Regulations on the supervision and management of inbound and outbound express shipments and medical devices

Management requirements for inbound and outbound express shipments

According to the relevant regulations of the national customs, inbound and outbound express shipments are divided into three categories: documents (category A express), personal belongings (category B express) and low-value goods (category C express). Category A express items refer to documents, documents and information with no commercial value. Category B express items refer to items for personal use. The total value must be within 800 RMB (if sent to Hong Kong, Macao and Taiwan), 1,000 RMB (if sent to Hong Kong, Macao and Taiwan). to other countries and regions). Category C express shipments refer to goods not exceeding 5,000 yuan and must comply with relevant customs restrictions.

Specific regulations must be followed when carrying and mailing proprietary Chinese medicines out of the country. In particular, mailed Chinese patent medicines should not contain items on the national export ban list. At the same time, personal mailings of Chinese medicines and proprietary Chinese medicines also need to comply with customs requirements on variety and value. Personal items, such as clothes and cosmetics, that enter the country through express delivery channels such as DHL must be declared as Class B express items and must comply with customs value restrictions.

Classification and management of medical devices

According to the “Regulations on the Supervision and Administration of Medical Devices”, medical devices are defined as various products used directly or indirectly on the human body, including instruments, equipment and in vitro diagnostic reagents. Medical devices are classified into three categories: the first category is low risk and can be managed conventionally; the second category is moderate risk and requires strict control; the third category is high risk and requires special measures to be controlled and managed.

Class I medical devices require filing, while Class II and III medical devices must be registered. The application process includes submitting corresponding application materials to the municipal or provincial drug regulatory department. The medical device registration certificate is valid for 5 years.

Import requirements for medical devices

For imported medical devices, registration or filing documents must be provided, along with Chinese instructions and labels. The instructions must provide detailed product information, including origin, period of use and performance, otherwise import will not be allowed. At the same time, the import of any expired or obsolete medical devices is prohibited.

Even if medical devices are used for scientific research and testing, if they are used for human diagnosis and treatment, they still need to go through relevant registration and filing procedures, and customs will strictly verify their use. Medical devices imported through formal channels must hold an “Inbound Goods Inspection and Quarantine Certificate” issued by the customs to ensure their authenticity and compliance.

Through the above management regulations and standards, the country is committed to ensuring the safety and effectiveness of inbound and outbound express shipments and medical devices, and promoting public health and safety.