Legal analysis: do medical devices need to apply for relevant documents, sales of medical devices need to apply for sales-related qualifications, such as the sales of Class II devices for the record vouchers, the production of medical devices need to apply for a production license or production record vouchers. Engaged in the production of Class I medical devices, by the production enterprise to the location of the municipal people's government food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 20 of the Ordinance to prove the information. Engaged in the production of Class II, Class III medical devices, the manufacturer shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government Food and Drug Administration to apply for production licenses and submit its compliance with the conditions set out in Article 20 of the Ordinance to prove that information and the production of medical devices, the registration certificate. Engaged in the second class of medical devices business, by the business enterprise to the municipal people's government of the region where the food and drug supervision and management department for the record and submit it to meet the conditions of Article 29 of these Regulations. Engaged in the third class of medical devices business, the business enterprise shall be located in the municipal people's government food and drug supervision and management department to apply for business license and submit its conditions in accordance with the provisions of Article 29 of these Regulations to prove information.
Legal basis: "Chinese People's **** and the State Medical Device Supervision and Administration Regulations"
Article 21 has been registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, methods of use, etc., substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall apply to the original registration department to apply for a change of Registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.
Article 22 The registration of medical devices is valid for five years. The expiration of the validity of the need to renew the registration, shall be valid for six months before the expiration of the original registration department to apply for renewal of registration.