Annual (self-examination) quality management system report of medical device

Background of annual quality management report

Unlike some countries renewal report of quality management system is essential every 3 or 5 years, Chinese annual (self-examination) quality management report was born in 2022, required by NMPA, valid as of 2023.

Self-examination in translation of the name of report. It dosent hide that you have a special internal audit with special Chinese requirements. Besides typical activities as adverse event -, recall - and periodic risk evaluation report (PRER), it is a new action for every legal manufacturer in and outside China to submit annually QM report till end of March.

Summary of Chinese annual quality management report

Actually Chinese authority is eager to increase factory inspection overseas. Due to covid it is rare especially for overseas manufacturers. It is no wonder that an annual QM self-examination report is an obligatory action now so Chinese authority can have a monitoring of foreign manufactures in terms of key performance indicator of quality management system after product approval in China.

KPI is indeed a key word in the provided template of Chinese annual QM report. There are basic KPI-numbers to fill in given template by authority. The details of quality system indicators can be described in annex. So it is not complex and time consuming if

• Manufacturers know your Chinese products on certificate well
• All Chinese data can be easily filtered with help of CRM system
• Manufacturer have a smooth communication in relationship with Chinese distributor and Chinese agent and if hopefully post market work instructions exist.

So there are 8 chapters for manufacturers in main template and 8 annexes:

• Basic info
• Design and QM Change assessment
• Post market surveillance
• Adverse event and periodic risk evaluation report
• Sample inspection
• Centralized procurement
• Punishment (penality) in China
• Internal audit and management review

Lessons learned due to QM annual report in China

1. It is worthy to have a process of annual QM report for Chinese market and even of post market surveillance (after approval activities).
2. It is time to extend or update change assessment in own process at legal manufacturer with some Chinese elements.
3. It is finally to know what is critical- and key process in manufacturing workflow.
4. To collect data every year easily, it is better to take account into sales number of in China approved medical device, punishment, sample inspection, number of centralized procurement in China, number and details of customer complaint, adverse event, recalls, PRER, non-conforming products, inspection in and outside home country.
5. A new check list to audit your Chinese agent and Chinese distributor

Do you know that annual quality management report in China

• Has no certificate after approval
• Has no impact on valid product certificates (non stop of sales if deficiency is ongoing to reply)
• Need support from complaint, quality management, sales, Chinese distributor

In Professional service we guarantee that you pass the final review at authority. We will accompany the internal delegation of task internallys and communication with your Chinese distributor or Chinese agent.