Legal analysis: 1, the medical device business record certificate and medical device license validity of the difference: from the validity of the medical device business record certificate temporarily does not specify the validity of the medical device license is valid for five years.
2, medical equipment business record certificate and medical equipment business license on the content of the differences:
From the certificate on the content of the certificate, medical equipment business license contains license number, enterprise name, legal representative, responsible person, residence, business premises, business mode, business scope, warehouse address, issuing department, date of issuance and validity, and so on. Matters; medical device business filing certificate sets out the number, enterprise name, legal representative, person in charge of the enterprise, residence, place of business, mode of operation, business scope, warehouse address, filing department, filing date and other matters.
Legal basis: "supervision and management of medical devices regulations"
Article XIII of the first class of medical devices to implement product filing management, the second and third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle of the development, production, operation and use of medical devices in the whole process of safety, effectiveness and bear responsibility according to law.
Article XIV of the first class of medical device products for the record and apply for the second and third class of medical device product registration, the following information shall be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product instructions and labeling samples;
(F) and product development, production and quality management system documents;
(G) to prove that the product is safe, effective and other information required.
The product inspection report shall meet the requirements of the State Council drug supervision and management department, can be the applicant for registration of medical devices, the filer of the self-inspection report, or commissioned by a qualified medical device inspection agency issued the inspection report.
Conforms to the provisions of Article 24 of the Regulations exempt from clinical evaluation of the situation, may be exempt from submitting clinical evaluation information.
Applicants for registration of medical devices, the filer shall ensure that the information submitted is legal, true, accurate, complete and traceable.
Article XV of the first class of medical device products for the record, by the filer to the municipal people's government in charge of drug supervision and management of the location of the filing information submitted to the department.
Overseas filers exporting Class I medical devices to the territory of China, the designated enterprise legal person in China to the State Council Drug Administration to submit the filing information and the filer's country (region) competent authorities to authorize the sale of the medical device on the market documents. Innovative medical devices not listed outside the country can not be submitted to the filer's country (region) competent authorities to authorize the marketing of the medical device documents.
The filer submits to the department in charge of drug supervision and management of the filing information in accordance with the provisions of these regulations will be completed after the filing. Supervision and management of drugs should be responsible for drug supervision and management of the department shall be received from the date of filing information within five working days, through the State Council drug supervision and management of online government services platform to the community to announce the filing of relevant information.
Filing information contained in the matter of change, should be filed to the original record department to change the record.