The plaster class "Yixie" qualitative and regulatory
Phenomenon of fake and shoddy products appear in the form of a plaster class medical devices such as motion sickness stickers insect paste, cooling paste, paste lumbar pain, anti-inflammatory paste, approval lax, any exaggerated the scope of application, record have appeared. Number and wide variety, circulation and use of multi-drug retail enterprises or clinic, supply mail order or home delivery. Violations are mainly three kinds:
1. Theft or fabricate medical device product registration card number. Such medical devices the SFDA or provinces Bureau database will immediately betray oneself. But the actual check, the check varieties range, it is not possible for each product are entered into a database query, so mastering the law of medical device product registration number choreography, management categories and the product varieties coding important.
2 drug approval as medical devices. SFDA Medical Device combination products registered the matter Notice (Notice No. 16 of 2009) in the clear "based pharmaceuticals role, Medical Device combination products, required to declare the Drug Registration; based medical devices role 药械 combination products need to declare the registration of medical devices ... with drug-eluting stents, catheters with antimicrobial coating drug-containing condoms containing drug products IUD register management, medical devices, containing anti-bacterial, anti-inflammatory drugs wound paste, Chinese herb sticking products registered medicines management. "But the market a lot of bandage containing anti-bacterial, anti-inflammatory drugs, Chinese herb sticking products are a class of medical devices for examination and approval.
3 high-class low batch or non-the equipment approval as instruments. Class II Medical Device approval for a class of medical devices to the examination and approval department prefectural or municipal level by the provincial Bureau to Bureau easier access to the medical device registration certificate, but this makes the lawbreakers. This does not belong to the medical devices approval as medical devices, to improve the surface quality of product management, in fact in order to facilitate treatment of diseases marked on the product content.
To root out the source case found clues
Product registration number. The inspectors should be familiar with the medical equipment Wen No. the choreography law, the category of product management and product varieties coding. Different periods of medical equipment symbol choreography law is not the same as the August 2004 new medical devices registered management approach (Board Order No. 16) come into force. The organized registration number 2004:
× (×) 1 (Fresh) armed Drug Administration (× 2) word × × × × 3 × 4 × × × × × × 6
× 1 is referred to as the registered location of the examination and approval department: domestic Class III medical devices, outside medical equipment and medical devices in China, Taiwan, Hong Kong, Macau is the word "country"; registered within the Class II medical devices for the examination and approval department where the provinces, autonomous regions and municipalities directly under the Central Government referred; within the first category of medical devices for the registration examination and approval department where the provinces, autonomous regions and municipalities directly under the Central Government referred plus where the municipal districts administrative regions referred × × 1 (no corresponding set municipal administrative regions, provinces, autonomous regions, municipalities directly under the Central Government, only referred to).
× 2 registered form (quasi-Jin, Xu): the word "quasi" applicable in the territory of medical devices; "into" word applies to offshore medical devices; "Xu" the word applies to Taiwan, Hong Kong, Macau's medical devices; generally do not have the word "trial", but there are exceptions, such as in the transition period, the Food and Drug Administration accepted, the Food and Drug Administration for approval, can the word "trial" appears.
× × × × 3 for the approval of the registration Year; × 4 category of product management; × × 5 encoded product variety; × × × × 6 registration serial number.
View product performance standards. Medical equipment standard management approach "(Trial) (Board Order No. 31) Article III:" The medical device standards into national standards, industry standards, and the registered product standards. (A) national standards or industry standards nationwide unified technical requirements of the standard.