Imported medical device inspection and supervision

　　1. Medical equipment

　　Medical device definition

　　According to Article 76 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council), medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or Related items, including the required computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:

　　(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

　　(2) Injury diagnosis, monitoring, treatment, alleviation or functional compensation;

　　(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;

　　(four) life support or maintenance;

　　(5) Pregnancy control;

　　(6) Provide information for medical or diagnostic purposes by examining samples from the human body.

　　Medical device classification

　　According to Article 4 of the Regulations on the Supervision and Administration of Medical Devices, the state implements classified management of medical devices according to the degree of risk.

　　The first category is medical devices that have a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness.

　　The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.

　　The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.

　　Medical device product registration and filing

　　According to Article 8 of the Regulations on the Supervision and Administration of Medical Devices, the first category of medical devices is subject to product registration management, and the second and third categories of medical devices are subject to product registration management.

　　Medical Device Classification List

　　On August 31, 2017, the former State Food and Drug Administration issued the "Announcement on Issuing a Classification Catalog of Medical Devices" (2017 No. 104), which will be implemented on August 1, 2018. The "Medical Device Classification Catalogue" attached to the announcement includes 22 sub-categories such as active surgical instruments and passive surgical instruments, with more than 60,000 examples of product names.

Customs officers of Yuexiu Customs under Guangzhou Customs are supervising imported medical angiography X-ray systems

　　2. Inspection and supervision of imported medical devices

　　Legal basis

　　"The Import and Export Commodity Inspection Law of the People's Republic of China"

　　Article 5 The import and export commodities listed in the catalog shall be inspected by the commodity inspection agency.

　　The imported commodities specified in the preceding paragraph are not allowed to be sold or used without inspection; the export commodities specified in the preceding paragraph are not allowed to be exported if they fail to pass the inspection.

　　Article 11 The consignees or their agents of imported commodities that must be inspected by the commodity inspection agency as stipulated in this law shall report to the commodity inspection agency of the customs declaration place for inspection.

　　Article 12 The consignees or their agents of imported commodities that must be inspected by the commodity inspection agency as stipulated in this law shall accept the inspection of the imported commodities by the commodity inspection agency at the place and within the time limit specified by the commodity inspection agency. The commodity inspection agency shall complete the inspection within the time limit uniformly stipulated by the national commodity inspection department and issue an inspection verification form.

　　Article 33 In violation of the provisions of this law, import commodities that must be inspected by the commodity inspection agency are sold or used without approval, or export commodities that must be inspected by the commodity inspection agency are exported without approval of the inspection. The commodity inspection agency shall confiscate the illegal income and impose a fine of not less than 5 percent but not more than 20 percent of the value of the goods; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

　　Article 35 If the import or export is adulterated, fake, fake, shoddy, or substandard import and export commodities pretending to be qualified import and export commodities, the commodity inspection authority shall order the import or export to be stopped, and the illegal income shall be confiscated , And impose a fine of more than 50% and less than three times the value of the goods; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

　　"Implementation Regulations of the Import and Export Commodity Inspection Law of the People's Republic of China"

　　Article 16 The consignee of imported goods subject to statutory inspection shall present the contract, invoice, packing list, bill of lading and other necessary vouchers and relevant approval documents to the entry-exit inspection and quarantine agency at the customs declaration place; within 20 days after customs clearance , The consignee shall apply to the entry-exit inspection and quarantine agency for inspection in accordance with the provisions of Article 18 of these regulations. Imported commodities subject to statutory inspection that have not been inspected shall not be allowed to be sold or used.

　　For imported commodities subject to verification management, the consignee shall apply to the entry-exit inspection and quarantine agency at the customs declaration place for verification. The entry-exit inspection and quarantine agency shall conduct verification in accordance with the regulations of the General Administration of Customs.

　　Article 17 For imported commodities subject to legal inspection and verification management, the customs shall handle customs clearance procedures in accordance with regulations.

　　Article 18 Imported commodities subject to statutory inspection shall be inspected at the destination declared by the consignee at the time of inspection.

　　Article 19 Except as otherwise provided by laws and administrative regulations, if the statutory inspection of imported goods has been inspected and the items related to personal and property safety, health, and environmental protection are not qualified, the entry-exit inspection and quarantine agency shall order the party concerned to destroy it, or issue a return for disposal. Notice, go through the return procedures; if other items are unqualified, technical processing can be carried out under the supervision of the entry-exit inspection and quarantine agency, and only those that pass the re-inspection can be sold or used. Where the party concerned applies for the issuance of the certificate by the entry-exit inspection and quarantine agency, the entry-exit inspection and quarantine agency shall issue the certificate in a timely manner.

　　Article 20 Imported commodities other than statutory inspections that fail to pass the random inspection by the entry-exit inspection and quarantine agency shall be dealt with in accordance with the provisions of Article 19 of these regulations.

　　Imported commodities subject to verification management that fail to pass the verification by the entry-exit inspection and quarantine agency shall be handled in accordance with the provisions of Article 19 of these Regulations or transferred to relevant departments for processing.

　　Article 43: Anyone who sells or uses imported commodities that have not been submitted for inspection or has not been inspected that are subject to statutory inspections, or sells or uses imported commodities that should be subject to import verification but have not been applied for, shall be confiscated by the entry-exit inspection and quarantine agency. , And impose a fine of 5% to 20% of the value of the goods; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

　　Article 45 Anyone who sells or uses imported commodities that have passed statutory inspection, random inspection or verification, or exports commodities that have passed statutory inspection, random inspection or verification, shall be ordered by the entry-exit inspection and quarantine agency to stop the sale, use or For export, confiscate illegal income and illegally sold, used or exported commodities, and impose a fine of not less than three times the value of the illegally sold, used or exported commodities; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

　　"Regulations on the Supervision and Administration of Medical Devices" (Order No. 680 of the State Council)

　　Article 42 Imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter 2 of these Regulations.

　　Article 43 The entry-exit inspection and quarantine agency shall conduct inspections on imported medical devices according to law; those that fail the inspection shall not be imported.

　　"Announcement on Strengthening the Supervision and Administration of Imported Donated Medical Devices" (formerly AQSIQ, Ministry of Commerce, Ministry of Civil Affairs, General Administration of Customs Announcement No. 17 of 2006)

　　The General Administration of Customs shall implement record registration management on imported donated medical devices before inspection. All overseas donation institutions that donate medical devices to China must apply for registration with the General Administration of Customs by them or their agents in China; medical devices donated by foreign donors must be filed with the General Administration of Customs before inspection, and The General Administration of Customs will conduct a preliminary review of whether the filing materials meet the requirements of Article 1 of this Announcement. When necessary, the General Administration of Customs will organize and implement pre-shipment inspections. For special needs of the country, special handling shall be made by the General Administration of Commerce and Customs of the Ministry of Civil Affairs.

　　Announcement on the Implementation of Online Verification of 7 Types of Regulatory Documents including the Customs Clearance Form for Imported Drugs (General Administration of Customs and National Medical Products Administration Announcement No. 148 of 2018)

　　In order to further optimize the business environment at ports and promote cross-border trade facilitation, the General Administration of Customs and the National Medical Products Administration has implemented electronic data and documentation on imported medical device registration/registration certificates (including medical device registration certificates and first-class medical device registration certificates). Online verification of electronic data of import and export cargo declarations.

　　"Catalogue of Old Mechanical and Electrical Products Prohibited from Import" (Announcement No. 106, 2018 of the Ministry of Commerce and the General Administration of Customs)

　　Old medical, surgical, surgical, dental or veterinary instruments or appliances, X-ray tomography equipment, medical linear accelerators and other old medical devices under the customs commodity number 9018 are included in the "Catalogue of Old Mechanical and Electrical Products Prohibited from Import" and are prohibited import.

　　Announcement on Adjusting Inspection Institutions for Imported Pacemakers (Announcement No. 23, 2020 of the General Administration of Customs)

　　The clinically urgently needed imported cardiac pacemakers approved by the Hainan Provincial Drug Administration shall be subject to the statutory inspection by Haikou Customs.

　　Other imported cardiac pacemakers are inspected by Beijing Customs and Shanghai Customs in accordance with relevant regulations.

　　Three, question answering

　　Q:

　　How to determine whether it is a medical device approved for registration?

　　According to the relevant regulations of the State Drug Administration, medical devices approved for registration refer to medical devices that are consistent with the medical device registration certificate and accessories and are manufactured within the validity period of the medical device registration certificate. If the relevant medical device is consistent with the content of the corresponding medical device registration certificate and accessories and is produced within the validity period of the medical device registration certificate, it is not an unregistered medical device; if it is inconsistent, it is not an approved registered medical device.

　　Q:

　　Our company intends to import medical devices for scientific research and testing. Is it necessary to provide a medical device registration certificate?

　　According to the relevant regulations of the State Drug Administration, products that are used for scientific research and testing but not for human diagnosis and treatment need not go through the relevant registration and filing procedures, and the drug administration department does not need to issue relevant certificates for imports. Your company must declare truthfully. The customs strictly verifies the true use of imported medical devices declared for scientific research and testing but not for human diagnosis and treatment. If they are found to be used for human diagnosis or treatment in violation of regulations, they shall be ordered in accordance with relevant laws and regulations. The enterprise returns or destroys.

　　Q:

　　The product parts and components in the "Product Structure and Composition Attachment Sheet" of our company's imported medical device registration certificate do not indicate specific specifications and model information. Does the relevant imported medical device parts fall within the scope of the registration certificate?

　　According to the relevant regulations of the State Drug Administration, if the medical device registration certificate and its accessories do not indicate the specific specifications and model information of the parts, the medical device registration certificate and its accessories do not limit the specific specifications and models of the parts. Parts that comply with the information on the medical device registration certificate and its attachments may fall within the scope of the medical device registration certificate.

　　Q:

　　Our company intends to import pacemakers, can the statutory inspection be carried out at Guangzhou Customs?

　　According to the "Announcement on Adjusting the Inspection Institutions for Imported Pacemakers" (Announcement No. 23, 2020 of the General Administration of Customs), Beijing Customs, Shanghai Customs, and Haikou Customs are currently conducting inspections in accordance with relevant regulations.