1, personnel
(1) Class III medical device business enterprise quality full-time management personnel should have college education or intermediate title.
(2) Class III medical device business enterprises not less than 1 million yuan.
(3) The third class of medical devices business enterprise quality inspection personnel should have college education or above or intermediate or above title.
(4) Business involving the retail sale of household therapeutic products or Class III implantable devices should be equipped with certain medical and technical qualifications.
2, business premises
(1) business premises: general business area of not less than 40 square meters, residential buildings can not be used as business premises; retail business enterprises must be front rooms.
(2) storage conditions: general business use area of not less than 20 square meters, residential buildings can not be used as a business storage space.
(3) the operation of one-time use of sterile, implantable and other special medical device products, enterprises must have their own management of the warehouse, warehousing conditions should be in line with the requirements of the provisions of the product standards.
How to apply for a medical device license
1, for the required materials
(1) business name and scope of business, registered capital and shareholders' contribution ratio, shareholders and other identification;
(2) medical device product registration certificate, supplier business license, permits and authorization;
(3) quality management documents;
(4) two or more medical or related professional certificates, identification and resume;
(5) meet the requirements of the medical device business office space and warehouse certificates;
(6) articles of incorporation, shareholders' meeting resolutions, etc.;
(7) other related materials.
2, for the conditions
(1) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;
(2) with the scale and scope of operation of relatively independent premises;
(3) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical equipment products;
(4) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(5) should have the appropriate technical training and after-sales service capacity with its medical device products, or agreed to provide technical support by a third party.
3, for the required process
(1) submit an application for processing and related materials. Pharmacovigilance department to check whether the application information meets the basic requirements, and decide whether to accept or reject the application decision.
(2) On-site audit. Pharmacovigilance department assigned one to three auditors to the business site audit, such as failure to meet the requirements of the enterprise can be asked to rectify, such as rectification still does not meet the requirements of the notice given by the non-licensing.
(3) Issuance of certificates. The drug supervision department according to the relevant information to decide whether to give the enterprise business license, and in the relevant website on the enterprise information for publicity, after the publicity of no objection to notify the enterprise to receive medical equipment business license.
Medical device license validity
Valid for 5 years. Contains the license number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, scope of business, warehouse address, the licensing department, the date of issuance and expiration date and other matters. Medical device business record certificate shall contain the number, enterprise name, legal representative, responsible person, residence, business premises, mode of operation, business scope, warehouse address, filing department, filing date and other matters.
Medical device business filing process
The "medical device business license" of the enterprise to apply for the second class of medical devices for the record, should be in the medical device production and operation licensing (for the record) information system to fill out the second class of medical devices business filing form. Enterprises print the second class of medical devices business filing form, stamped with the official seal to the location of the municipal food and drug supervision and management department for the record. Food and drug supervision and management departments should be on the spot on the integrity of the information submitted by the enterprise to check, in line with the provisions of the record to be filed, issued by the second class of medical equipment business record vouchers.
At the same time apply for the third class of medical devices business license and for the second class of medical devices for the record by the original enterprises to submit two sets of paper materials, the network to upload two electronic documents, optimized for the application of the third class of medical devices business license to submit a set of paper materials, the network to upload an electronic document for the second class of medical devices for the record only need to be in the medical device production and operation licensing (filing) Information system to fill in the second class of medical devices business filing form. Enterprises print the second class of medical devices business filing form, stamped with an official seal and the third class of business license application materials to the location of the municipal food and drug supervision and management department to apply. Food and drug supervision and management departments in the third class of medical equipment business license on-site inspection, can be completed together with the second class of medical equipment business filing on-site inspection.