1, personnel
(1) Full-time quality management personnel of medical device enterprises of category III shall have college degree or above or intermediate title or above.
(2) No less than RMB 6,543,800,000.00 Yuan for Class III medical device enterprises.
(3) The quality inspectors of the third category medical device enterprises should have a college degree or above or an intermediate title or above.
(4) Enterprises engaged in the retail of domestic therapeutic products or three types of implanted devices should be equipped with personnel with certain medical qualifications.
2. Commercial premises
(1) business premises: the general business area is not less than 40 square meters, and the residence cannot be used as the business premises of the enterprise; Retail enterprises must be facade houses.
(2) Storage conditions: the general commercial use area is not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises.
(3) Enterprises engaged in disposable aseptic, implantable and other special medical devices must have their own warehouses, and the storage conditions should meet the requirements of product standards.
How to apply for a medical device business license
1, materials needed for processing
(1) enterprise name and business scope, registered capital, shareholder's contribution ratio and shareholder's identity certificate;
(2) Medical device product registration certificate, supplier's business license, license and power of attorney;
(3) Quality management documents, etc.
(4) Certificates, identity certificates and resumes of two or more medical professionals or related professionals;
(five) proof that the office space and warehouse meet the requirements of medical device management;
(6) Articles of Association, resolutions of shareholders' meeting, etc. ;
(7) Other relevant materials.
2. It is qualified.
(1) There are quality management institutions or full-time quality management personnel suitable for the scale and scope of business. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) Having a relatively independent business place suitable for its business scale and business scope;
(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
(4) The product quality management system should be established and improved, including procurement, incoming goods acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system.
(5) Having the technical training and after-sales service capabilities suitable for the medical device products it deals in, or agreeing to provide technical support by a third party.
3, handle the required process
(1) Submit the application and related materials. The drug supervision department shall examine whether the application materials meet the basic requirements and decide whether to accept them.
(2) On-site audit. The drug supervision department shall assign one to three auditors to audit the business site of the enterprise. Do not meet the requirements, you can ask the enterprise to carry out rectification. If the rectification still does not meet the requirements, a notice of disapproval shall be given.
(3) issue certificates. The drug supervision department decides whether to issue a business license to the enterprise according to the relevant information, and publicizes the relevant information of the enterprise on the relevant website. If there is no objection after publicity, the enterprise will be notified to obtain the medical device business license.
Validity period of medical device business license
The validity period is 5 years. Indicate the license number, enterprise name, legal representative, person in charge of the enterprise, domicile, business premises, mode of operation, business scope, warehouse address, issuing department, issuing date and effective period, etc. The Medical Device Business Registration Certificate shall specify the number, enterprise name, legal representative, person in charge of the enterprise, domicile, business premises, business mode, business scope, warehouse address, filing department, filing date and other matters.
Medical device management filing process
Enterprises that have obtained the Medical Device Business License shall fill in the Record Form of Class II Medical Device Business in the medical device production and business license (record) information system when applying for class II medical device business record. After printing the Record Form for the Operation of Class II Medical Devices, the enterprise shall affix its official seal to the municipal food and drug supervision and administration department located in the district for the record. The food and drug supervision and administration department shall check the integrity of the information submitted by the enterprise on the spot, put it on record if it meets the requirements, and issue a record certificate for the operation of Class II medical devices.
At the same time, enterprises that apply for the business license of Class III medical devices and handle the business record of Class II medical devices shall submit two sets of paper materials and upload two electronic documents online. Optimization is to submit paper materials 1 set of three types of medical device business licenses, and upload electronic documents 1 copy online. For the record-keeping of Class II medical devices, only the Record-keeping Form for Class II medical devices needs to be filled in the medical device production and operation license (record-keeping) information system. After printing the Record Form for the Operation of Class II Medical Devices, the enterprise shall apply to the municipal food and drug supervision and administration department with the official seal and the application materials for Class III business license. The food and drug supervision and administration department may complete the on-site inspection of the business license of Class III medical devices together with the on-site inspection of the business record of Class II medical devices.