The medical device registration number is organized as follows: ×1 food and drug supervision and regulation of mechanical (×2) word ××××3 No. ×4 × ×5 ××××6. Which × 1 for the abbreviation of the location of the registration and approval department, (× 2) for the form of registration, quasi for the territory of the medical device, into the word for overseas medical devices, Xu word for Hong Kong, Macao and Taiwan medical devices. ××××3 for the approval of the year of registration, × 4 for the product management category, × × 5 for the product variety code (operating room, emergency room, diagnostic and treatment room equipment and appliances, medical hygiene materials and dressings), ××××6 for the registration of the water number.
For example, the Guangdong Food and Drug Administration, armament (quasi) word 2007 No. 2540047, the first Yue word for the abbreviation of Guangdong Province, quasi-representative of the quasi in parentheses for the domestic production of the territory for the approval of the registration of the year 2007, followed by the number of 254 on behalf of medical high-frequency equipment, 0047 for the registration of the sequential running number. Purchase and use of medical equipment, to recognize the registration number, some approved registration number for the word of insurance, is a health care products, not medical equipment, be careful to distinguish.
Expanded information:
Note:
The products declared for registration have been included in the "Classification Catalog of Medical Devices" and the management category of the second class. (For newly developed medical devices not yet included in the Classification Catalog, the applicant can apply directly to the State Food and Drug Administration for registration of Class III medical device products, or apply for product registration or for product filing after judging the product category based on the classification rules and applying to the State Food and Drug Administration for category confirmation.)
The applicant shall be an enterprise registered in each provincial jurisdiction according to law.
The applicant establishes a quality management system related to product development and production, and maintains effective operation. Samples shall not be entrusted to other enterprises to produce when applying for registration, except for products approved in accordance with the special approval procedures for innovative medical devices.
Baidu Encyclopedia-Medical Device Registration Certificate