Medical device registration form is just to register a brief enterprise information, in order to most filing with.
The medical device registration certificate is proof that the product has met the relevant national certifications and approvals. It can be formally sold.
Introduction:
Medical device registration, refers to the legal process, the proposed market sales, the use of medical devices to the safety, effectiveness of the systematic evaluation, in order to decide whether to agree with its sales, the use of the process. It is divided into domestic medical device registration and overseas medical device registration, overseas medical devices whether it is a class, class II, class III to the State Food and Drug Administration in Beijing for: domestic class I, class II medical devices in the local provincial or municipal food and drug supervision bureau for, class III to the State Food and Drug Administration for. The medical device registration certificate refers to the legal identity card of the medical machinery products.
Classification:
Class I
means, medical devices whose safety and effectiveness are sufficiently ensured through routine management. Generally by the Municipal Food and Drug Administration to approve, issued by the registration certificate. 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 paste" is a class, some are Class II medical devices, some are chemical drugs, these have to be based on the nature of the product itself.
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 come out of two batches do not need to apply for "medical device business license" of the second class of medical devices, the first batch of thirteen, the products are: thermometers, sphygmomanometers, medical degreasing cotton, medical degreasing 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 test strips), condoms, condoms, wheelchairs, wheelchairs, medical sterile gauze. The second batch [2]? Do not need to apply for a "medical device business license" of six products: electronic blood pressure pulse meter, plum blossom needles, trigonometry, acupuncture needles, ovulation detection test strips, portable oxygen generator.
Class III
It refers to, implanted in the human 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, issued by the registration certificate.
But the bottom of the approval of a medical device is classified into several categories of the side is not a lifetime, is determined by its safety, the State Bureau has the right to change its classification, such as masks in general are divided into a class of the period, but in the period of SARS was classified as a class of two!