Machinery / Industrial Parts & Tools

The new revision of the "Regulations on the Supervision and Administration of Medical Devices" for medical devices will be implemented on June 1, 2021.

The adjustment of regulations and policies will certainly arouse the attention of enterprises. In this regard, the editor has sorted out the contents related to customs supervision in the revised "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 739, hereinafter referred to as the "Regulations"), and made preliminary interpretations for enterprises' reference.

1. The customs is still given the function of supervising imported medical devices before they are sold and used.

Article 57 of the Regulations

It stipulates that "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 58 of the Regulations

It stipulates that "the entry-exit inspection and quarantine agency shall conduct inspections of imported medical devices in accordance with the law; if the inspection fails, they shall not be imported." "The State Council's drug regulatory authority shall promptly notify the national entry-exit inspection and quarantine agency of the registration and filing of imported medical devices"

The customs, as an entry-exit inspection and quarantine agency, is still given the function of performing entry verification and inspection of imported medical devices in accordance with the law.

2. The requirements for instructions and labels are more specific

Article 39 of the Regulations

Added "Medical device instructions and labels should indicate ‘special transportation and storage conditions and methods’". When importing medical devices, attention should be paid to whether the state of the goods is consistent with the transportation and storage requirements.

Article 57 of the Regulations

The requirement that "the place of origin of the medical device and the name, address, and contact information of the domestic enterprise legal person in my country designated by the overseas medical device registrant and filing party should be stated in the manual" has been added. In addition, this article retains the previous stipulation that "no Chinese instructions, Chinese labels, or instructions or labels that do not comply with the provisions of this article shall not be imported."

3. The use and disposal of emergency use and unqualified imported medical devices are more detailed and specific

Article 57 of the Regulations

Added "Medical institutions that urgently need to import a small amount of Class II and Class III medical devices due to clinical need may be imported with the approval of the State Council’s drug regulatory department or the people’s governments of provinces, autonomous regions, and municipalities authorized by the State Council. Imported medical devices shall be designated "Used for specific medical purposes in medical institutions" detailed requirements.

According to this article, the customs can supervise such medical devices based on the relevant approval documents. This is also formulated to ensure the safe and effective supply of imported medical devices in the case of emergency use based on the experience gained in my country’s fight against the new crown pneumonia epidemic and other public emergencies. New requirements.

Article 57 and 91 of the Regulations

The provisions of "It is forbidden to import expired, expired, or eliminated medical devices that have been used," and "Imported medical devices in violation of relevant laws and administrative regulations on the inspection of import and export commodities shall be handled by the entry-exit inspection and quarantine agency in accordance with the law." The customs has the right to deal with unqualified imported medical devices, banned medical devices, imported medical devices with unlicensed special equipment components found during supervision.

Medical device importers should pay special attention when purchasing and importing medical devices to avoid unnecessary losses due to violations of the new "Regulations."

Customs fans:

In addition to understanding the "Regulations on the Supervision and Administration of Medical Devices" for customs supervision of imported medical devices, what other laws and regulations should be paid attention to?

12360 Customs Hotline:

This issue is very critical. I will briefly review the laws and regulations related to customs inspection and supervision of imported medical devices that companies should pay attention to. The main ones are the following for reference:

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

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

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

"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)

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

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

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