What does the quasi-font size of medical devices mean?

The quasi-brand name of medical devices refers to the legal identity card of medical device products. ?

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to approve their sale and use.

Divided into domestic medical device registration and overseas medical device registration. Overseas medical devices, whether Class I, Class II or Class III, must be handled by the State Food and Drug Administration of Beijing; domestic medical devices of Class I and Class II shall be handled by the local provincial or municipal food and drug administration, and medical devices of Class III shall be handled by the State Food and Drug Administration.

Extended data:

Certificate number code:

The medical device registration number consists of six parts, basically arranged as: X(X) 1 US Food and Drug Administration (X2) XXXX3No. X4XX5XXXX6。

Among them, X 1 is the abbreviation of the location of the registration examination and approval department. Class III medical devices in China, overseas medical devices and medical devices in Taiwan Province Province, Hongkong and Macau are designated as "China".

The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the Central Government where the registration examination and approval departments are located. The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the registration examination and approval department is located plus the abbreviation of the municipal administrative region with districts.

For XX 1, there is no corresponding municipal administrative region with districts? It is just the abbreviation of provinces, autonomous regions and municipalities directly under the central government. Is X2 a registration form? (accurate, progressive and promising). The word "quasi" is applicable to domestic medical devices, the word "gold" is applicable to overseas medical devices, and the word "Xu" is applicable to medical devices in Taiwan Province Province, Hongkong and Macao.

XXXX3 is the year of registration approval, X4 is the product management category, and XX5 is the product variety code. XXXX6 is the registered serial number.

20 14 10 1, the new version of the measures for the administration of medical device registration came into effect, and the measures for the administration of medical device registration promulgated on August 9, 2004 (the former order of the US Food and Drug AdministrationNo. 16) was abolished at the same time. The new version of "Administrative Measures for Medical Device Registration" redefines the writing method of certificate number:

The registration certificate number is arranged as follows:

× 1 mechanical injection× 2×××××××× 3×××××× 6. These include:

× 1 is the abbreviation of the location of the registration examination and approval department:

Domestic Class III medical devices and imported Class II and Class III medical devices use the word "country";

The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the central government where the registration and approval departments are located;

×2 is the registration form:

The word "quasi" is suitable for domestic medical devices;

The word "gold" is applicable to imported medical devices;

The word "Xu" is applicable to medical devices in Hongkong, Macau and Taiwan Province.

××××× 3 is the year of first registration;

×4 is the product management category;

××5 is the product classification code;

××××× 6 is the first registered serial number.

Continue to register, keep the number of ××××××× 3 and ×××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× If the product management category is adjusted, it should be renumbered.

The number of the first class medical device registration certificate is arranged as follows:

× 1 mechanical equipment××××××× 2××××× 3.

These include:

X1is the abbreviation of the place where the filing department is located:

The first category of imported medical devices is the word "country";

The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the filing department is located plus the abbreviation of the municipal administrative region (there is no corresponding municipal administrative region with districts, but only the abbreviation of the province, autonomous region and municipality directly under the central government);

××××2 is the year of filing;

×××××× 3 is the serial number for filing.

References:

Baidu Encyclopedia: Measures for the Administration of Medical Device Registration