures, you should;

  • evaluate your pre-production QMS using internal audits at least once a year.
  •   Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.

 

GRP QMS implementation Services:

  • Document and records control
  • Training on regulatory requirements and internal procedures
  • Design and development
  • Risk management
  • Software development (if applicable)
  • Supplier evaluation
  • Control of measurement equipment
  • Perform internal quality system audits

GRP Extensive Quality Experience:

GRP has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements including COFEPRIS . Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering. We can also perform internal quality system audits if you do not have the staff or resources to do so.

Pharmaceuticals

Mexico’s Health Authority:

Pharmaceuticals in Mexico are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). 

Cofepris Drug Definition:

According to Article 221, Section I of the General Health Law a drug is defines as;

“Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect, that is presented in a pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics. When a product contains nutrients, it will be considered a medicine, as long as it is a preparation that contains individually or in association: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher than those of natural foods and it is also present in some defined pharmaceutical form and the indication of use contemplates therapeutic, preventive or rehabilitative effects.”

New Molecule Definition:

“Active Principle of a medication, of natural or syntetic origin, not previously used in the country and whose efficacy, safety and therapeutic purposes have not yet been completely reported in the scientific literature.

GRP Pharmaceutical Services:

Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

More Resources:

Authorized local agent

Mexican Health Authority (COFEPRIS ) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. 

GRP- Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.

GRP-Mexico Local Agent Services:

  • Communication with COFEPRIS
  • Product Registration
  • Assistance with COFEPRIS inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support COFEPRIS consultation meetings.
  • Recall or incident report assistance 
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Mexico’s Pharmaceutical Industry:

In Latin America, Mexico’s pharmaceutical industry comes in second after Brazil. In 2017, the country’s pharmaceutical industry reached a revenue of nearly 150 billion Mexican pesos, or approximately 7.6 billion U.S. dollars.

Mexico has signed a total of 12 FTAs with 33 countries, including Japan, the European Union, the United States (US), Canada and Israel as well is a member of the North American Free Trade Agreement (NAFTA). 

GRP RI Services:

At Global Regulatory Partners,  our team of professionals in Mexico can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular needs in Mexico.

Regulatory Strategy

Registering your product for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS.

Registering a product in Mexico can be challenging process.  GRP’s consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.

GRP Regulatory Strategy Services ( Mexico):

  •  Determine the proper classification for your product and can provide an initial assessment, if necessary.
  • Work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
  • Provide the most efficient and cost-effective regulatory approval strategy for your device.
  • Assist you in preparing registration documents that demonstrate compliance with COFEPRIS.
  • Submit device registration to COFEPRIS for approval.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP Inc. regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product registration, products’ life cycle management and maintenance.

GRP Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Operations and Publishing
  • Product Registration
  • Products’ life cycle management and maintenance.
Regulatory Affairs | Global Regulatory Partners

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Mexico. GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of COFEPRIS eCTD requirements.

GRP Compliance:

GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

GRP Regulatory Operation Services:

  • consulting services
  • planning and assembly of submissions
  • document creation and approval
  • e-Submission
  • roadmap compliance,
  • publishing,
  • viewing and navigation
  • archiving
  • submission process optimization
  • tracking and lifecycle management.

Product registration

Figure 1: Registration Pathways of Pharmaceuticals in Mexico

Table 1: MEDICAL DEVICE Registration Pathway

Registration Pathway Description Application Requirements Timelines
Equivalency Review Process If your device has been approved in the US, Canada or Japan, you may qualify for an equivalency review

Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process
US, Canada Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements – Product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling with instructions for use.
APPLICATION

US
3-8 months

CANADA
3-8 months
——
VALIDITY PERIOD
5 Years
Japan Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements • Notification of Exportation • Original Certificate of Free Sale with codes; no older than one year • Certification issued by the Registered Certification Body or MHLW: – Description – Indications for use – Formula and/or composition, if applicable – Stability information, if applicable – Sterility period, if applicable – Primary and secondary packaging information, if applicable – Compliant labeling, instructions for use.
APPLICATION

Japan
3-8 months
——
VALIDITY PERIOD
5 Years
Standard Review to register through the standard review process, you must prepare a detailed Registration Dossier that includes full product technical information and applicable testing results.

Applications going through the standard review process are also eligible for Third Party Review, which has the potential to expedite the approval process, and incurs additional cost to pay for the third-party reviewer.
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof of home country approval – Detailed product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for use APPLICATION

Standard Review
3-6 months
——
VALIDITY PERIOD
5 Years
Class I Lowest risk device registration Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Compliant labeling, instructions for use. APPLICATION
1-3 months
Registration Renewal Should be started 12 months in advanced}. (applies for all categories)

Application Process:

The formal application process starts when a pharmaceutical company takes the compilation of documents known as the application dossier to the COFEPRIS office.

Deficiency Letters:

The reviewers at the COFEPRIS will read everything very thoroughly and will address any question they might have about the data on the dossier in the form of a letter, commonly called deficiency letter, officially called prevención in Mexico. Deficiency letters are not always issued, and most of them can be avoided by following all the guidelines, submitting complete information, and avoiding common silly mistakes.

 

Market Authorization (MA) Timeline:

The marketing authorization is granted for a period of five years. Submission for registration renewal must be filed at least 6 months before expiry.

“NEw Molecule”

If your product falls into the category of ‘new molecule’, you have to request a meeting with the New Molecule Committee before submitting the application.

Cases Considered as a “New Molecule”

  1. New drug substances (new in the world or new for Mexico)
  2. New combinations of drug substances (for Mexico)
  3. New indications
  4. Other special cases (e.g. similar biotherapeutic products)

Up until recently, the average application could take anything between 1 and 4 years to be reviewed and approved. With some key changes implemented lately, such as the pre-revision process by Third Authorized Parties, or the Agreement for Innovation, timelines are decreasing dramatically, to just some months to a year.

GRP Product Registration Services:

  • Act as your Mexico Registration Holder
  • Determine classification of your pharmaceutical product
  • Help you determine the proper regulatory pathway for your product
  • Inform you of the documentation required within the applicable registration route.
  • Help you determine a grouping strategy for your registration
  • Prepare and submit registration application documents to COFEPRIS
  • Coordinate translation of submission materials into Spanish
  • Work to answer questions from COFEPRIS during the submission process

Quality

The Directorate for the Evaluation of Processes for the Pharmaceutical/Chemical Industry (DEPIQF) of the COFEPRIS is responsible for regulating the establishments dedicated to the manufacture of medicinal products. The Directorate also regulates medicinal products classified as controlled substances for the evaluation of medicinal products of the COFEPRIS.

COFEPRIS conducts GMP verification:

The GMP certificate is issued to each manufacturing site in compliance with GMP, after inspection of the relevant authority. The certificate is the only document that states the GMP compliance and is valid only for the time indicated on the certificate. A valid GMP certificate should be submitted to the regulatory authority when the applicant submits a request for a new product registration, to renew or modify an existing one.

  • For new registration and manufacturing changes of biologic, biotech and hemo-derivate products.
  • For new registration or renewal of drug products or drug substances of any kind manufactured in countries not considered as high sanitary surveillance by COFEPRIS.
  • Drug product and Drug substance manufacturing sites are inspected.

Equivalent GMP Certificates:

The following GMP Certificates are accepted by Cofepris.

  • FDA (USA)
  • ANVISA (Brazil)
  • Health Canada (Canada)
  • EMA (EU)
  • Pharmaceutical and Food Safety Bureau (Japan),
  • Therapeutic Goods Administration (Australia)

GMP certificates issued by the authorities of the countries mentioned above must be accredited or notarized copies, and must be with a statement confirming that the certificate is authentic and was issued in accordance with related laws and regulations in Mexico.

GMP requirements for API manufacturers:

Manufacturers of active pharmaceutical ingredients (APIs) for medicinal products and clinical investigations have to comply with the Official Mexican Norm NOM-164-SSA1-2015. 

The content of an API GMP file is very similar to the Drug Master File (DMF). The content of the Manufacturing Site Master Records is fully described in NOM-164-SSA1-2015.

Inspection request submission Material:

  • Submit form and required documents
  • Propose two inspection dates (production of DS/DP) and inspection schedule
  • Propose hotel and flight options. Cost of visit + travel expenses: company
  • Arrange a Spanish translator
  • Timeline to get an inspection: about 3 months

GRP-Mexico Quality services:

  • Assist you for GMP compliance per Mexican Requisites.
  • Audits
  • Inspection is necessary before submission of the dossier.

Clinical

Regulation:

The primary legislation for conducting clinical trials in Mexico is the Health Law Regulations for Health Research (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud) (RLGSMIS) and the NOM for Health Research in Human Beings.

Cofepris | Mexico | Regulatory | global regulatory partners

figure 1: Clinical Trial Application Process

Figure 2: Clinical Trial Protocol Approval Process in Mexico

GRP’s Clinical Trial Services (Mexico):

  • Clinical Trial Consulting Services

    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support

    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management

    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits

    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance

    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Local clinical studies required by COFEPRIS:

  • New molecules
  • Biotech and biocomparable products
  • Generic drugs that are not commercialized anywhere else in the world.
  • Other cases upon authority request

Pharmacovigilance Studies on Mexican Hispanic Populations:

Pharmacogenomic studies have shown that drug metabolism in Mexican-Hispanic population can be influenced by its genetic makeup. 

When clinical studies are multicentric, Mexican population must be included. If Mexican patients are not included in the clinical trials: New Molecule Committee will request pharmacokinetic studies to evidence not significant differences in safety or efficacy in Mexicans.

Research Protocol Forms

COFEPRIS 04-010 A: Pharmaceutical Products (Biologics and Biotechnological) Cost: $ 5,880 MXN

COFEPRIS 04-010 B: Pharmaceutical Products (Bioequivalence Studies) Cost: $5,880 MXN

COFEPRIS 04-010 C: New Resources (Materials, grafts, transplants, prostheses, physical, chemical procedures and other methods of prevention, diagnosis and treatment) Cost: $5,880 MXN

COFEPRIS 04-010 D: Risk-free Research (Observational studies that employ techniques, methods of  documentary research and those in which no intervention or intentional  modification is made in the physiological, psychological and social variables of the  research subjects) Cost: $5,880 MXN

GRP Clinical Trial Expertise in Mexico:

An understanding of the regulatory requirements in Mexico and experience in dealing with the local regulatory authorities (Cofepris) is essential in administering a smooth, successful clinical trial in Mexico. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Mexico. Our local teams and affiliated partners located in Mexico and all-around LATAM are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

Cosmetics

Mexico’s Regulatory Health Authority:

Cosmetics are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). 

Cofepris Cosmetic Definition

In Mexico, cosmetics are defined as “Products intended to be brought into contact with the parts of the human body to clean, perfume, help and with the principal purpose of cleaning, perfuming, helping to modify their appearance, protecting, keeping in good condition, correcting body odors or reducing alterations in the functioning of healthy skin.”

GRP Cosmetic Services:

Global Regulatory Partners Inc. (GRP) office in Mexico City provides end-to-end regulatory affairs services for cosmetics that include: regulatory intelligence, regulatory strategy, product classification, formulation review, claim assessments and labeling assessment in compliance with COFEPRIS requirements.  

Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing strategic advice concerning product classification from products’ development till commercialization.

More Resources:

Authorized local agent

Global Regulatory Partners Inc. (GRP) has local offices in Mexico and is licensed by the COFEPRIS to act as your authorized local agent for your Cosmetic and Personal Care Products. GRP- Mexico team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP-Mexico helps manufacturers, distributors, and marketers of cosmetics in Mexico.

GRP -Mexico Cosmetic Services:

  • Authorized local Agent
  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory intelligence

Mexico’s cosmetic Regulatory history:

In 2015, Mexico’s FDA equivalent, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), updated regulatory standards that apply to cosmetics, perfumes, and personal care products. The objective was to harmonize Mexican requirements for cosmetics and personal care products with international standards to facilitate trade.  The new regulations modify two standards, NOM 159 and NOM 259, which describe requirements for best practices in production, labeling, and packaging for cosmetics and personal care products, as well as the list of permitted substances used in the manufacture of cosmetics and perfumes.

Market Overview:

According to the Brazilian Association of Personal Hygiene, Perfumery and Cosmetics Industry, Latin America accounts for 14.1 percent of the world market and Mexico, being the second-largest market in Latin America, had a value of 10 billion dollars in 2018 and  is forecast to reach a value of 10,649.8 million dollars by 2022.

Current cosmetic Trends in Mexico:

Current Trends in Mexico include the growing beauty consciousness among the male consumers which is seen with the increase in the number of brands foraying into internet retailing. In Mexico this segment is expected to grow at rates of over 10 percent through 2023 due to the positive image that mainstream media and hipster trends have helped create among younger generations.

Changes to consumer lifestyle has also affected cosmetics as their is an increase in women employees at the workplace are expected to heavily impact the consumption of beauty and personal grooming products in Mexico. 

GRP RI Cosmetic Services:

Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP-Mexico team of experts can collect the following regulatory and  requirements applicable to your product entry into Mexico’s Market such as: 

  • Registration dossier
  • Claims
  • Prohibited list of ingredients
  • Importation regulations
  • Specification of ingredients 
  • Labeling requirements

Regulatory Strategy

Cosmetic Regulatory Strategy in Mexico:

Developing the right regulatory strategy for your products in Mexico is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products in the Mexican market.

Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as;

  • Information on your products and similar products on the market
  • Product development status and milestones
  •  Business goals and timelines
  • The regulatory requirements related to your product,cost, and risk assessment

With a global presence and a local team of experts, GRP-Mexico regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Affairs

Global Regulatory Partner MX provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include:

  • regulatory intelligence
  • regulatory strategy
  • regulatory operations
  • and publishing
  • product registration
  • registration amendments;
  • consulting meetings with COFEPRIS regulatory authorities.

Our Regulatory affairs teams in Mexico help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in the Mexican market and maximize the value of their assets.

Company Registration with Cofepris:

In Mexico, a cosmetic company must register with the SSA (Secretariat of Health) for a physical and chemical analysis, complete with a Spanish translation and / or a free sale certificate and consular legalization. The Ministry has laid down a fixed set of requirements and recommendations to ensure that each product enters the market meeting regulatory standards, providing that cosmetic companies follow the new labeling procedures stringently.  This standard is mandatory in the national territory to persons or entities ​engaged in the process or importation of cosmetic products.

Product Registration

The Ministry of Health in Mexico, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) standardized the regulation that applies to the cosmetics products industry in order to meet International best practices that compare them with those of developed countries.

With the recent change in the regulations is no longer mandatory to apply for product classification or sanitary license to COFEPRIS for cosmetic products. As the process isn’t as stringent anymore so cosmetics can just be notified to COFEPRIS by including the product in the business license and importation permit application in order to import the product.

Cosmetic packaging and labeling review

The Mexico’s Ministry of Health has published a labeling standard for pre-packaged cosmetics to clear up instances where a product might be misinterpreted or even misbranded.​ The standard PROYNOM141SSA1/SCFI2010 ‘Labeling of pre‑packaged cosmetic products, Health and commercial labeling​,’ is published in the administration’s official journal (Diario Oficial de la Federación​).

The labeling for a cosmetic product should contain :

  • All the labeling content should be in Spanish.
  • Include generic and specific name of the product

  • Include identification of the person responsible for the product.

  • Include the batch number

  • Include the Instructions or mode of use

  • Not include prohibited property statements

  • Comply wit the commercial information as per the provisions of NOM-008-SCFI-2002 General System of Measurement Units

  • Include the sanitary information

GRP Labeling Services:

Global regulatory Partners, Inc., (GRP) provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate region-specific regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with COFEPRIS requirements and cosmetic products can be used safely by Mexican consumers.

Product classification & Formulation Review

Ingredient compliance:

The company must check that the ingredients included in the cosmetic product are not listed in the forbidden or restricted list of ingredients as defined in Articles 234 and 245 of the General Health Law, drugs, prepared drugs and the following may not be used in the preparation of perfume and beauty products.

cosmetics in store

GRP Product Classification and Formulation Review Services:

Global Regulatory Partners Inc. (GRP) provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP-Mexico can review your products and make sure they comply with the COFEPRIS regulations.

Mexico. Aztec temple

Nutraceuticals

Regulatory Health Authority:

The Federal Commission for Protection again health risks (COFEPRIS) is the main body in charge of Nutraceutical regulation in Mexico.

Dietary Supplement Definition:

Article 215 of the General Health Act defines dietary supplements as “herbal products, plant extracts, traditional foods, dehydrated or concentrated fruit added or not, vitamins or minerals that may arise in a pharmaceutical form and intended use is to increase total dietary intake, supplement it or replace some component of one’s diet.

Dietary Supplement Categories: 

There are specific provisions that regulate different types of natural health products, including: Herbal, homeopathic and vitamin medicines, Herbal remedies and Dietary supplements.

Legislative Considerations:

According to Mexican health legislation, dietary supplements cannot be composed solely of vitamins and minerals – in which case they are considered a vitamin drug, not a dietary supplement. Nutritional supplements may also contain substances with pharmacological action (natural or synthetic), for example, saw palmetto (plant), ephedrine, amphetamines, among many others.

GRP Dietary Supplement Services:

Global Regulatory Partners, Inc. (GRP), has a team of experts in Mexico who can help Nutraceutical and food supplements companies in Mexico during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

More Resources:

  • “Read More” -For  more information on Nutraceuticals and GRP’s services in Mexico

Authorized local agent

A marketing authorization issued by the Federal Commission for Protection against Sanitary Risk (COFEPRIS) is required to sell herbal, homeopathic and vitamin medicines manufactured in other jurisdictions. A recordal (clave alfanumérica), a type of approval, with COFEPRIS is required to sell herbal remedies. Selling medicines without a marketing authorization can be prosecuted as a criminal offence.

Global Regulatory Partners, Inc. (GRP), has a team of experts in Mexico who can help Nutraceutical and food supplements companies in Mexico during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by COFEPRIS regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

GRP -Mexico Nutraceutical Services:

  • Authorized local agent
  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, product registration, product formulation and labelling review.

GRP-Mexico team provides support to Nutraceutical companies during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers, reviews and validates the nutrient content claims and health claims before products’ commercialization in Mexico.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

At Global Regulatory Partners Inc. (GRP), our  team of professionals in Mexico can provide you with tailored Regulatory Intelligence that includes the latest COFEPRIS regulatory information and recommendations for the commercialization of your Nutraceuticals in the Mexican market.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in the Mexican market is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for different markets. GRP-Mexico strategy will help you meet your business objectives and goals and reduce your risk of failure.

In developing the regulatory strategy in Mexico, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.

With a global presence and a local team of experts, GRP-Mexico regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.

In addition, the regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.

GRP-Mexico can review your products and make sure they comply with COFEPRIS regulated under Article 215 of the General Health Act

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices.

Global Regulatory Partners Inc. (GRP) team in Mexico has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by COFEPRIS standards. GRP-Mexico can review your products and make sure they comply with Article 215 of the General Health Act.

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