With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.

The type testing of medical devices is required to determine whether a medical device meets the NMPA registration standards. Before order 739, all imported products were required to perform type testing of their medical devices in NMPA-accredited laboratories in China. Under Order 739, foreign manufacturers are allowed to submit a self-test report or hire a licensed medical device testing facility to conduct the tests and issue a testing report.

Foreign manufacturers wishing to import medical devices in China have the following two options to perform medical device type testing:

  • Perform the entire device type testing in China at NMPA-certified labs
  • Perform entire device type testing at qualified in-house laboratories

Highlights of the Self-Testing Provision

Self-Testing Capability Requirements

The capability to perform a self-test is determined by the availability and qualifications of testing personnel, equipment used for testing, the environment in which the testing is carried out, the established procedures for sample control, quality control, record control, etc. The self-testing protocol must be incorporated into the medical device QMS.  Applicants must create QMS documentation (such as quality manuals, operating instructions, and procedures) and risk management documents.

Commissioned Inspection Requirements

As per the self-testing provision, if the applicants cannot perform specific testing items at their laboratories, they can entrust the tests to a qualified medical device testing lab. However, it should be an NMPA-certified lab in China.

Submission Data Requirement under Self-Testing Provision

The applicants availing of the self-testing provision must submit the following:

  • Testing report
  • Relevant QMS information
  • Statement of authenticity

On-site Inspection Requirements

The NMPA conducts an on-site audit of the testing facility from where the self-testing is conducted. The NMPA must appoint a qualified inspector in accordance with the medical device registration QMS and “Self-inspection Capability Requirements” for performing the on-site audit.

Responsibility Requirements

Applicants must ensure that they are submitting an authentic report. If the testing (self-testing) report provided by the applicant is falsified, the applicant is liable to a penalty under Article 83 of order 739.

The changes adopted by NMPA are expected to ease the device registration process for foreign manufacturers. Manufacturers willing to market their devices in China must thoroughly evaluate this pathway, understand the requirements, and plan their Regulatory submissions accordingly.

To decode more about medical device type testing in China, reach out to our Regulatory expert today!

 

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