CHINA: NMPA New guidelines on the Submission of the Periodic Risk Assessment Reports

Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to the National Medical Products Administration (NMPA).

The Periodic Risk Assessment Report is needed to describe the likelihood, consequences and tolerances of the possible risks of using a device. They will be required annually for the first five years for Class I, II, and III devices. Renewal of medical device products will require a new report submission.

Registrants are required to prepare the report annually for all medical devices (including IVDs) listed in China. Reports for Class II and Class III devices should be submitted to NMPA via an online system. For class I devices, the report should be kept in the registrants’ possession and only be submitted when required.

An overseas registrant of imported medical devices may submit the report in English, although a Chinese translation is required. Case reports of individual adverse events may be written in English only.

Format

Format of the NMPA report is similar to European Periodic Safety Update Report (PSUR). Report format of Periodic Risk assessment report include three parts: Cover, Table of contents and main content

Cover includes – Product name, approval date of registration certificate, product certification status (either initial or renewed), number of how many Product periodic risk assessment reports have been already submitted, reporting period, domestic sales during the period, overseas sales during this perid, number of reported adverse events, name and contact details of authorised representative, department and person responsible for product safety, contact information of registrant (manufacturer), report submission time, privacy protection and other relevant information. 

The Table of Contents should be as detailed as possible, including at least 3 sub-sections.

Main topic includes: 

1. the basic product information, 
2. the product registration status in China and overseas, 
3. risk control measures, 
4. detailed information on the adverse events that have occurred domestically as well as globally, 
5. other risk information, possibly including relevant literature or information on the risks examined in similar products, 
6. a product risk analysis, 
7. conclusions, 
8. an appendix, including product registration certification, product’s IFU, corresponding references, and other relevant documentations.

Conditional Submission of a single Report for Multiple Product Certificates

In principle, each product certificate shall be associated with the corresponding individual Report. However, NMPA also allows registrants to submit a single Report covering multiple certificates under the following conditions:

• A single Report for multiple product certificates can be accepted by NMPA in case the multiple product certificates are issued for products with different specifications of the same medical device.
  → Ex: Single-use sterile syringes with different dimensions/specifications.
• Or in case the multiple product certificates have been issued for different products intended to be used in combination.
  → Ex: Artificial hip joints, including the acetabular cups and the femoral components that work as a system and that have been registered separately. 

Reference: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200702155401886.html