Regulatory Services

NMPA (CFDA) is the arm of the Chinese government that sets China medical device/IVD regulations. All medical devices/IVD’s imported into China must be registered in the NMPA national office and follow all regulatory services. Domestic medical devices could be registered in the NMPA provincial office.

CMDE (Center for medical device evaluation) is the medical device registration dossier reviewing center under NMPA (CFDA). There are 6 departments in CMDE. Each one is responsible for reviewing registrations of different categories of medical devices//IVD’s.

Medical Device

• Class I: Safety and effectiveness can be ensured by normal administration.
• Class II: Safety and effectiveness should be controlled.
• Class III: Human implants; life support and substance; have potential risk to human body; the safety and effectiveness needs to be controlled strictly.

IVD

• Class III includes reagents related to: 1) the testing of pathogenic antigens, antibodies and nucleic acids; 2) blood type and tissue type; 3) human genetic testing; 4) hereditary diseases; 5) narcotic drugs, psychotropic substances and medical toxic drug testing; 6) therapeutic targets detection; 7) tumor marker detection; 8) allergen testing.
• Class II: Except for the reagents that are classified as Class I and Class III, all the other reagents are Class II.
• Class I: 1) Microbiological media (not used for microbiological identification and susceptibility testing); 2) Sample processing products, such as hemolytic agents, diluents and dyeing solution.

Class I Filing:

1. Class I medical device/IVD filing form
2. Safety risk analysis report
3. Technical standard
4. Product testing report
5. Clinical evaluation materials
6. IFU and minimum-selling-unit label-design sample
7. Production information
8. Legal documents
9. Self-declaration

Class II & III Registration

1. Application Form
2. Legal documents
3. Medical device/IVD safety and effectiveness basic requirements list
4. Summary
   • Overview
   • Product description
   • Model and specification
   • Packaging
   • Clinical indication and contraindications
   • Referred predicate product
   • Others
5. Research Materials
   • Product performance research
   • Biocompatibility evaluation research
   • Bio-safety research
   • Sterilization and disinfection process research
   • Shelf validity period and package evaluation data
   • Animal research
   • Software research
   • Other
6. Manufacturing Information
   • Production process of active/inactive device
   • Production site
7. Clinical Evaluation Materials
8. Product Risk Analysis Materials
9. Product Technical Standard
10. Product Registration Testing Report
11. IFU and Label Sample
12. Self-declaration Documents

In almost all situations for Class II and Class III devices, the NMPA will request samples for type testing. The testing centers will use the product standard to determine what tests to conduct.

• For Class II and Class III devices, NMPA will request samples for type testing. For Class I products, NMPA will accept a company’s foreign testing data.
• Testing centers will test all items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
• For each item, testing centers will utilize the testing method described in the Product Technical Specifications.
• While conducting the tests, the NMPA (CFDA) requests that testing centers provide comments on the company’s drafted Product Technical Specifications.
• The comments from the testing center should be submitted together with the testing report to avoid repeats and additional testing, which occurs frequently, leading to long delays in the registration process.

The testing report will be issued by a NMPA certified national testing center, which can be freely selected from the NMPA list. It is only valid for 1 year, and once it expires, a company must start again to obtain a new valid testing report.

Clinical trials must be conducted for all Class II & III medical device/IVD registrations except in the following situations:

• The product has a clear working mechanism, finalized design, and mature production technology. A medical device/IVD of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
• The safety and efficacy of the product can be proven through non-clinical evaluations.
• The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.

Yes. You need approval from either the country of origin or the country where the applicant is located to start the NMPA (CFDA) registration process.