After having released the notice concerning the submission of product periodic risk assessment reports, NMPA has proceeded by issuing a guidance which regulates and advises registrants on how to prepare the “Product Periodic Risk Assessment Report ” (hereafter called “Report”). Essentially, NMPA’s Report is similar in conception to the European “Periodic Safety Update Report (PSUR)”. Registrants are required to prepare the Report for all medical devices (including IVDs) listed in China. Most importantly the Report of Class II and Class III products shall be submitted to NMPA via NMPA’s online system. The Report of Class I products on the other hand shall be kept in registrants’ possession. Qualtech has studied this new guidance, and has made a summary as below:

1. Requirements for the Report Submission

Classification	Submission	Frequency
Class I	The Report will be retained by the registrant (product manufacturer).	The Report should be prepared annually for the first five years after the initial product approval and should only be submitted when required. Preparation of the annual Report will no longer be required after the first renewal of the certificate has been completed.
Class II & III	Online submission to NMPA	Cycle for Initial Registration: *1)  The registrant shall prepare the Report annually for the first five years after initial product approval. The Report shall be submitted online to NMPA within the time period of 60 calendar days before the approval date shown on the certificate every year. → Example: If the approval date on the product certificate is August 25th, 2020, then the first annual Report shall be submitted in the period of June 25th, 2021 to August 24th, 2021. Cycle for Renewed Certificates: *2) The registrant shall submit the Report before the renewal application of the certificate. The starting date of the Report shall be the last day of the previous reporting period, while the ending date shall be within 60 days prior to the next renewal application.

1. 1) The above “cycle for initial registration” applies to the period from the date of the initial approval to the submission date for the 1^st renewal application.
2. 2) The “cycle for renewed certificates” above entails the period after the 1^st successful renewal and afterwards.

2. Report Format

The Periodic Risk Assessment Report contains three parts: cover, table of contents, and the main contents.

2.1 The Cover includes the product name, approval date of the registration certificate, product certificate status (either Initial Registration or Renewed Certificate), the number of how many “Product Periodic Risk Assessment Reports” have already been submitted, the reporting period, domestic sales during this period, overseas sales during this period, the number of reported adverse events, the name and contact information of the authorized representative, department and person responsible for product safety, contact information (including mobile phone, landline phone, e-mail, etc.) of the registrant (product manufacturer), the report submission time, privacy protection, and other relevant information.

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

2.3 The Main content of the Report shall include 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.

3. Language Requirement

An overseas registrant of imported medical devices may submit the "Periodic Risk Assessment Report" in English, but a Chinese translation is required. Yet, the case report of individual adverse events can be written in English with no Chinese translations needed.

4. 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:

The Notice of NMPA on the publication of periodic risk evaluation reports for medical devices

 

RECOMMEND READING

China Registration Introduction CHINA: NMPA Published the Update Guidance of Adverse Event Monitoring for Medical Device – May, 2020