Medical Device Registration in China

• The National Medical Products Administration (NMPA), formerly known as the China Food & Drug Administration (CFDA), is accountable for supervising medical devices, drugs, and healthcare services.
• As part of the medical device registration procedure, the Center for Medical Device Evaluation (CMDE) is in charge of reviewing the documentation.
• Certain devices must undergo mandatory safety registration, certification, and inspection, which are conducted by the State Administration for Market Regulation.

Yes, medical devices require NMPA registration prior to being sold in China.

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

Class I Device: Class I medical devices no longer need to be registered with the NMPA; instead, a notification must be filed with the relevant local-level authority. However, for the notification application, more documents will be required than there were for Class I registration.

Class II & Class III Devices:

1. Chinese specification drafting (dossier preparation and specification drafting)
   Timeframe: about 1 month
2. Sample testing
   Timeframe: about 6 months
3. Do a Clinical Evaluation Report (CER) or a local clinical study                                        Timeframe:  6 months to 1.5 years
4. Filing to the NMPA (NMPA preliminary review and acceptance notice)
   Timeframe: 1 month
5. CMDE review; CMDE will issue a supplementary notice
   Timeframe: 60-90 working days.
6. Supplementary dossier preparation
   Timeframe: maximum 1 year
7. Further CMDE review
   Timeframe: 60 working days
8. NMPA final review and granting of the registration approval
   Timeframe: 30 working days

Also note that clinical trials may be required for certain high-risk devices (e.g. implantable devices).

Class I Device

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.
8. Self-declaration Letters
   • Letter to declare that the documents submitted meets the NMPA’s regulation for Class I Medical device notification.
   • Letter to declare that the product conforms to the Class I Medical Device classification catalog.
   • Letter to declare that the product conforms to the National and/or Industry standards (GB/YY) in China, and the list of these conformed standards.
   • Letter to declare that all submitted documents are true.

Please note that for all documents sent to the NMPA, the applicant should provide the Chinese translation as well.  For the legal documents listed below, the applicant should submit the original or a notified copy.

Class II & Class III Device

A total of 12 document items must be collected and submitted to the NMPA, consisting of 9 legal documents, 2 technical documents, and a testing report issued by a NMPA-certified testing center:

1. Application Form
2. Legal Documents
3. Main Safety and Efficacy Specifications List
4. Summary Data
   1. Overview
   2. Product description
   3. Product model
   4. Description of the package
   5. Intended use and contraindications
   6. Predicated device (if applicable).
   7. Other information
5. Research Data
   1. Product performance evaluation data
   2. Biocompatibility evaluation data
   3. Biosafety research data
   4. Sterilization and disinfection process validation data
   5. Shelf and package evaluation data
   6. Animal research data
   7. Software validation data
   8. Other data if necessary
6. Manufacturing information
   1. Manufacturing process description for active/inactive device
   2. Manufacturing site description
7. Clinical Evaluation Data
8. Product Risk Analysis Data
9. Product Technical Specifications
10. Registration Testing Report
    1. Testing report issued by a NMPA-certified lab
    2. Preliminary evaluation comment from the testing lab
11. Artwork for the IFU and Product Label
    1. Instructions for use (IFU)
    2. Artwork of the product label for the minimum selling unit
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, the 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 specification items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
• For each specification item, testing centers will utilize the testing method described in the Product Technical Specifications.
• While conducting the tests, the NMPA 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.
• Used to take 3 months, now 6 months or more
• Always best to send your own technical people to help the testing center, and make sure testing is done right
• Can do mock tests prior to the official submission testing

The testing report will be issued by an 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 registrations except in the following situations:

• The product has a clear working mechanism, finalized design, and mature production technology. A medical device 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 the clinical application of other medical devices of the same variety.

• Based on equivalent products already approved in China
• Equivalence refers to similarities with basic principles, structural composition, manufacturing materials, applicable standards, intended use, safety, etc.
• Need to collect and analyze literature data and clinical experience data of the equivalent device
• If your device has differences from the approved device, you must prove that these differences do not affect efficacy and safety
• If equivalence cannot be proved, and the product is not on the exempt list, a local clinical study will be needed

Yes, approval for the medical device in the Country of Origin is required before registration.