Latest declaration process for imported medical device online verification

Recently, China Customs and the National Medical Products Administration have optimized and upgradedMedical Equipmentthe 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 should be those registered or filed under 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 III medical devices. For Class I medical devices, the license category should be 629-First Class Medical Device Filing Certificate; for Class II or III medical devices, the license category should be 612-Medical Device Registration Certificate.

Goods attributes are divided into three categories: medical devices, medical device components, and non-medical devices. Medical devices include products that meet the definition and scope described in the Medical Device Classification Catalog. Medical device components include parts or combination components listed in the First Class Medical Device Product Catalog or Medical Device Classification Catalog as production materials for medical device manufacturers or specified in the structure and composition section of the medical device registration certificate. Non-medical devices include products with principles, structures, or functions similar to medical devices but not covered by the definition of medical devices in the Regulations on the Supervision and Administration of Medical Devices.

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

Industrial X-ray tubes: The goods attribute should be declared as 38-Non-medical device, and no 612-Medical Device Registration Certificate is required.

Medical X-ray tubes for originally registered products: If the purpose is to replace consumables, provide after-sales service, or repair, and the medical X-ray tube is listed in the structure and composition section of the original products medical device registration certificate, the goods attribute should be declared as 37-Medical device components, and the original products 612-Medical Device Registration Certificate must be entered.

Medical X-ray tubes for medical device registration testing: If the medical X-ray tube needs to be sent to a third-party agency for testing or clinical trials, the goods attribute should be declared as 35-Class II medical device, and the 612-Medical Device Registration Certificate must be entered, with the license number declared as 612 test sample.

Medical X-ray tubes temporarily exported and re-imported: The goods attribute should be declared as 35-Class II medical device, and the 612-Medical Device Registration Certificate must be entered, with the license number declared as 612 temporarily exported and re-imported.

If the goods attribute is declared as 34-Class I medical device, no other categories may be declared simultaneously; additionally, the 629-First Class Medical Device Filing Certificate must be entered.

If the goods attribute is declared as 35-Class II medical device, no other categories may be declared simultaneously; additionally, the 612-Medical Device Registration Certificate must be entered.

If the goods attribute is declared as 36-Class III medical device, no other categories may be declared simultaneously; additionally, the 612-Medical Device Registration Certificate must be entered.

For goods categorized as 37-Medical Device Components, no other categories may be simultaneously declared; additionally, 612-Medical Device Registration Certificate or 629-Class I Medical Device Filing Certificate may be entered as applicable.

For goods categorized as 38-Non-Medical Devices, no other categories may be simultaneously declared; furthermore, neither 612-Medical Device Registration Certificate nor 629-Class I Medical Device Filing Certificate may be entered.

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 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. For imported medical device products that have not obtained a Medical Device Registration Certificate but fall under relevant scenarios, enter 612XXXXXX in the License Number field; for those without a Class I Medical Device Filing Certificate but qualifying under relevant scenarios, enter 629XXXXXX in the License Number field.

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