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Welcome to GPC China - Regulation

In 2003, Chinese Ministry of Ecology and Environment (MEE) introduced the regulation on the registration of New Chemical Substances (MEP Order No.7). In 2010, this regulation was revised for the first time and the Inventory (IECSC) was introduced under Order No.7.

After 9 years’ implementation of Order No.7, MEE called for the second revision of Measures for the Environmental Management Registration of New Chemical Substances, which was finally approved on February 12, 2020 (MEE Order No.12). This new regulation has come into force on January 1, 2021 and replaced the previous regulation (Order No.7).

Under the provisions of this regulation, companies shall submit registration application if manufactured/imported substance is not listed in the Inventory. All activities including research, production, importation and processing have to comply with the regulation requirements as long as the chemical substances are under the scope of this regulation. Business activities are not allowed until a certificate is granted.

The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province. The Centre for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process. The General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) conducts mandatory safety registration, certification, and inspection for certain devices. 

China has National Standard for medical devices. Any medical device must follow the Chinese National Standard Specifications. More than 35% of all the IEC and ISO standards have now been adopted by China, but many are not direct transpositions and contain China specific requirements. 

           Primary medical device related international standards and their Chinese equivalents.Graphical user interface, text, application

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  • The first step in registering your medical device in China is to classify your product in China. China classifications range from Classes 1-3. 

*Note: If the medical product is registered as a Class 2 product in the US or EU, it does not mean it will be a Class 2 product in China. 

  • The second step in registering the medical device in China is local type testing. This requires the device manufacturer to send a sample(s) of the product to China, where one of the NMPA testing centres in China will perform local type testing. 

  • The third step for Class 2 and Class 3 products is to determine whether a clinical evaluation report (CER) or a local clinical study will be needed for China device approval. Hopefully a CER will suffice, but if not, a local clinical trial may be needed. Local clinical trials in China can be expensive and normally take 1-1.5 years.

  • In June 2021, the NMPA issued a new set of regulations that will make it easier for innovative medical devices for the treatment of urgent public health emergencies and rare diseases to obtain approval in China.  

  • Certain products will be exempt from clinical trials in China if their manufacturers can demonstrate their safety and efficacy in other markets. All medical devices require CFDA registration prior to being sold in China.

  • The Chinese State Council released the new Regulations for the Supervision and Administration of Medical Devices in 2014. Compared with the old regulations (48 articles), the new ones have 80 articles and many changes on device registration; clinical trials; adverse events; recalls, etc.  

  • The new regulations are consistent with the goal of the “National 12th five-Year Plan” to foster innovation and encourage domestic companies’ research and development while enhancing the protection of public health.

 

 

  1. Product Risk Analysis Document 
  2. Product Technical Specification 
  3. Product Testing Report (company’s self-testing report or 3rd party report) 
  4. Clinical Evaluation Report 
  5. Key Manufacturing Information (process, flowchart, material, etc.) 
  6. Design/artwork of IFU and product label for the minimum selling unit 
  7. Legal Documents 
  • Legal qualification of the foreign manufacturer (i.e. ISO 13485) 
  • Market authorization approval at the country of origin (i.e. CFG+510k or CE) 
  • Authorization letter to the agent in China. 

Device Class 

Timeline 

Cost 

Period of Validity 

Class I 

Immediately 

Free: Initial/change/extension 

NA 

Class II 

  • 3 for transfer from NMPA to CMDE 

  • 60 for CMDE technical review 

  • N for company reply time (1year) 

  • 60 for CMDE technical review 

  • 10 for issuing license 

 

RMB 210,900 / 42,000 / 40,800 

(approx. EUR 26,500 / 5,300 / 5,150) 

 

5 years 

Class III 

  • 3 for transfer from NMPA to CMDE 

  • 90 for CMDE technical review 

  • N for company reply time (1year) 

  • 60 for CMDE technical review 

  • 20 for NMPA approval 

  • 10 for issuing license 

RMB 308,800 / 50,400 / 40,800 

EUR 38,900 / 6,350 / 5,150 

 

5 years 

 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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