China: Acceptance of Foreign Generated Test Reports

ARQon
May 6, 2022
2 min read

In October of 2021, the National Medical Product Administration (NMPA) of China announced the “Provision for Self-Testing in Medical Device Registration”. This new regulation states that manufacturers can now use test results that have been generated overseas for medical device registration in China. Not only does this change make is easier, cheaper and faster for overseas companies to register their devices, it also frees up testing labs in China, making lab testing more efficient for domestic manufacturers. While it is true that the NMPA’s standards for what is considered acceptable results for the lab testing is high, this new regulation gives manufacturers new options for entering the China market.

More specifically, manufacturers can now choose among:

1. Conducting local testing in China 2. Improving their Quality Management System to meet self-inspection capability requirements 3. Using contracted manufacturer’s self-test reports 4. Conducting tests at an accredited lab

Foreign accredited labs

As mentioned above, manufacturers may opt to use foreign accredited labs to conduct their testing to avoid testing in China. Do note that currently only government laboratories are accepted by the NMPA, however, new guidance documents regarding this may be released in the future.

Manufacturers conducting in-house testing

Manufacturers can now also opt to submit in-house testing results for the application. However, note that since the tests are not conducted in a government accredited lab, these results would be under much greater scrutiny by the NMPA. Manufacturers opting for this route would need to show that all testing procedures meet appropriate standards and are incorporated into their Quality Management System (QMS), are conducted by qualified personnel in appropriate facilities, and all records are kept.

Document requirements

Naturally, manufacturers would also need to submit documents to prove to the NMPA that their requirements have been met. These include:

1. Self-test report if conducted in-house by manufacturer, or qualifications of the lab if outsourced 2. Statement of Qualification to state the testing facility is qualified to conduct testing. (Not required for accredited laboratories) 3. QMS documents 4. Model coverage, including description and analysis of model and configurations 5. Statement of self-guarantee for the authenticity of the report

These requirements are for the NMPA to ensure the manufacturers are truly qualified in conducting self-inspection work.

Sources:

Provisions on Self-inspection Management for Medical Device Registration Released and Implemented