Legal analysis: do medical devices need to apply for relevant documents, sales of medical devices need to apply for sales-related qualifications, such as Class II device sales filing vouchers, the production of medical devices need to apply for a production license or production filing 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 the 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 its compliance with the conditions set out in 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 permission to operate and submit its conditions in line with the provisions of Article 29 of these Regulations.
Legal basis: "Supervision and Administration of Medical Devices Regulations"
Article 21 has been registered in the second class, the third class of medical device products, its design, raw materials, production processes, scope of application, use of methods and other substantial changes that are likely to affect the safety of the medical device, effective, the registrant should be registered to the original registration department to apply for a change in the registration formalities; other changes occurring Of, shall 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.
Article 30 engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (c) there is a guarantee of the quality of medical devices, management system; (d) with the production of medical devices compatible with the management system; (e) with the production of medical devices compatible with the quality of medical equipment, management system; (f) with the production of medical devices compatible with the production of medical devices. (D) with the production of medical devices compatible with the after-sales service capacity; (E) in line with the product development, production process documentation requirements.
Article 31 engaged in the production of Class I medical devices, shall be located in the municipal people's government responsible for drug supervision and management of the department for the record, in accordance with the conditions of Article 30 of these Regulations submitted to the relevant information is completed after the record. Medical device filers to produce their own Class I medical devices, in accordance with the provisions of Article XV of these regulations for the product record and submit the conditions in accordance with Article 30 of these regulations, that is, the completion of the production of the record.