Recently, China Customs and the National Medical Products Administration have optimized and upgraded?Medical Devices?the declaration requirements and verification rules for the online verification of regulatory certificates for imports. These changes aim to further optimize the port business environment and facilitate cross-border trade.

Medical devices are instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including necessary computer software. Their efficacy is primarily achieved through physical means, not pharmacological, immunological, or metabolic means, or if these means are involved, they only play a supporting role. The medical products authority manages medical devices according to a catalog, which includes 22 sub-catalogs, 206 primary product categories, 1,157 secondary product categories, and 6,609 typical product name examples.

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." Product filing management applies to Class I medical devices, while registration management applies to Class II and Class III medical devices. For Class I medical devices, the license category should be "629 - Class I Medical Device Filing Certificate"; for Class II or Class III medical devices, the license category should be "612 - Medical Device Registration Certificate."

Goods are categorized into three types: medical devices, medical device components, and non-medical devices. Medical devices include products that fall within the scope defined and described in the *Medical Device Classification Catalog*. Medical device components refer to parts or combined components listed in the "Structure and Composition" section of a medical device registration certificate, which are supplied to medical device manufacturers as production materials for manufacturing medical devices, as defined and described in the *Catalog of Class I Medical Devices* or the *Medical Device Classification Catalog*. Non-medical devices include products whose principles, structure, or functions resemble those of medical devices but do not meet the definition of medical devices under the *Regulations on the Supervision and Administration of Medical Devices*.

Using X-ray tubes as an example, here are four common declaration scenarios:

1. Industrial X-ray tubes: The goods attribute should be declared as "38 - Non-medical devices," and there is no need to enter "612 - Medical device registration certificate."

2. For medical X-ray tubes used in originally registered products: If the purpose is for replacing consumables, after-sales service, maintenance, etc., and the medical X-ray tube is listed in the "Structure and Composition" section of the medical device registration certificate for the originally registered product, the goods attribute should be reported as "37-Medical Device Components," and the "612-Medical Device Registration Certificate" of the originally registered product must be entered.

3. Medical X-ray tubes for medical device registration testing: For medical X-ray tubes that need to be sent to a third-party organization for testing or clinical trials, the goods attribute should be reported as "35-Class II Medical Devices." It is necessary to enter "612-Medical Device Registration Certificate," and the "License Number" should be reported as "612 Testing Samples."

4. Medical X-ray tubes temporarily exported and then re-imported: The "Goods Attribute" should be declared as "35-Class II Medical Devices," and the "612-Medical Device Registration Certificate" must be entered. The "License Number" should be filled in as "612 Temporary Export and Re-import."

1. For goods categorized as "34-Class I Medical Devices," no other categories may be simultaneously declared. Additionally, it is mandatory to enter "629-First-Class Medical Device Filing Certificate."

2. For goods categorized as "35-Class II Medical Devices," no other categories may be reported simultaneously. Additionally, the "612-Medical Device Registration Certificate" must be entered.

3. For goods declared as "36-Class III Medical Devices," no other categories may be declared simultaneously. Additionally, it is mandatory to enter "612-Medical Device Registration Certificate."

4. For goods categorized as "37 - Medical Device Components," no other categories may be simultaneously declared. Additionally, depending on the circumstances, either "612 - Medical Device Registration Certificate" or "629 - Class I Medical Device Filing Certificate" may be entered.

5. For goods categorized as "38-Non-Medical Devices," no other categories may be reported simultaneously. Additionally, entries such as "612-Medical Device Registration Certificate" or "629-First-Class Medical Device Filing Certificate" must not be recorded.

Based on actual import trade practices, customs has categorized and classified 14 scenarios where providing a medical device registration certificate/Class I medical device filing certificate is not mandatory.

Based on the actual practices of import trade, customs has categorized and summarized relevant scenarios where the provision of a Medical Device Registration Certificate/Class I Medical Device Filing Certificate is not mandatory, totaling 14 types. For imported medical device products that have not obtained a "Medical Device Registration Certificate" but fall under the relevant scenarios, the "License Number" field should be filled with "612XXXXXX"; for those that have not obtained a "Class I Medical Device Filing Certificate" but fall under the relevant scenarios, the "License Number" field should be filled with "629XXXXXX".

The above content is sourced from the customs release.?Zhong Shen?As a one-stop import?Export Agency?service provider, we can offer customized?Import/export?solutions for various industries. If you require?Foreign trade?import-export agency services, please contact us for business consultation. Hotline: 139-1787-2118.