Medical devices do not have approval numbers, only registration numbers.
The registration certificate number is organized as follows:
×1Mechanical Note×2××××3×4××5××××6. Among them:
×1 is 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, 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. If the product management category is adjusted, it should be renumbered.
The first class of medical devices for the record voucher number is organized as follows:
×1Mechanical preparation ××××2××××3 number.
Where:
×1 for the record of the department of the location of the abbreviation:
Imported Class I medical devices for the "country";
International Class I medical devices for the record of the department of the location of the province, autonomous region, municipalities 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 (no). 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.
Extended information:
One, two or three types of medical devices are classified according to the safety of their use:
1, a class of
It refers to the routine management of the medical device is sufficient to ensure the safety and efficacy of the device. Generally by the City Food and Drug Administration to approve the registration certificate issued. Its operation can not use the "Medical Device License", only need to register to the Trade and Industry Bureau.
For example: external hemostatic patch. It should be noted that not all "hemostatic patch" is a class, some are Class II medical devices, some are chemical drugs, these products have to be based on the nature of its own decision.
2, Class II
is that, on its safety, effectiveness should be controlled medical devices. Generally by the provincial Food and Drug Administration to approve the registration certificate issued. For example: thermometer, sphygmomanometer, condoms (condoms) and so on.
The state has been out of two batches do not need to apply for "medical equipment business license" of the second class of medical devices, the first batch of thirteen, the products are: thermometers, sphygmomanometers, medical skimming cotton, medical skimming gauze, medical sanitary masks, magnetic therapy devices, home blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test side of the test strips), condoms, condoms, wheelchairs, wheelchairs, medical sterile gauze;
What's more, it is not necessary to apply for "medical device business license" of the second class of medical devices. Gauze;
The second batch does not need to apply for a "medical device business license" of six products: electronic blood pressure pulse meter, plum blossom needles, pronged needles, acupuncture needles, ovulation detection test strips, hand-held oxygen generator.
3, Class III
It refers to, implanted in the body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Generally by the State Food and Drug Administration to approve, issue a registration certificate.
Reference: