Medical device filing refers to the food and drug supervision and management department of the medical device filer to submit the first class of medical device filing information on file for inspection.
Difference between medical device filing and license:
1, the filing and license of the adaptive device categories are different.
Operation of Class I and Class II medical devices need to be medical device filing certificate, the operation of Class III medical devices need to operate the production license.
2, the record and license of the management body is not necessarily the same.
The first class of medical devices within the territory of the municipal food and drug supervision and management department to be filed.
The third class of medical devices within the territory of the State Food and Drug Administration to review and approve the issuance of medical device registration certificate.
Imported Class I medical devices by the State Food and Drug Administration for the record.
Imported Class II and Class III medical devices by the State Food and Drug Administration for review, approval and issue of medical device registration certificate.
3, the two based on different laws and regulations.
Filing: "Medical Device Registration and Filing Administrative Measures"
License: "Regulations for the Supervision and Administration of Medical Devices" and "Medical Device Business License Management Measures".
Licensing system, refers to the relevant units approved, permitted to operate, the operation is legal, subject to administrative approval, has a strong legal binding effect. Usually only after the business license will have an industrial and commercial business license.
Filing system, refers to the relevant units to apply for the record, the general registration is the name of the business project, scale, industry, responsible person and other information. The filing increases the responsibility of the legally responsible person to regulate.
Generally, the record as long as you go to the relevant unit to apply, basically will get the record, but the license to handle, the need to review the business project, the requirements are also very strict, there is a very strong legal provisions.