(I) Product qualification requirements
Imported medical devices shall be those that have been registered or filed in accordance with the provisions of Chapter II of the Regulations on the Supervision and Administration of Medical Devices.
Imported medical devices shall have Chinese instructions and Chinese labels. The instructions and labels shall comply with the provisions of these Regulations and the requirements of relevant mandatory standards, and shall state the place of origin of the medical device and the name, address and contact information of the domestic legal person designated by the overseas medical device registrant or registrant in my country. No Chinese instructions or labels or instructions or labels that do not comply with the provisions of this article shall be imported.
If a medical institution urgently needs to import a small amount of Class II or Class III medical devices, it may import them with the approval of the drug supervision and administration department of the State Council or the people’s government of the province, autonomous region or municipality directly under the Central Government authorized by the State Council. Imported medical devices shall be used for specific medical purposes in designated medical institutions.
It is prohibited to import expired, invalid, obsolete and other used medical devices.
(II) Product safety requirements
For imported medical devices that are electromechanical products, their electrical and mechanical safety items and safety warning signs must comply with the mandatory requirements of GB9706 “Classification of Medical Electrical Equipment” series of standards, GB2894-2008 “Safety Signs and Guidelines for Their Use” and other standards.
(III) Product instructions and labeling requirements
The instructions of imported medical devices should state the origin of the medical device and the name, address and contact information of the domestic corporate legal person designated by the overseas medical device registrant and recorder.
The instructions and labels of medical devices shall indicate the following items:
(1) Generic name, model, and specifications;
(2) Name, address, and contact information of the medical device registrant, recorder, and entrusted manufacturer;
(3) Production date, service life, or expiration date;
(4) Product performance, main structure, and scope of application;
(5) Contraindications, precautions, and other contents that require warnings or prompts;
(6) Installation and use instructions or diagrams;
(7) Maintenance and care methods, special transportation and storage conditions and methods;
(8) Other contents that should be indicated as required by the product technical requirements.
Class II and Class III medical devices shall also indicate the medical device registration certificate number.
Medical devices used by consumers themselves shall also have special instructions for safe use.
Qualification requirements for import consignees
(1) Medical device business license (the goods belong to the second and third category medical devices in the “Medical Device Classification Catalogue”).
The validity period of the medical device business license is 5 years.
(2) Business license (the business scope includes a license to sell medical devices).