NMPA focuses on inspections of sterile and implantable medical devices
The NMPA published Announcement No. 34 of 2020 on April 14 in order to reinforce the supervision and inspection of sterile and implantable medical device companies in China, in conjunction with the prevention and control of COVID-19. Notably, these companies must complete and submit the relevant self-inspection forms (provided as attachments to the announcement) before the end of June.
According to the announcement, inspections will focus on "high-value medical consumables," devices used for the prevention and control of novel coronavirus epidemics (especially medical protective clothing, masks, and other large-scale products), single-use infusion equipment, etc. There will also be a focus on companies with multiple years of random sampling failures or serious defects in previous inspections; those who lack the appropriate certifications or training; those who fail to meet requirements for self-inspection; or any other companies for which serious security risks are identified. The announcement also outlines the key points to be verified in an inspection.
Provisions for documents that cannot be notarized
China’s Center for Medical Device Evaluation (CMDE) has issued Notice No. 13 of 2020, specifying arrangements for the submission of notarized documents, due to lockdowns and/or remote office arrangements in other countries that may make them difficult to obtain. Documents for the registration, modification, and renewal of imported Class II and III medical devices (or IVD reagents), as well as clinical trial approval applications, that cannot be notarized may be temporarily submitted with a signature by the (foreign) applicant or manufacturer. The signature must be accompanied by an explanation for the absence of the notarized documents and a promise to bear the corresponding legal responsibility. Additionally, the notarized documents must be submitted as part of the supplementary materials requested during the application review process.
Learn more about China NMPA medical device regulatory issues at Emergo by UL:
- China NMPA medical device registration and approval consulting
- Medical device clinical and testing requirements assessment for China
- Process chart: NMPA regulatory approval for medical devices
- Whitepaper: China NMPA medical device registration
- Webinar: Medical device registration in China