Announcement No.104 of 2017 of the General Administration on Issuing the Classification Catalogue of Medical Devices
.Since August 1, 2018, in accordance with the relevant requirements of the state Administration of Medical Devices No.143 of 2017 , the opinions  on classification  and definition of Class I medical device products  in the Notice on Issuing the Catalogue of  Class l Medical Device Products, the Notice of the General Office of the State Administration of Food and Drug Administration on Matters Related to the Implementation of Class l Medical Device Filing and the classification and definition documents issued after May 30, 2014 remain valid

.The Category of medical devices can be judged accordingly.

Measures for the Supervision and Administration of Medical Device Operation

Engaged in the second type of medical equipment business, business enterprises should be to the local districts of the municipal food and drug supervision and management departments for the record.
The filing management shall be implemented for the operation of Class II medical devices, and the licensing management shall be implemented for the operation of Class 111 medical devices.

Announcement No.53 of 2020 of the General Administration of Customs

In order to strengthen the supervision of the export quality of medical materials, in accordance with the ”Law of the People’s Republic of China on the Inspection of Import and Export Commodities” and its implementing regulations the General Administration of Customs has decided to carrry out the inspection of export commodities for medical materials under”630790010 ”and other customs commodity numbers (see annex for details) from the date of this announcement.

Announcement of the General Administration of Customs of the Ministry of Commerce and the State Drug Administration No.5 of 2020 on Orderly Export of Medical Materials

Since April 1，the customs will verify the registration certification of medical device products and the undertaking letter of the exporter when exporting the 5 kinds of epidemic prevention materials in the annex. If the registration certificate is not listed in the attachment list it is recommended to confirm its validity with the customs of the declaration place before declaration.

The People’s Republic of China Import and Export Commodity Inspection Law”, the People’s Republic of China Import and Export Commodity Inspection Law Implementation Regulations

Export commodities shall be inspected at the place where the cοmmodities are produced. The General Administration of Customs may designate other places for inspection according to the needs of facilitating foreign trade and inspection of import and export commodities.