Medical Devices

China’s Health Authority:

In China, Medical Devices are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).Due to the rise of complex technologies and constant change of the regulatory environment, regulatory affairs professionals in the Medical Device Industry are facing many challenges  to keep up with the new technologies and new National Medical Product Administration (NMPA) regulations and guidelines, to be able to define the correct pathway for their products development and registration with the  NMPA.

NMPA’s Medical Device Definition:

Medical devices are defines as  instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly on the human body, including the required computer software; their utility is mainly obtained through physical methods, Not obtained through pharmacological, immunological or metabolic methods, or although these methods are involved but only play an auxiliary role; its purpose is:

(1) Diagnosis, prevention, monitoring, treatment or relief of diseases;

(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;

(3) Examination, substitution, adjustment or support of physiological structure or physiological process;

(4) Support or maintenance of life;

(5) Pregnancy control;

(6) Provide information for medical or diagnostic purposes by examining samples from the human body.

GRP Services:

Global Regulatory Partners Inc.  (GRP), has offices in Shanghai and Beijing with teams of regulatory affairs, clinical, quality and pharmacovigilance experts who can collect the regularly intelligence develop the appropriate regulatory strategy and register successfully your medical device or IVD with the NMPA.

More Resources:

China’s Medical Device Authority:

The National Medical Products Administration (NMPA) formerly known as The Chinese Food & Drug Administration (CFDA) under the Ministry of Health (MOH) oversees all medical device and in-vitro diagnostics registration.

Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents Regulations:

  • The Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)-main regulation
  • Administrative Measures for Medical Device Registration(CFDA Order No. 4 2014), Registration of In Vitro Diagnostic Reagents(CFDA Order No. 5 2014)
  • The Provisions of Medical Device Classification (classification catalogue of medical devices)
  • Administrative Rules for the Instructions and Labels of Medical Devices(CFDA Order No. 6 2014)
  • Administrative Measures for the Supervision of Medical Device Manufacturing(CFDA Order No. 7 2014) and Distribution(CFDA Order No. 8 2014)
  • The Quality Management Practices for Medical Device Manufacturing (CFDA order No. 64 2014-GMP), Distribution (CFDA order No. 58 2014-GSP), Clinical Trial(SFDA notice No. 68 2012-GCP).

China’s Regulatory Authorities  hierarchy:

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

GRP China is licensed by NPMA to act as your Local Agent in China.

GRP- China Local Agent Services:

  • Communicate with the NMPA
  • Assist with NMPA inspection
  • Adverse Effect Reporting
  • Establishment registration and product listing
  • Product registration
  • Organize and support NMPA consultation meetings.
  • Support importation process
  • Provide support and manage product local testing
  • 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. 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

The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. Most of the Chinese regulations are in Chinese and are changing continuously.

GRP’s RA team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China. GRP’s team makes sure that its clients are kept informed of changes in the regulatory environment that may impact their regulatory and business strategies in China.

Our regulatory team in China has the expertise in developing effective and tailored regulatory strategies for medical device companies that helps them get their products successfully registered in China, in timely manner.

GRP Regulatory Strategy Services in China:

  • Device classification as per NMPA
  • Assess Clinical Trial requirements and exemptions or CER
  • In case of CER, evaluation of technical clinical information of a predictive/prototype CFDA approved device or review of existing clinical trial data standards.
  • Technical document preparation and gap analysis
  • Safety, quality and efficacy assessment

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.

GRP Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Operations and publishing
  • Product Registration
  • Products’ life cycle Management and Maintenance.

GRP’s Regitration Services in China:

Product registration

Medical Device Classification is  based on Intended use, Structural Characteristics, form, operation, and Intended Use. 

Table 1: Classification of medical devices in China:

Device Class Description
Class I The safety and effectiveness of the device can be ensured through routine administration.
Class II Further control is required to ensure the safety and effectiveness of the device.
Class III The device is implanted into the human body; used for life support or sustenance; or pose potential risk to the human body, and thus must be strictly controlled in respect to safety and effectiveness.

Medical Device Application Content:

  • Application form
  • Safety and efficacy specification list
  • Device Summary report
  • Study report (product design, developed and verified report)
  • Risk assessment report
  • Product test reports
  • Clinical evaluation documents
  • Product technical documents(product standard documents)
  • Manufacturing process explanation
  • Self assurance statement
  • Draft instructions and Labels

Average Review Timelines:

  • Class I- 1 week, Class II & III- 12-20 months
  • Sample Testing-6 months
  • CFDA Preliminary review and issue of acceptance notice- 5 days
  • CMDE review-6 months
  • CMDE Final approval-10 days
  • Updates- to be filed within one month
  • Renewal- 6 months before expiration date

Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms.

Device should be approved in original country before it is registered in China. Every medical device should be registered with NMPA for getting market access in China. If you require assistance with obtaining approval for your medical device in China, at Global regulatory Partners Inc., (GRP) we can help you prepare the necessary documents and register your product with the Chinese regulatory authorities.

GRP’s Registration Services in China:

 Regulatory Submission and approval:

  • Compilation of technical documents and registration application
  • Dossier translation
  • Clinical testing support and management
  • Risk assessment, QMS audit and compliance
  • Self assurance statement preparation
  • IFU and Draft label preparation and translation
  • Labelling and artwork compliance
  • Local agent support, attend review meetings
  • Liaison with HA until approval
  • Import permit and custom support

Post Market Compliance:

  • Monitoring and reporting adverse events
  • Product recall
  • HA query responses to regulatory and audits
  • Quality management system (GMP and GSP compliance)
  • Review of extrapolating studies
  • Advertisement and promotional material regulatory compliance and approval
  • License renewals and updates- technical document review and filing

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. GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

GRP regulatory affairs team supports includes:

  • 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. 

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.

Clinical

Exempted from Clinical Trials:

  • Class I
  • Device Listed in Catalog of Medical device exempted from Clinical Trial
  • Device comply with National or Industrial Standards

China’s GCP requirements:

Medical Device clinical trials in China must comply with China’s GCP requirements. It is important to determine if the device requires the clinical trials. This can be decided based on the classification of the device.

As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.

GMP requirements:

The trial must be carried out by an organization certified to conduct drug clinical trials, using drugs from manufacturing facilities that follow Good Manufacturing Practices (GMP).

Clinical Trial Application Process in China:

The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the NMPA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.

After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the NMPA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the NMPA. The NMPA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.

After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.

GRP’s Clinical Trial Services:

  • CRO Oversight and Management
  • Clinical Trial Application (CTA)
  • Pre-clinical Investigation of Medical Devices
  • Clinical Trial Protocol Design and Writing
  • Clinical Trial Auditing and Quality Assurance
  • Data Management and Statistical Analysis
  • Clinical Studies Report Writing

Quality

NMPA’s GMP requirements:

The NMPA has issued various regulations to strengthen management and organization at medical device manufacturing sites. This includes implementing Good Manufacturing Practice (GMP) standards for all medical devices, a more stringent adverse events and recalls system, additional on-site inspections, and other new industry standards. In addition to the NMPA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries out safety, certification, and inspection of certain medical devices to ensure adherence to quality standards.

However, despite the improving standards and implementation of GMP regulations for medical devices in China, there are still many scandals regarding defective products due to poor quality systems. Foreign companies will need to conduct audits in order to ensure that their operations or partners in China are performing according to expected standards.

Required On-site Audits:

There are two types of on-site audits that are required in China: a one-time quality management system (QMS) audit for registration that domestic and foreign manufacturers must complete, and a GMP audit for a manufacturing license after registration that local manufacturers must complete annually. Requirements for these audits include an on-site audit checklist as well as multiple company meetings.

CHALLENGES TO MEETING GMP STANDARDS IN CHINA

  • In some factories in China, there are no organized or centralized quality manuals that employees can readily access. As a result, quality control in these factories may be minimal. Thorough audits can help locate the areas that are deficient and update the quality systems to meet Western standards.
  • There may be poor document control and reporting inconsistency.
  • if procedures change, the changes are usually not documented. When a device is reported as having failed, some factories do not investigate or report the adverse events. Having the factory audited can help identify post-market surveillance issues and set up systems for reporting adverse events.
  • Even after a factory is GMP compliant and a good quality system is set in place, problems will still arise if employees are not invested in the process.
  • It is essential that those employed by the medical device factory upkeep the maintenance required to guarantee an effective quality system. Many do not understand (or care about) the ramifications of poor-quality control or intellectual property theft.

GRp’s Quality Control and Assurance services:

  • NMPA Audit preparation
  • QMS implementation and monitoring compliance
  • SOP writing and implementation
  • Quality manual writing
  • Ethics standard implementation and monitoring
  • Ethical review of clinical protocol
  • GxP Compliance

china

Pharmaceuticals

China’s Health Authority:

In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).

NMPA Drug Categories:

  • New Drugs, Class 1: innovative new drugs that have never been marketed anywhere in the world
  • New Drugs, Class 2: improved new drugs that have never been marketed anywhere in the world
  • Generic Drugs, Class 3: generic drugs, with equivalent quality and efficacy to the originator’s drugs, which are marketed in other countries, but not yet in China
  • Generic Drugs, Class 4: generic drugs, with equivalent quality and efficacy to the originator’s drugs, that are already marketed in China
  • Imported Drugs, Class 5: drugs that have been marketed in other countries, but not yet in China

GRP Pharmaceutical Services in China:

Our local offices in Shanghai and Beijing in can act as your local authorized agent in different countries 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:

China’s Pharmaceutical Regulatory Authority:

The National Medical Products Administration (NMPA) formerly known as The Chinese Food & Drug Administration (CFDA) under the Ministry of Health (MOH) oversees all new drug registration approvals.

Pharmaceutical Regulations:

  • Drug Administration Law of the People’s Republic of China (Dec. 01, 2001)
  • Regulations for Implementation of Drug Administration Law of the People’s Republic of China (Sept. 15, 2002)
  • Regulations on Administrative Protection for Pharmaceuticals (Jan. 31, 1993)

Pharmaceutical Policies:

  • Provisions for Drug Registration (July 10, 2007)
  • Special Review and Approval Procedure for Drug Registration (Nov. 18, 2005), revised in 2009

China’s Regulatory Health Authorities Chart :

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

 GRP  is licensed by NPMA to act as your Local Agent in China.

GRP Local Agent Services in China:

  • Communicate with the NMPA
  • DFM Submission
  • Assist with NMPA inspection
  • Adverse Effect Reporting
  • Establishment registration and product listing
  • Product registration
  • Organize and support NMPA consultation meetings.
  • Support importation process
  • Provide support and manage product local testing
  • 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 China’s market.  

Regulatory Intelligence| Global Regulatory Partners Inc.

Regulatory Strategy

The regulatory process from product design to market entry for a new drug is oftentimes complicated and unclear. Most of the NMPA regulations are in Chinese and are changing continuously. Our regulatory team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China. Our regulatory team in China makes sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in China.

GRP Regulatory Strategy Services (China) :

  • 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 China.
  • 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 China.

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 regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s 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 Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in China.  GRP’s 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.

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

The process of drugs registrations in China depends on the category they belong to. NMPA classifies drugs is three categories:

  • Chemical [ 6 Classes ]
  • Biological  [ 15 Classes ]
  • Traditional Chinese Medicine [ 9 Classes ]

All drugs and drug substances (APIs) manufactured outside China must be registered via the imported drug application. Foreign-made APIs need to undergo a process like drug registration. Even if a product is approved elsewhere, the NMPA will most likely still require the foreign manufacturer to conduct at least some clinical testing in China before the drug is approved in China.

Registration Pathways:

  • New Drug
  • Import Drug
  • Generic Drugs
  • Dietary Supplements
  • Drug re-registration

New Drug Registration Process:

Application Steps: 

  1. Clinical Trial Application (CTA or IND)
  2. Marketing Application (NDA)

Review Stages:

  1. Provincial NMPA Review
  2. NMPA Review 

Average Review Timelines:

  • IND- 6 months
  • Bridging Clinical Trial- 13.5 months
  • NDA- 11 months
  • ANDA- 14 months
  • Supplementary Application- 5 months
  • Import re-registration- 4 months

More Resources:

Provision for  Drug Registration.http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390615.htm

Good Manufacturing Purpose for Drugs. (2010). http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390613.htm

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 or badly translated documents can raise  NMPA  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.

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. For more information on health consultations check out our resource center or contact us.

Clinical

As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.

In some cases, as an alternative to local clinical studies, a bioequivalence (BE) study will be required instead. The BE study will test similarities between two drugs believed to have the same active ingredients and use.

Clinical Trial Application Process in China: 

The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the NMPA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.

After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the NMPA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the NMPA. The NMPA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.

After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.

NMPA Clinical Trial Phases:

The NMPA’s Drug Regulatory Department oversees local clinical trials and affirms compliance with GCP. Generally, clinical trials in China involve four phases:

  • Phase I – an initial review of the drug’s safety to humans
  • Phase II – an evaluation of the effectiveness of the drug
  • Phase III – a confirmation for the effectiveness of the drug
  • Phase IV – a post-marketing study

Clinical Site Requirements:

The trial must be carried out by an organization certified to conduct drug clinical trials, using drugs from manufacturing facilities that follow Good Manufacturing Practices (GMP).

Reporting of AE or SAE:

If there is a serious adverse event, investigators must notify the PFDA and applicants within 24 hours, and the ethics committee thereafter. If an event is serious, the PFDA may suspend or terminate the trial. A trial may also be terminated due to fraud, ethical concerns, and failure to report adverse events.

GRP’s Clinical Trial Services in China

GRP’s Clinical Trial Expertise:

An understanding of the regulatory requirements in China and experience in dealing with the NMPA is essential in administering a smooth, successful clinical trial in China. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in China. Our local teams and affiliated partners located in China and all-around Asia 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.

Clinical trials that are conducted properly in China will facilitate a smooth registration approval process and expedite access to other Asian markets. If you need assistance with clinical trials for your medical product in China, contact us for a consultation with our regulatory experts.

  • 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 Singapore. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate HSA 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.

Cosmetics

China’s Health Authority:

In China Cosmetics are regulated by the National Medical Products Administration (NMPA) under the Regulations Technical Safety Standard for Cosmetics of 2015. Before a cosmetic product is put on the market, the manufacturer must carry out a sanitary quality inspection of the product in accordance with the State’s “Cosmetic Hygiene Standards”, and products that pass the quality shall be marked with a pass mark. Products that have not been inspected or do not meet sanitary standards cannot be sold in China.

NMPA Definition of Cosmetics:

The regulation defines cosmetics as: “Products that can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc.), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means”.

NMPA Cosmetic Categories:

Cosmetic products are divided into two categories: Non-Special Use Cosmetics (Non-SUC) (such as hair care, skin care, nail products, and fragrances), and Special-Use Cosmetics (SUC) (such as hair regrowth products, deodorants and sunscreens). Cosmetics require different pre-market applications depending on their category.

Cosmetic Product Registration:

Foreign manufacturers that want to import cosmetics (SUC and Non-SUC) products into China need to assign an Authorized Local Agent who will be responsible in  handling the products’ registration in the country.

GRP Cosmetic Services:

Global Regulatory Partners Inc., affiliate in China (GRP- China) can act as your local representative in China and can help you find the right regulatory strategy to commercialize your Cosmetics in China. GRP-China team of professionals in Beijing and Shanghai offices, can register your cosmetics in China, review the formulation and labeling of your Cosmetics in line with NMPA regulations.

More Resources:

  • ‘Read More‘ To access more information on Cosmetics and GRP’s services in China.

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China. China has two categories of cosmetics – non special use cosmetics (non-SUC) and special use cosmetics (SUC), and the approval process differs for the two categories. Non- SUC have to go through the pre-market filing process, and SUC are subject to pre-market registration. Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and import your cosmetics (SUC and Non-SUC) products into China.

GRP- China Cosmetic Services:

  • Authorized local Agent
  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Affairs (RA)
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

China’s Cosmetic Market:

 China’s Cosmetic Market size was forecasted to continue to grow and amount to approximately 485 billion yuan by 2021. Skincare products dominate cosmetics market in China and produced over 190 billion yuan in 2018. In comparison, hair care was valued at around 55 billion yuan, with the bath and shower product market amounting to nearly 23 billion yuan.

China’s Consumers:

The majority of consumer for cosmetic products are among the post-80’s, post-90’s generations and “Generation Z”, broadly defined as those born on or after 1998. Gen Z already makes up 30% of the global population and around 20% of China’s population.

These consumer groups are  highly aware of  appearance and trendiness of the products. As a result, various cosmetic brands are witnessed an increase rate of   collaborations with TV/film stars, beauty bloggers, and “product placement” in entertainment events and films/TVs as a way to boost up the sales of cosmetics. However, the consumer’s attitude towards cosmetics market has drastically changed in China.  Now, less are influenced by the media advertisement and prefer research a product.

TOP Brands:

Japanese, Korean, European and American brands have long dominated the cosmetics market in China. In 2017, only 3 Chinese brands ranked among the top ten cosmetics brands in China, namely Shanghai CHICMAX (sub-brands: KANS, One leaf, etc.), Shanghai Pechoin (sub-brands: Pechoin, Sansen, etc.) and JALA Corporation (sub-brands: CHANDO, MAYSU, etc.), while the rest were foreign brands.

GRP Regulatory intelligence (RI) services:

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. For more information on Cosmetic Regulatory Intelligence in China check out our Resource Center.

Regulatory Strategy

GRP Regulatory Strategy Services:

Developing the right regulatory strategy for your products is crucial for successful product development, registration, and commercialization in China. 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. 

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.

GRP Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Operations and Publishing
  • Product Registration
  • Products’ life cycle management and Maintenance.

Cosmetic packaging and labeling review

GRP Cosmetic Registration Expertise:

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.

 

Product label and name: the applicant should concentrate on mandatory labeling items, warning statement, authentic Chinese translation of imported product label, appropriate efficacy claims and the correct SPF identification.

Imported Cosmetics Labeling Options:

Their are 2 possible options for labeling the of imported cosmetics. 

  1. Company can design the label especially for the Chinese market according to Chinese labeling regulations
  2. Company can use the original package with a China compliant over-label.

Labeling Requirements in China:

Cosmetics labels are subject to review by NMPA expert panel during registration and also checked by CIQs when products arrive at port.

According to Instruction for Use of Consumer Products—General Labelling for Cosmetics (GB 5296.3-2008), the following information shall be indicated on labels of the imported cosmetics:

  • Product name
  • Name and address of manufacturer, distributor
  • Country of origin
  • Approval ID number (the ID number on the administrative license or record-filing certificate
  • List of ingredient (all ingredients with concentration over 1.0% must be indicated with Chinese INCI names and listed in descending order of “quantity”; in absence of INCI name, the corresponding name in Chinese Pharmacopoeia, its chemical or botanical name can also be adopted) 
  • Net content
  • Production date and shelf life or the batch number and expiration date
  • Warnings (for products containing restricted substances)
  • Instruction and storage condition 
  • Other info (the local distributor or wholesaler can be indicated as well) 

Product classification & Formulation Review

In China  the Hygienic Standard for Cosmetic 2007 lists the prohibited and restricted ingredients in cosmetics.

Product Testing  in China:

In China cosmetic  must be tested by NMPA approved labs even if they have been tested and assessed as “safe” abroad. Testing items and duration depend on the type and property of cosmetic products.

Testing takes around 2-4 months for non- SUC, and it may take a year or more for SUC, which require some additional testing. Testing reports have to be included in the product’s dossier. The latter is compiled by the RA or RP, depending on the process, and it includes documentation on the quality and safety of the product.

Animal Testing:

It is important to note that China still requires animal testing of cosmetics. All imported cosmetic products, as well as domestic SUC, have to be tested at the NMPA approved labs, which perform tests on animals

Claims made by Cosmetic Products:

Manufacturers of cosmetic cannot claim functions or features that the products that are not truthful and backed on evidence. Medicinal or therapeutic function claims and any misleading wordings are prohibited.

Local expertise will be necessary regarding product compliance with China’s  requirements. a Certain claims on some imported products, such as “hypoallergenic” or  “dermatologically tested” will be challenged by the NMPA’s expert panel f not evidence is given. 

Prohibited Cosmetic Ingredient List:

China regulates banned and restricted substances in cosmetic products similarly to EU Cosmetic regulation, which includes lists of prohibited and restricted substances, colorants, preservatives, and UV filters these lists are contained in the Hygienic Standard for Cosmetics 2007, the standard that all cosmetic products and ingredients must adhere to, which also contains methods of toxicological test, hygienic chemical test and microbiological test along with efficacy evaluation methods.

Cosmetics

GRP Cosmetic Registration Expertise:

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 the NMPA regulations for cosmetics under the Technical Safety Standard for Cosmetics of 2015.

Table 1: Cosmetic Classification in China:

Non-Special use cosmetics (non-SUC)

  • Skin care products;
  • Hair care products;
  • Nail (toe) care products;
  • Make-up
  • Fragrance

Special Use Cosmetics

(SUC)

  1. Hair growth products
  2. Hair dyes
  3. Hair perming products
  4. Toothpaste
  5. Breast beauty products
  6. Slimming products
  7. Deodorants
  8. Freckle-removing products
  9. Sunscreens

Table 2: Registration Pathway of Cosmetic Product in china

Category

Pathway

Certificate

Department

Imported non-SUC

Pre-market filing

Filing certificate

NMPA

Imported SUC

Pre-market administrative licensing

Administrative license

NMPA

Domestic non-SUC

Post-market filing

Filing certificate

Provincial NMPA

Domestic SUC

Pre-market administrative licensing

Administrative license

NMPA

Nutraceuticals

NMPA Dietary Supplement Categories:

There are currently two kinds of dietary supplements in China: functional food and nutrition supplements. Functional food must be registered before entering China’s market. As it can have different functions, such as enhancing immunity, helping the protection against radiation hazards, improving sleeping quality, increasing bone density, acting antioxidants, and improving memory. Nutrition supplements are generally used to supplement and correct deficiencies with the intake of certain vitamins and or minerals.

GRP Dietary supplement Services in China:

Global Regulatory Partners, Inc. (GRP) has a team of experts in China who can help Nutraceutical and food supplements companies in China 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‘ To access more information on Nutraceuticals and GRP’s services in China.

Authorized local agent

National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and commercialize your nutraceuticals (Functional food and nutrition supplements) in China.

GRP- China 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 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

Developing the right regulatory strategy for your Nutraceuticals in 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 Nutraceuticals for different markets. GRP 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, your timelines, the regulatory requirements related to your product, cost, and risks.

With a global presence and a local team of experts, GRP 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.

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 different health authorities.

 

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