Brazil

Medical Devices

Due to the rise of complex technologies and constant changing of regulatory environment regulatory professionals in the Medical Device Industry are facing more challenges. In addition to keeping up with these changes, regulators must also define the correct pathway for incoming registered products. Global Regulatory Partners Inc. has a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in different markets.

Authorized local agent

Brazilian Health Regulatory Agency (ANVISA) requires that any Foreign medical device company, without a physical location in Brazil, who intends to sell its product in the Federative Republic of Brazil to appoint a Brazilian Registration Holder (BRH).

 GRP-Brazil is licensed by ANVISA to act as your BRH:

  • Control your registrations and your BGMP certification. 
  • Communication with ANVISA 
  • Product Registration
  • Assistance with ANVISA inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support ANVISA consultation meetings.
  • Recall or incident report assistance 
  • Manage Distributors
  • License Renewal                                                

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.

Regulatory Strategy

ANVISA has established essential requirements for compliance similar to those developed in the European Union, and provides two major pathways to device approval: Cadastro (low risk) and Registro (high risk). Cadastro is simpler and faster, but both Cadastro and Registro require formal registration and approval from ANVISA. Some medical devices require Brazilian Good Manufacturing Practice (BGMP) certification, as well.

Global Regulatory Partners can help you determine which of the above processes your device will fall under, as well as any additional requirements that will apply to your device. Additionally, we confirm the overall costs and timeline to market, so that you can pre-assess the requirements. Let Global Regulatory Partners assist you in evaluating the Brazilian medical device regulatory framework as it applies to your device(s)

  • ANVISA Regulatory Background
  • Product Assessment based on Brazilian Requirements
  • Device Classification based on ANVISA Criteria
  • Additional regulations which apply to your device
  • In-Country Representation in Brazil
  • Registro and/or Cadastro Registration requirements
  • Medical Device Labeling Requirements
  • Costs and Timeframes
  • Regulatory Roadmap
  • Post-market Surveillance Requirements

Regulatory Affairs

Global regulatory Partner, Inc., 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 regulatory authorities.

Our Regulatory affairs teams 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 new markets and maximize the value of their assets.

Product registration

The first step in the Brazil regulatory process  is to determine the correct classification of your medical device. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. Higher risk Class III and IV devices must follow the Registro registration process. The next step is, for all classes: you should appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).

If your device is Class I or II, you must submit an application and legal documents to ANVISA for review and approval, Class I and II device manufacturers must also compile a comprehensive technical dossier for their BRH to keep on file, along with proposed labeling and IFU, in case of an ANVISA audit. Class III and IV device manufacturers must prepare a Technical File including clinical data, clinical studies, and additional device information in accordance with Annex III Part A, B or C of RDC 185/01 and submit to ANVISA.  Legal documents, IFUs, and proposed labeling are also included in the Technical File.

If your medical device is subject to IEC 60601, you likely need to obtain National Institute of Metrology, Standardization and Industrial Quality (INMETRO) certification from an authorized local certifier in Brazil.

Let Global Regulatory Partners assist you with Brazil’s regulatory approval process.

  • We can determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration.
  • Appointing us as your Brazilian Registration Holder will allow you to maintain more control over your registrations and to add or remove distributors at any time.
  • Our experienced consultants can update your existing FDA or ISO 13485 compliant quality system to meet Brazil’s Good Manufacturing Practice (GMP) requirements.
  • We can assist you with INMETRO certification coordination, if necessary.
  • Medical devices in Brazil are classified using a set of 18 rules found in Annex II of Brazilian RDC 185/01 published by ANVISA.

Classification of medical devices in Brazil is as follows:

Classification of medical devices in China:

Device Class Description
Class I Lowest Risk
Class II Low Risk
Class III Moderate Risk
Class IV High Risk

Medical writing

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 different heath authorities before starting key milestone of your product development such as GRP regulatory affairs team supports includes: writing , preparation and submission 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.  GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

REGISTRATION PATHWAYS

Device Class Description
Class I and Class II Devices Cadastro registration process
Class III and Class IV Devices Registro registration process

Medical Device Registration Process

  • Determine classification of your device using rules found in Annex II of Resolution RDC 185/2001 published by ANVISA (Agência Nacional de Vigilância Sanitária). The Cadastro registration is for lower risk devices, has a simplified application, and typically takes less time than Registro
  • For all classes:
    • Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).
    • Provide Letter of Authorization to your BRH, who will submit your registration application to ANVISA. Your BRH maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable.
    • Certain devices* require INMETRO Certification. Testing for electro-medical products performed outside Brazil is usually accepted, if performed by an ILAC-certified lab (CB Scheme is not accepted).** Compile tests and pay fee to INMETRO Certifier. INMETRO certification is valid for 5 years, and annual audits and fees are required.
  • Class I and II device manufacturers must comply with BGMP requirements. However, ANVISA will not conduct an audit.
  • Class III and IV manufacturers must be audited for BGMP compliance by ANVISA as outlined in RDC 16/2013. BGMP fees are due every two years.
  • For Class I and II (Cadastro): Prepare Technical Dossier and Cadastro application. Send legal documents, as well as proposed RDC 185/2001-compliant labeling (IFU and labels) to BRH. These files are maintained by the BRH in case of ANVISA on-site inspections.
  • For Class III and IV (Registro): Prepare Technical File, including clinical data, clinical studies (if applicable), information on your device in accordance with Annex III, Part A, B, and C in RDC 185/2001, and proposed labeling (IFU and labels) per Annex III Part B.
  • For all classes: BRH prepares and submits the application to ANVISA. All documents must be submitted in Brazilian Portuguese. Pay application fee.
  • For all classes: ANVISA reviews registration application. Upon approval, ANVISA will publish registration number in the Diário Oficial da União (DOU).
  • Class I and II registrations do not expire.
  • Class III and IV registrations are valid for 5 years. Registration renewals must be initiated one year, and no later than six months, prior to expiration.
  • For all classes: Appoint a qualified importer/distributor to bring your device into Brazil. You may now begin marketing your device.

Application Review Timelines

Device Class Approval Time
Class I 1-3 months
Class II 1-3 months
8-15 months Moderate Risk
Class IV 8-15 months

In order to qualify for these abbreviated review times, you must either file a lawsuit against ANVISA to force a BGMP inspection within 6-8 months or leverage the ABIMED route when you submit your registration. In order to leverage ABIMED you must appoint a Brazil Registration Holder who is an ABIMED member (Global Regulatory Partners is a member) and have an existing ISO 13485 certificate (or other internationally accepted GMP certificate). Companies must still schedule and pass a BGMP audit by ANVISA while the registration proceeds in parallel, and ANVISA reserves the right to revoke the registration at any time due to noncompliance.

Device Class Description of Requirements
Class I and Class II Devices Legal Documents Technical Dossier (STED Format) Proposed RDC 185/2001-compliant labeling (IFU and Labels) to BRH
Class III and Class IV Devices Technical File (including): a) Preclinical Testing b) Clinical Testing Proposed Labeling and IFU as per Annex III Part B Information on your device in accordance with Annex III, Part A, B and C in RDC 185/2001

Quality

Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. The requirements for medical devices are specified in Brazilian resolution RDC 16/2013.

In 2009, Brazil’s regulatory agency (ANVISA) issued a resolution, RDC 25/2009, that made Brazilian GMP certification mandatory for many medical device manufacturers. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical and IVD devices.

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES IN BRAZIL

Brazil’s GMP regulations most closely resemble the internationally recognized ISO 13485 standard, and similar to Europe, ANVISA conducts inspections of medical device manufacturers to determine BGMP compliance. ANVISA will only approve device registrations after successful completion of a BGMP audit. ANVISA has supported the MDSAP program and is an active member of IMDRF. Implementation of MDSAP in Brazil can greatly reduce the burden on the manufacturers and save time and resources. With offices in Brazil and worldwide, Global Regulatory Partners has expertise with a wide range of quality management systems including FDA QSR, ISO 13485, Japan Ordinance 169. As a result, we know how to upgrade your existing QMS to comply with Brazilian GMP requirements.

  • We can modify your existing QMS to meet Brazil’s GMP requirement.
  • Our in-depth knowledge of the Brazilian regulations ensures that your quality systems will be up to date.
  • We have experience assisting hundreds of manufacturers with BGMP compliance, ANVISA registration and other regulatory consulting services.

Pharmaceuticals

Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.

Through our local office in Tokyo, GRP can act as your local authorized agent in Japan 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.

Authorized local agent

Brazilian Health Regulatory Agency (ANVISA) requires that any Foreign medical device company, without a physical location in Brazil, who intends to sell its product in the Federative Republic of Brazil to appoint a Brazilian Registration Holder (BRH).

 GRP-Brazil is licensed by ANVISA to act as your BRH:

  • Control your registrations and your BGMP certification. 
  • Communication with ANVISA 
  • Product Registration
  • Assistance with ANVISA inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support ANVISA consultation meetings.
  • Recall or incident report assistance 
  • Manage Distributors
  • License Renewal                                                

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.

Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in different markets.

Regulatory Strategy

GRP’s approach to designing regulatory strategy employs our strong understanding of the global markets and regulatory systems to enable our clients to make confident, actionable decisions. We specialize in assisting pharmaceutical companies with their most difficult, complex endeavors in Asia, and can help our clients to develop intelligent solutions in all areas.

Our regulatory team in Brazil has the expertise in developing effective and tailored regulatory strategies that helped many foreign companies to register their products quickly and efficiently.

To develop the correct regulatory strategy that meet companies’ goals, our local team:

  • Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
  • Proactively identify challenges or issues that may delay the approval of your pharmaceutical in Brazil.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your pharmaceutical product registered in Brazil.

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’s registration, products’ life cycle management and maintenance.

Product registration

The federal regulatory agency responsible for pharmaceutical product registration in Brazil is ANVISA (National Sanitary Vigilance agency), which was established in 1999. The 1999 Law (The Generics Law) and the ANVISA regulate the implementation of generic pharmaceuticals policy in Brazil, establishes the technical standards and defines the concepts of bioavailability, bioequivalent drugs, innovators, reference drugs, and similar. According to the Brazilian legislation, all the pharmaceutical products must be registered with ANVISA before coming to market in Brazil. Product registration in Brazil is a laborious exercise and is to be requested by the local Brazilian based office of the foreign company or its distributor in Brazil.

ANVISA classifies the products in various categories. The medications for human use are divided into three distinct areas i.e., New Product, Similar Product, Generic Product

Registration Pathway

Technical Regulation for the registration of Active Pharmaceutical Ingredients (APIs) in Brazil

APIs, including imported ones, shall not be industrialized, exposed for sale, or commercialized in Brazil before being registered by ANVISA, except the API that will be used for scientific or technological research, as well as for research and development of formulations.

The registration will be valid for five years and may be revalidated for equal and successive periods of time, the initial record number being maintained.

Technical Regulation for the registration of Biologics/Biosimilars in Brazil

A “biological product” is a biological that is not new or is known and contains a molecule with known biological activity that is already registered in Brazil (namely, with ANVISA) and has undergone all stages of manufacturing (namely, formulation, bottling, lyophilization, labeling, packaging, storage, quality control and release of the biological product batch for use).

To register a new biological product or a biological product, an applicant company (applicant) must file a registration application (which must be submitted in Portuguese with one copy of the entire application being provided on a CD-ROM in a pdf format). Any documents included in a foreign language must be translated.

Clinical Research

The Brazilian National Health Surveillance Agency (Anvisa) has published a final resolution on new rules to expedite the authorization of clinical trials of medical products in Brazil.

Under the new regulation, Anvisa will have two new deadlines to evaluate the Drug Clinical Development Briefings (DDCM), which contain the clinical trials applications to be carried out in Brazil:

  • A 90-day period for reviewing international Phase III clinical trials of synthetic medicines: if Anvisa does not reply within the 90-day period, the sponsor may start the clinical research, provided it obtains approval from the responsible ethics review boards.
  • A 180-day period for reviewing local Phase I and II clinical trials: for this group of trials, the clinical research cannot begin until an official Anvisa decision.

The new regulation aligns with Anvisa’s policy of improving the process for pharmaceutical companies to access the Brazilian market. In fact, recently Anvisa introduced new regulations that facilitate some of the internal processes such as marketing authorizations and the process for importing drugs.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in the US, European Union, Japan, China, LATAM, and ASEAN.  GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

Global Regulatory Partners Inc. (GRP) Regulatory operation services include 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.  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.

Medical writing

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

In general, it is highly recommended to have a pre-consultation meeting with health authorities such as FDA, EMA, PMDA, ANVISA, NMPA, TGA during the development of new pharmaceutical or biologic products. 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 different heath authorities before starting key milestone of your product development such as

GRP regulatory affairs team supports includes: writing , preparation and submission 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.  GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

Medical Writing

In general, it is highly recommended to have a pre-consultation meeting with health authorities such as FDA, EMA, PMDA, ANVISA, NMPA, TGA during the development of new pharmaceutical or biologic products. 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 different heath authorities before starting key milestone of your product development such as

 

GRP regulatory affairs team supports includes: writing , preparation and submission 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.  GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

Clinical

The new Clinical Research Regulations (for Medications and Devices) for ANVISA were published on March 03rd and became in force on the day of its publication:

The new rules were created considering the guidelines and processes of international Regulatory Authorities (FDA, EMA, etc) and aims to optimize ANVISA’s resources and significantly reduce the evaluation timelines.

Requirements for conducting clinical trials

All key highlights of the new Rules:

  • Substantial Amendmentsrelated to Protocol or Drug (or Device) Development Program will be approved by ANVISA. The timelines for this review is the same listed above.
  • Import License (IL):It will no longer be required to submit a formal IL application to ANVISA, the medications/materials may be imported after ANVISA approval is in place. The responsibility of evaluating the import process and required docs will now rely on the Airport Customs.
    The only exception is for IL of “controlled drugs” (according to specific ANVISA regulations – for example: psychotropic drugs) – for these drugs, a pre-approval is required prior to shipment.
  • Observational, Phase IV (except with vaccines) and Class I or II Device studies (RA classification of device risk, considered as lower)are NOT required to be submitted to ANVISA, unless there is any import procedure required as part of the study. If importation is needed, then only a notification is needed, and a specific approval is to be issued within 30 working days.
  • There will no longer be an individual evaluation for each clinical trial by ANVISA. Under the new rules, a Drug (or Device) Development Programis to be submitted and evaluated by RA, containing the information about previous clinical trials already conducted, clinical trials planned to be conducted in Brazil, and technical information about the Investigational Medication/Device (as Manufacturing Process, Quality Control, Stability Tests, etc). The Drug (or Device) Development Program must be submitted to ANVISA when the sponsor plans to conduct a clinical trial in Brazil (For the initial submission of the Drug (or Device) Development Program, at least one clinical trial must be notified in ANVISA system).
  • The Drug (or Device) Development Programmust be submitted by Sponsor’s local affiliate, or by a CRO located in Brazil (only in cases when the Sponsor has no office in Brazil).
  • Whenever a clinical trial informed in an already-approved Development Program is expected to start (i.e. has received the Final Protocol), a much-reduced trial dossier only needs to be notified to ANVISA, linked to this master Drug Development Program. The Ethics Committee (EC) approval is one of the documents required.
  • ANVISA Fees:there will have a fee for the submission of the Drug Development Program, and a fee for the notification of the individual clinical trials.

Fixed and established review timelines:

  • Development Programs involving Phase III trials with synthetic medications, or involving Class III or IV Device studies:ANVISA will have a 90-day timeframe to evaluate and raise any requirement. After the 90-day deadline, an automatic approval will be granted by ANVISA (for importation purposes) and the Sponsor/CROs are free to initiate the study in Brazil, provided that the applicable ethics approvals are already in place.
  • Development Programs involving Phase I and II trials, use of biological medications or vaccines, or national clinical trials:ANVISA expects to evaluate within a 180-day timeframe. Due to the increased risk involved with this type of studies, after the 180-day deadline the study cannot be started until a formal approval from ANVISA is granted. The timeframe established is only a target that ANVISA will actively work towards reaching and maintaining.
  • Serious Adverse Events (SAEs):ANVISA establishes the following timelines:
    Investigator must notify sponsor about SAEs in up to 24h.Sponsor must notify ANVISA the SAEs that are unexpected and possible, probable or definitely related to the Investigational Product in 7 calendar days (in case of fatal events) or in 15 calendar days (for other events). These notifications are performed electronically, in ANVISA website.
  • Development Safety Update Report (DSUR):ANVISA will now require the notification of the DSUR, following international timelines.
  • Annual Reports:Annual Reports related to the individual clinical trials must be notified to ANVISA. The annual report must be notified in up to 60 days considering the “birthday” of the beginning of the clinical trial in Brazil (beginning of the clinical trial in Brazil = inclusion of first subject in Brazilian sites).
  • Final Report:a Final Report related to the individual clinical trial must be notified to ANVISA.
    It must be notified to ANVISA up to 12 months after the end of the clinical trial (globally).
  • Drug (or Device) Development Program suspension or cancelation:Decision on suspension or cancelation must be informed to ANVISA in up to 15 calendar days. In case the Drug (or Device) Development Program or clinical trials is suspended as an immediate safety measure, sponsor must notify ANVISA in 7 calendar days, with a rational for the suspension.
  • Independent Safety Monitoring Committees:The new Resolution indicates that phase III trials must be followed by Independent Safety Monitoring Committees. If a phase III trial does not have this type of independent committee, a justification must be submitted.

For more information:

Medical Writing

National and international companies manufacturing pharmaceutical drugs, vaccines and related products in Brazil are, of course, subject to inspection by officials from ANVISA (Agência Nacional de Vigilância Sanitária, the National Health Surveillance Agency). In recent years, ANVISA inspectors have, in increasing scale, also been encountered outside of Brazil, focussing their efforts on enterprises marketing pharmaceutical products in Brazil. Such inspections are based on the Brazilian GMP guidelines the latest edition of which was published as Resolution Anvisa RDC No 17 dated 16 April 2010.

QUALITY COMPLIANCE FOR PHARMACEUTICALS IN BRAZIL

Brazil’s GMP regulations are based on WHO GMP guidelines, and it is closely aligned to FDA and EMA GMP guidelines.

Our pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services include:

  • Full or “as needed” consulting for ISO and/or GMP quality assurance and regulatory affairs.
  • Audits of your quality management system or a supplier’s quality system.
  • Review of corrective actions and recommendations for resolution.
  • Supporting quality metrics and analysis as part of the management review meetings.
  • Internal auditor training, risk management, quality system, or other training needs.
  • Complaint handling, contract review and surveillance audits.
  • Document control and maintenance of the quality system.

Local Agent Representation for Medical Products in Brazil

Foreign pharmaceutical manufacturers that do not have a physical location within Brazil must appoint a Brazilian (Pharmaceutical) Registration Holder (BRH). This company acts as a liaison between your company and Brazil’s National Health Surveillance Agency (ANVISA) and is responsible for your pharmaceutical registration in Brazil.

Many pharmaceutical companies elect to have a distributor coordinate their pharmaceutical registration with ANVISA. Distributors welcome this opportunity because they know that the name of the Brazil Registration Holder (their company) must be identified on the pharmaceutical registration certificates issued by ANVISA and they will “own” that approval for 5 years or more.

Most pharmaceutical companies, in a rush to enter the Brazilian market, don’t realize this until it’s too late. This could present serious issues for you as a manufacturer if you have a need to change distributors.

Cosmetics

In Brazil, Cosmetics  are regulated by the Brazilian Health Regulatory Agency (Anvisa) under Resolution RDC 7/2015 that was amended by Resolution RDC 237/2018 related to personal hygiene products, cosmetics and fragrances market authorization in brazil.

In Brazil, Cosmetics are defined as products “Used in the  preparations of natural or synthetic substances, for external use on diverse parts of the human body, skin, hair, nails, lips, external genital organs, teeth, and mucous membranes of the oral cavity, with the sole or main objective of cleaning them, perfume them, alter their appearance and/or correct body odors, and protect and maintain them in good condition”. Anvisa classifies cosmetics in two categories, Grade I and  Grade II based on their risk to users .

There are two ways for Cosmetics to be authorized into the Brazilian Market: Pre-market Approval Registration or Advanced Notification. Products listed in Annex VIII are subject to the pre-market approval procedures and products that are not are exempt from pre-market approval and are only subject to a notification procedure. 

Foreign manufacturers that want to import cosmetics products into Brazil need to assign an Authorized Local Agent who will handle their products’ registration in the country.

Global Regulatory Partners Inc., affiliate in Brazil (GRP-Brazil) is authorized by Anvisa and can help your company find the right regulatory pathway for your cosmetics in Brazil. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in Brazil and find the appropriate local distributor for your product.

Authorized local agent

GRP Inc. has local offices in the Brazil and is licensed by the Anvisa to act as your authorized local representative.  GRP Inc. can act as your local agent in Brazil for your cosmetic and Personal Care Products. GRP Inc.  can make sure your cosmetics and PCP comply under Resolution RDC 7/2015 that was amended by Resolution RDC 237/2018.

GRP Inc. Cosmetic Services:

  • Authorized local Agent
  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

Cosmetics are regulated differently from country to country. While some countries require registration of cosmetic products others only require a notification. GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in a market.

Regulatory Strategy

Developing the right regulatory strategy for your products for different markets 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 and for different markets. 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, your product development status and milestones, your 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 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, Inc. 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 regulatory authorities. Our Regulatory affairs teams 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 new markets and maximize the value of their assets.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc., 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 local and /or regional requirements and the products can be used safely by consumers. GRP Inc. can review your products and make sure they comply with Resolution RDC 237/2018.

Product classification & Formulation Review

Global Regulatory Partners Inc. 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 Inc. can review your products and make sure they comply with Resolution RDC 237/2018.

 

Nutraceuticals

Global Regulatory Partners, Inc. (GRP), has a team of experts in Brazil who can help Nutraceutical and food supplements companies in Japan 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.

GRP Inc. Nutraceutical Services:

  • Authorized local agent
  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

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 Inc. 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.

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 recommendations for the commercialization of your Nutraceuticals in different markets.

Regulatory Strategy

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 recommendations for the commercialization of your Nutraceuticals in different markets.

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 Inc. can review your products and make sure they comply Anvisa regulation.

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. GRP team 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 Anvisa standards and regulations.

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