In recent years, China has become a burgeoning market for medical device manufacturers, presenting both vast opportunities and regulatory hurdles. As a large importer of medical devices, China is often on the short-list of target countries but the process for clearance can be overwhelming and unclear. Central to access for the China market is to having medical devices registered at the National Medical Products Administration (NMPA), the regulatory body responsible for overseeing medical devices' safety, efficacy, and quality in China. To successfully navigate the Chinese market, understanding the step-by-step process within the NMPA program is crucial.

In October 2021, the NMPA released its announcement No. 126 of 2021 – Regulations on the Self-Testing of NMPA Medical Device Registration. This was a significant win for the medical community. As a result, it is now acceptable for medical device applicants to submit a self-testing report for NMPA registration. The self-testing report can be from an applicant's internal test lab or from an CMA accredited third-party testing lab located in China.

As a third-party testing laboratory, we've seen manufacturers utilize the self-testing report for NMPA Medical Device Registration to their advantage. Following the step-by-step process below and leveraging the new Regulation, market entry to China may be more straight forward than you think!