In order to strengthen the supervision and management of medical devices post-market surveillance, NMPA has revised the "The Quality Inspection Measures of Medical Device" (hereinafter as the "Measures"). The original "The Quality Inspection Measures of Medical Device " document was issued by NMPA when it was formerly known as CFDA (No. 212 in 2013) and "National Medical Device Sampling Inspection and Inspection Procedures" (No. 213 in 2014) were abolished at the same time.
The revised "Measures" are specifically divided into seven major chapters: general rules, planning protocol, inspection sampling, inspection management and report delivery, re-inspection action, supervision and management, and supplementary provisions.
The concept of this revision is to clarify the obligation and requirements of NMPA, registrants and inspected firm, while aiming to discover systemic risks of medical device safety in time and eliminate hazards of medical devices. Registrant and filing establishment of imported medical device shall designate legal person of an enterprise within the territory of China, as an agent to cooperate with the random inspection of imported medical device.
The medical device registrant and the sample units shall fulfill the following obligations after learning that the product has failed during official inspection:
- Implement product recall and stop release to public;
- Immediately conduct self-inspection and risk assessment on the product;
- Take necessary risk control measures regarding the evaluation result.