Medical device registration certificate format by the State Food and Drug Administration unified development. Registration certificate number is arranged as follows: × 1 mechanical note × 2 ××××3 × 4 × × 5 ××××6.
1, × 1 for the registration and approval of the department of the location of the abbreviation: the territory of the third class of medical devices, imports of Class II, Class III medical devices for the "country"; the territory of the second class of medical devices For the registration and approval department of the location of provinces, autonomous regions and municipalities directly under the Central Government abbreviation.
2, × 2 for the form of registration: "quasi" word applies to the domestic medical devices; "into" word applies to imported medical devices; "Xu" word applies to Hong Kong, Macao, Taiwan's medical devices;
3, ××××3 for the first registration year.
4, × 4 for the product management category.
5, × × 5 is the product classification code.
6. ××××6 is the first registration running number.
7, the continuation of registration, ××××3 and ××××6 figures remain unchanged. Product management category adjustment, should be renumbered.
Medical device registration certificate number is a medical device product in the state food and drug supervision and management department or similar institutions after the registration of the unique number. The specific arrangement may vary from country to country and region to region, you can refer to the relevant regulations of the local food and drug regulatory authorities or consult professionals for accurate information. The medical device registration certificate number is a sign of the legal compliance of medical device products, and is important for market access, safety supervision and protection of users' rights and interests.
This number has an important role in the medical device industry in which aspects
1, legal compliance verification: medical device registration number is an important basis for verifying the legal compliance of medical device products. Only get the registration certificate of the device products can be legal sales and use, can avoid illegal, fake and shoddy medical devices into the market, to protect the public's safety and rights.
2, market access requirements: medical device registration certificate number is one of the important conditions of market access. The laws and regulations of many countries and regions require that all medical device products sold must obtain a registration certificate and mark the corresponding registration certificate number on the product to ensure that the product meets the safety, effectiveness and other requirements to protect the rights and interests of users.
3, product traceability and tracking: Through the medical device registration certificate number, you can realize the traceability and tracking of medical device products. Once product quality problems, safety hazards or recalls are found, they can be traced back to specific product batches and manufacturing companies, and corresponding measures can be taken to ensure the safety of public medication.
4, information query and supervision: medical device registration certificate number as a unique identification of medical device products, can be used for information query and supervision. Relevant departments can query and obtain detailed information of the product according to the registration number to understand the scope of the product, applicable performance, etc., in order to carry out supervision and management.