China NMPA On-Site QMS Inspection for Domestic Medical Device Registration
Step 1Submit NMPA registration and receive acceptance
Step 2Submit request for inspection to local NMPA
Step 3Local NMPA perform onsite inspection
Three Possible Results
(2) Pass with Rectification
(3) Not Pass
Report to NMPA
Submit rectification report within 1 month
Re-inspection after at least 3 months
Key documents required for domestic registration submission
Product risk analysis information.
Product technical requirements.
Product type testing reports.
Clinical evaluation information.
Product specifications and sample labels.
Product development, production-related quality management system documents.
Other information to prove product safety and effectiveness.
Notes: The domestic registration can leverage the previous registration dossier used for the imported registration, which may shorten the timeline for submission dossier preparation and NMPA technical review.
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Answer: Medical device manufacturer or entrusted manufacturer needs to apply for a medical device production license when the NMPA registration certificate is obtained. The production license shall be applied through the provincial regulatory authority for medical devices.
Answer: As per the NMPA Guidance document issued in 2929 (No. 104, 2020), the summary review documents, research documents, clinical evaluation documents, and risk assessment documents from the previously imported registration dossier can be used for domestic registration.
Shanghai is the first province in China to implement the MAH system and is currently the region with a complete system in the country.
According to the "Implementation Plan for the Pilot Program of the MAH in the Yangtze River Delta Region", if you establish a MAH in Shanghai, it can entrust companies in the administrative regions of Shanghai, Jiangsu Province, Anhui Province, and Zhejiang Province to carry out medical device production.
In addition to the person in charge of the enterprise, there should be at least one person responsible for the quality system management (manager representative and quality person in charge), at least one regulatory affairs person (RA), and at least one post-marketing person (QA). The R&D process can be outsourced (Beijing and Shanghai have clear requirements). The product release process can be handled by the entrusted entity (as specified in the quality agreement), and the sales process can be entrusted to a suitable distribution company (in compliance with Good Supply Practices).