Medical device product registration standards are submitted to the provincial or national drug administration for the registration of medical devices, and are used throughout the registration process (e.g., product testing, animal/clinical trials, enterprise quality system assessment, etc.).
The product registration standard can be a national standard, but also can be the standard or enterprise standard.
Currently in Beijing, the enterprise standard by the Beijing Municipal Bureau of Drug Administration audit and filing as a registered standard used (the specific case is in accordance with the Q word submitted enterprise standard, through the audit and filing, issued to the YZB word registration standard number), and in other provinces and the National Bureau of the current implementation of the enterprise standard has not been reviewed for the record, accordingly to the enterprise registration materials submitted to the standard as the registration standard. .