Official NMPA Regulation Released: Self-Testing for Medical Device Registration in China
Fundamental of Type Testing
Type testing, also known as medical device registration testing, is a mandatory requirement by the National Medical Product Administration (NMPA), the equivalency of the FDA in China, for market approval of medical devices.
Type testing involves activities that determine whether a medical device complies with the requirements of specifications, technical standards, or regulations. As per NMPA requirements, the applicant needs to draft a Product Technical Requirements (PTR). The PTR serves as the protocol for the type testing, which contains the testing methods, performance indicators, and applicable technical standards for the proposed product, etc. The PTR is also part of the registration certificate and needs to be appropriately maintained by the manufacturer.
Order 739 Allows Self-Testing Report
Starting from June 2021, China enters the new era of medical device registration, with the implementation of the newly updated fundamental regulation of medical devices – Order 739 issued by the State Council — Officially named as “Regulations on the Supervision and Administration of Medical Devices.” Before Order 739, medical device manufacturers must perform type testing and obtain the testing report at NMPA certified laboratories in China. One of the significant changes of Order 739 allows manufacturers to submit a self-test report or commission a qualified medical device testing laboratory to perform the tests and issue a testing report, which is a major adjustment to medical device registration work requirements.
Release of Management Provision on the Self-Testing of Medical Device Registration
On October 22nd, 2021, based on the regulations in Order 739, the NMPA issued the Management Provision on the Self-Testing of Medical Device Registration (“The Provision”). This Provision is divided into six parts, including:
- Self-testing capability requirements
- Self-testing report requirements
- Commissioned testing requirements
- Submission dossier requirements
- On-site inspection requirements
- Liability requirements
Highlights of the Self-Testing Provision
1. Develop related QMS Documents
The capability of performing self-test involves the requirements of testing personnel, equipment and environment, sample control, quality control, and record control, etc. Most importantly, the self-test work should be incorporated into the medical device quality management system. Registration applicants should develop QMS documents (including quality manuals, procedures, operating instructions, etc.), risk management documents, and medical device-related regulatory documents.
2. Self-testing at the registration applicant’s laboratories
The registration applicant’s laboratories where the type testing is performed shall have specific qualifications. For example, suppose the lab is in China. In that case, it must be certified by the CNAS (China National Accreditation Service for Conformity Assessment) as per the Chinese equivalency of the Good Laboratory Practice. In the lab is outside China, it must obtain specific certification from the local regulatory body.
3. Commission testing
As per the Self-testing Provision, if the registration applicant cannot perform specific testing items at its laboratories, they can entrust the tests to a qualified medical device testing lab. However, the qualification of the testing laboratories shall comply with Article No. 75 of Order 739, which limits the qualification to NMPA certified laboratories. In summary, if the applicant wants to commission type testing to a third-party lab, that lab must be an NMPA certified lab in China.
4. On-site inspection
For registration applicants who submit a self-testing report, when conducting on-site inspections of the medical device registration quality management system, the NMPA shall not only follow the requirements of the relevant medical device registration quality management system verification guidelines but also follow the “Self-inspection Capability Requirements” in the first part of this Provision.
5. Liability requirements
If the self-testing report provided by the registration applicant is false, it shall be punished per Article 83 of Order 739. If the entrusted party issues a false report, it shall be penalized per Article 96 of Order 739.
Summary
Foreign medical device registration applicants now have three options for performing type testing for China approval:
- Perform the entire type testing in China at NMPA certified labs.
- Perform the entire type testing at your own lab that is certified by your home country’s regulatory body per GLP requirements.
- Perform some testing items at your own lab and entrust NMPA certified lab in China to perform the tests that are out of your capabilities.
No matter where you perform the tests, the key is to develop a PTR compliant to NMPA requirements and includes all the testing items and technical standards applicable to your products. Based on the PTR, BradyKnows (IMD) can help you develop a customized strategy to find out the best option for running type testing in an efficient and economical approach.
