No need to file online first. Directly by the business enterprise to the location of the municipal people's government food and drug supervision and management department for the record and submit their terms and conditions in line with the relevant information.
The second class of medical devices business administrative license conditions specific matters
1, the legal representative of the enterprise, the person in charge of the enterprise, quality management personnel should not be "supervision and management of medical equipment regulations" Article 40 of the situation.
2, the enterprise should have with the scale and scope of operation of the quality management organization or full-time quality management personnel.
3, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
4, should be in accordance with relevant national and local regulations, the establishment of a sound and necessary quality management system, and strictly enforced.
5, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
6, in accordance with the "Guangdong Province to start the medical device business acceptance of the implementation of standards" acceptance.
Expanded Information:
Legal provisions for the operation of Class II medical devices:
According to the "Supervision and Administration of Medical Devices Regulations", Chapter IV, Article 30 provides that: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the district in the area of the location of the Food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of these regulations to prove the information.
Article 29 to engage in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
The applicant by deception, bribery and other improper means to obtain "medical device business enterprise license", (food) drug supervision and management department shall revoke its "medical device business enterprise license", give a warning, and impose a fine of 10,000 yuan or more than 20,000 yuan.
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