What are the regulations for countries or hospitals that import products without medical device production license?

Article 10 of the Regulations on the Supervision and Administration of Medical Devices The filing of Class I medical device products shall be submitted by the filing person to the food and drug supervision and administration department of the municipal people's government where the district is located. Among them, the product inspection report can be the self-inspection report of the filing person; Clinical evaluation data does not include clinical trial reports, but it can be data obtained through literature and clinical use of similar products to prove the safety and effectiveness of medical devices.

Overseas production enterprises that export Class I medical devices to China shall, through their representative offices established in China or designated enterprise legal persons as agents, submit filing materials and certification documents of relevant competent authorities in the country (region) where the filer is located to the food and drug supervision and administration department of the State Council.

Extended information Article 15 The medical device registration certificate is valid for 5 years. If it is necessary to renew the registration at the expiration of the validity period, an application for renewal of registration shall be filed with the original registration department six months before the expiration of the validity period.

Except in the circumstances specified in the third paragraph of this article, the food and drug supervision and administration department that receives the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed as approval.

In any of the following circumstances, the registration shall not be renewed:

(a) the registrant fails to apply for renewal of registration within the prescribed time limit;

(2) The mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration cannot meet the new requirements;

(3) failing to complete the items specified in the medical device registration certificate within the prescribed time limit for medical devices urgently needed for treating rare diseases and responding to public health emergencies.

Baidu Encyclopedia-Regulations on the Supervision and Administration of Medical Devices (20 17 Edition)