No need. According to Article 3 of the new Measures for the Supervision and Administration of Medical Device Operation, the operation of Class I medical devices does not require permission and filing; The management of Class II medical devices shall be put on record; The operation of the third category of medical devices is subject to license management. "
Therefore; There is no need to file only the first class medical devices. The production of Class I medical devices requires filing.
Need to record the import of a class of medical devices, what should I do?
Class I medical devices shall be put on record.
Class II and Class III medical devices shall be subject to registration management.
For the filing of Class I medical devices in China, the filing person shall submit the filing materials to the municipal food and drug supervision and administration department with districts.
Category II medical devices in China are examined by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and after approval, medical device registration certificates are issued.
Class III medical devices in China are reviewed by China Food and Drug Administration, and medical device registration certificates are issued after approval.
For the record-keeping of imported medical devices of Class I, the record-keeping person shall submit the record-keeping materials to China Food and Drug Administration.
Imported Class II and Class III medical devices shall be examined by China Food and Drug Administration, and medical device registration certificates shall be issued after approval. The registration of medical devices in Hongkong, Macau and Taiwan Province shall be handled with reference to imported medical devices.
How to file a class of medical device certificates?
For the filing of Class I medical device products, the filing person shall submit the filing materials to the pharmaceutical supervisory and administrative department of the municipal people's government with districts.
General situation of handling materials:
1. Record Form for Class I Medical Devices (1 original (received) and 1 electronic)
2. Safety risk analysis report (1 electronic parts and 1 copy)
3. Product technical requirements (1 electronic parts and 1 copy)
4. Product inspection report (1 electronic parts and 1 copy)
5. Clinical evaluation data (electronic version 1 copy, copy 1 copy)
6. Product description and minimum sales unit label design sample (1 electronic parts and 1 copy)
7. Manufacturing information (1 electronic parts and 1 copy)
8. Certification documents (copies of business license and organization code certificate) (electronic part 1 copy, electronic part 1 copy)
9. Declaration of conformity (1 original (received) and 1 electronic parts)
10. Original and photocopy of the agent's authorization certificate and agent's ID card (original 1 copy (received), electronic part 1 copy).
Legal basis: Article 13 of the Regulations on the Supervision and Administration of Medical Devices implements product filing management for Class I medical devices and product registration management for Class II and Class III medical devices.
Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.
Does the outer packaging of a class of medical devices need to be filed?
No need. According to the new "Measures for the Supervision and Administration of Medical Device Operation", the operation of Class I medical devices does not require permission and filing; The management of Class II medical devices shall be put on record; The operation of the third category of medical devices is subject to license management, and it is not necessary to file the first category of medical devices only, but to file the first category of medical devices.
Legal basis: Measures for the Supervision and Administration of Medical Device Operation
Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of the operation of medical devices nationwide. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.
Do I need to put on record to operate a class of medical devices now?
Of course, it needs to be filed. A class of medical devices has a filing form.