Type testing, also known as conformance testing, is a mandatory requirement by the National Medical Product Administration (NMPA), for market approval of medical devices.
Type testing involves activities that determine whether a medical device complies with the requirements of specifications, Chinese technical standards, or regulations. As per NMPA requirements, the manufacture (as applicant of product registration) needs to establish 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 product to be registered, etc. The PTR is also part of the registration certificate and needs to be appropriately maintained by the manufacturer.
Starting from June 2021, China has introduced the newly updated regulation of medical devices – Decree739 issued by the State Council — Officially named as “Regulations on the Supervision and Administration of Medical Devices.” Before Decree 739, medical device manufacturers must perform type testing and obtain the testing report at NMPA accredited laboratories in China. One of the significant changes of Decree 739 is allowing manufacturers to submit a self-test report or entrust a qualified laboratory to perform the tests and issue a testing report.
On October 22nd, 2021, based on Decree 739, the NMPA issued the Management Provision on the Self-Testing for Medical Device Registration (“The Provision”). This Provision is divided into six parts, including:
- 1. Capability of self-testing
- 2. Requirments for self-testing report
- 3. Requirments for subcontracting the type testing to the qualified laboratory
- 4. Requirements for submission dossier
- 5. Requirments for on-site inspection by NMPA
- 6. Responsibility of applicant
Highlights of the Self-Testing Provision
(1) Develop related Quality management System (QMS) Documents
The capability of performing self-test involves the requirements of testing personnel, equipment and environment, control of testing articles, quality control, and record control, etc. Most importantly, the self-test work should be incorporated into the medical device QMS. The manufacturer should develop QMS documents (including quality manuals, procedures, operating instructions, etc.), risk management documents, and medical device-related regulatory documents related to self-testing.
(2) Self-testing at the manufacturer’s laboratory
- The registration applicant’s laboratories where the type testing is performed shall have specific qualifications including the capability of self-testing and Quality Management System. If the laboratory of the domestic manufacturer is accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or the laboratory of the overseas manufacturer is accredited by the foreign government or the corresponding laboratory accreditation agency recognized by the government , It is not necessary to submit the documents related to capability of self-testing and QMS , but the corresponding certification documents and supporting materials for the corresponding testing scope shall be provided.
(3) Subcontracting the type testing to the qualified laboratory
As per the Self-testing Provision, if the manufacturer cannot perform specific testing items at its laboratories, they can entrust the tests to a qualified medical device testing laboratories. However, the qualification of the testing laboratories shall comply with Article No. 75 of Decree 739, which specifies the third party laboratories shall be accredited by NMPA..
(4) On-site inspection
For the manufacturer who submit the self-testing reports for product registration, while NMPA conducts the on-site inspections of the QMS, NMPA shall not only follow the requirements of QMS verification guidelines for medical devices but also follow the “Capability of self-testing” stated in the first section of The Provision.
(5) Liability requirements
If the self-testing report provided by the manufacturer is false, it shall be punished per Article 83 of Decree 739. If the entrusted laboratory issues a false report, it shall be punished per Article 96 of Order 739.
In summary, foreign manufacturers for medical devices now have three options to perform the type testing for product registration with NMPA in China:
- 1. Perform the entire type testing in China at NMPA accredited laboratories.
- 2. Perform the entire type testing at your own laboratories that is certified by your home country’s regulatory body per GLP requirements.
- 3. Perform some testing items at your own lab that is certified by your home country’s regulatory body per GLP requirements and entrust NMPA accredited laboratories in China to perform the tests that are out of your capabilities.
Regulations on the Administration of Self-test of Medical Device Registration