Regarding the Required Information and Some Precautions for Import Medical Device Declarations

  Author:MeCan Medical–ultrasound machine manufacturers

Medical equipment refers to direct or indirectly used in the body's instruments, equipment, appliances, in vitro diagnostic reagents and calibrations, materials, and other similar or related items, including the required computer software. I believe that many people have certain questions and questions about imported medical devices. Now I will introduce the information and some precautions for the application required by imported medical device declarations.

Information required for import medical device declaration:

1. Contract, invoice, bill of lading;

2. Automatic import license (some device required for the O certificate);

3. Compulsory certification (part of the device needs);

4. Importer enterprise business license;

5. First category of medical device product filing vouchers or registered certificates of the second and third categories of medical device products;

6. Importer's second category of medical device business filing vouchers;

7. Importer's third category of medical device business licenses;

8. Pressure container manufacturing license (some equipment needs);

9. The import license of the dual -purpose item (some pharmaceutical equipment or diagnostic reagents are required);

10. Approval form for special items (required for some medical diagnostic reagents).

The consignee of imported goods on the statutory inspection of imported goods declares to the customs customs; within 20 days after the customs clearance is released, it will apply for inspection to the destination customs.

Several precautions of imported medical devices:

1. It is forbidden to import old medical devices "new with the old charging"

According to the "Regulations on the Supervision and Administration of Medical Device": prohibit the imported medical devices that have been used in expired, failure, elimination, etc.

2. Transportation and storage should meet the special requirements of dental medical equipment

Transportation and storage of medical devices shall meet the requirements of medical device manuals and labels. If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures should be taken to ensure the safety and effectiveness of medical equipment. If the goods are treated, some packaging is squeezed and damaged, and the content of the content is affected. The customs shall be refunded or destroyed on the cargo according to law to effectively protect the health and safety of Chinese consumers.

3. Customs inspection without the destination cannot be sold and used without authorization

Stomatological equipment that passed the customs inspection without destinations cannot be sold without authorization, otherwise it will confiscate illegal income in accordance with the "Regulations on the Implementation of the Inspection Law of the People's Republic of China" and be fined by 5%or less. If a crime is criminal, criminal responsibility is investigated in accordance with the law.

Regarding the Required Information and Some Precautions for Import Medical Device Declarations 1

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