The specific process:
(a) First of all, go to the Industrial and Commercial Bureau for a business license, registered as an enterprise, can be a legal person enterprise, unincorporated business, sole proprietorship, partnership, etc., the individual businessman can not apply for the filing of certificates.
(ii) and then to the Quality Supervision Bureau for the organization code certificate.
(c) finally to the State Food and Drug Administration website with the organization code to register an account, online reporting.
(d) online filing of "medical device filing application form" need to submit electronic materials, which add * for the required items.
The operation of Class II medical device conditions:
A, 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;
Two, with the scale and scope of operation of relatively independent premises;
Three, with the scale and scope of operation of the storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
Four, should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
V. Should have the appropriate technical training and after-sales service capacity with its medical device products, or agreed by the third party to provide technical support.
Three categories of medical devices:
The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices. For example, scalpels, surgical scissors, gauze bandages, medical ice packs, stethoscopes and so on.
The second category is a moderate risk, the need for strict control management to ensure its safety, effective medical devices. For example, thermometers, sphygmomanometers, electrocardiographs, nebulizers, etc., which are common in our daily lives.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. For example, common contact lenses, syringes, intravenous indwelling needles, cardiac stents, respiratory machines, ct, nuclear magnetic **** vibration.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 40 Engaged in the operation of medical devices, there should be with the scale of operation and the scope of operation of the business premises and storage conditions, as well as with the operation of the medical device appropriate quality management system and quality management institutions or personnel.
Article 41 engaged in the second class of medical devices, by the business enterprise to the municipal people's government in charge of drug supervision and management of the location of the municipal people's government for the record and submit to meet the conditions of Article 40 of these Regulations, the relevant information. In accordance with the provisions of the drug supervision and management department of the State Council, the safety and effectiveness of the product is not affected by the circulation process of the second class of medical devices, can be exempted from the business record.
"Measures for the Administration of Medical Device Business License"
Article 6 The application for "Medical Device Business License" shall also have the following conditions:
(a) with the scale of operation and business scope of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.