How to distinguish between a class of medical devices and other medical devices filing number

The registration certificate numbering method is different, a class is 械备, on behalf of the record. The second and third category is 械注, on behalf of the registration.

Article 76 The format of the medical device registration certificate is formulated by the State Food and Drug Administration.

The registration certificate number is organized as follows:

×1械注×2××××3×4××5××××6。其中：

×1 for the abbreviation of the location of the registration and approval department：

international Class III medical devices, imports of Class II and Class III medical devices for the "national "

Domestic Class II medical devices for the abbreviation of the province, autonomous region and municipality directly under the Central Government where the registration and approval department is located;

×2 for the form of registration:

"Quasi" applies to domestic medical devices;

The word "import" applies to imported medical devices;

The word "permit" applies to medical devices in Hong Kong, Macao and Taiwan;

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

×4 is the product management category;< /p>

××5 is the product classification code;

××××6 is the first registration running number.

For continuation of registration, the numbers of ××××3 and ××××6 remain unchanged. Product management category adjustment, should be renumbered.

Article 77 of the first class of medical devices for the record voucher numbering is organized as follows:

×1Mechanical preparation ××××2××××3 number.

Where:

×1 for the filing of the department of the location of the abbreviation:

Imported Class I medical devices for the "country";

International Class I medical devices for the filing of the department of the location of the province, autonomous region, municipality directly under the Central Government for the abbreviation of the location of the municipal administrative region plus the abbreviation of the municipal administrative region of the region (none). When the corresponding municipal administrative region, only the province, autonomous region, municipality directly under the Central Government for the abbreviation);

××××2 for the record year;

××××3 for the record running number.

Expanded Information: