Customs Knowledge: Import of Medical Devices

作者：迦泰通报关 电话：18521306667 来源:www.jtia56.cn 发布日期：2023-10-10 21:18:19

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Medical devices, as a special commodity related to the health and even life safety of the people, have always been regarded as high-risk commodities for supervision by various countries. Do you know anything about importing medical devices?

About medical devices

1、 What is a medical device

Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software; Its effectiveness is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only play an auxiliary role. Its purpose is to:

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

（2） Diagnosis, monitoring, treatment, relief or functional compensation of injuries;

（3） Testing, substitution, regulation, or support of physiological structures or processes;

（4） Support or maintenance of life;

（5） Pregnancy control;

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

2、 Classification of medical devices

The state implements classified management of medical devices based on their degree of risk.

The first type is medical devices with a low level of risk, and implementing routine management can ensure their safety and effectiveness.

The second type is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness.

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

The current "Classification Catalogue of Medical Devices" was issued by the former State Food and Drug Administration Announcement No. 104 of 2017, and adjusted and updated by the State Food and Drug Administration Announcement No. 147 of 2020.

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

Supervision and Inspection of Imported Medical Devices

1、 Legal basis

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

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

Regulations on the Supervision and Administration of Medical Devices

Announcement No. 17 of 2006 on Strengthening Supervision and Management of Imported Donated Medical Devices (formerly issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, the Ministry of Commerce, the Ministry of Civil Affairs, and the General Administration of Customs)

Announcement on the Implementation of Online Verification of 7 Regulatory Documents, including the "Import Drug Customs Clearance Form" (Announcement No. 148 of 2018 of the General Administration of Customs and the National Drug Administration)

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

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

2、 Regulatory requirements

Product Qualification Requirements

The imported medical devices shall be registered or registered in accordance with Chapter 2 of the Regulations on the Supervision and Administration of Medical Devices.

Medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical needs may import them with the approval of the drug regulatory department of the State Council or the people's governments of provinces, autonomous regions, and municipalities authorized by the State Council. Imported medical devices should be used for specific medical purposes within designated medical institutions.

Prohibit the import of expired, expired, and obsolete medical devices that have already been used.

Product safety requirements

Imported medical devices belonging to mechanical and electrical products must comply with the mandatory requirements of the GB9706 "Classification of Medical Electrical Equipment" series standards and GB2894-2008 "Safety Signs and Guidelines for Use" for their electrical and mechanical safety items and safety warning labels.

Product manual and label requirements

Imported medical devices should have Chinese instructions and labels. The instruction manual should specify the origin of the medical device and the name, address, and contact information of the domestic enterprise legal person designated by the overseas medical device registrant and registrant in China.

The instructions and labels of medical devices should indicate the following:

(1) Common name, model, and specification;

(2) The names, addresses, and contact information of the medical device registrant, registrant, and entrusted production enterprise;

(3) Production date, service life or expiration date;

(4) Product performance, main structure, and scope of application;

(5) Taboos, precautions, and other contents that require warning or reminder;

(6) Installation and usage instructions or illustrations;

(7) Maintenance and upkeep methods, special transportation and storage conditions and methods;

(8) Other contents that should be indicated in the product technical requirements.

The second and third categories of medical devices should also indicate the medical device registration certificate number.

Medical devices used by consumers themselves should also have special instructions for safe use.

3、 Inspection location

In principle, imported medical devices are inspected at the declared destination.

For imported medical devices that need to be inspected in conjunction with installation and debugging, the place of use should be clearly defined during the declaration, and the inspection should be carried out at the place of use.

Imported cardiac pacemakers are inspected at designated ports such as Beijing, Shanghai, and Hainan, and tested at designated nationally recognized medical device testing institutions.

FAQ:

How to determine if the product is an approved registered medical device?

The medical device approved for registration refers to the medical device that is consistent with the limited content of the medical device registration certificate and attachments and is produced within the validity period of the medical device registration certificate. To distinguish the authenticity of the medical device registration certificate, you can log in to the website of the National Drug Administration https://www.nmpa.gov.cn/ Conduct a query.

2. Is it necessary to provide a medical device registration certificate for imported medical devices used for scientific research testing?

Products used for scientific research testing but not for human diagnosis or treatment may not go through relevant registration and filing procedures, but enterprises must truthfully declare. Customs strictly verify the true use of imported medical devices declared for scientific research testing but not for human diagnosis or treatment, and if it is found that they are used for human diagnosis or treatment in violation of regulations, according to relevant laws and regulations, order enterprises to return or destroy them.

3. Do imported medical device components require medical device filing or registration?

The components of imported medical devices provided to medical device manufacturers as production materials do not require separate medical device filing or registration.

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