Problems in Existing Domestic Regulations and Regulatory Practices

Imported medical devices produced abroad, if they are to be circulated and used within the territory of China, need to be filed or registered with the drug supervision and administration department through the imported medical device agent. As a bridge between overseas production enterprises and domestic regulatory authorities, the system of agents of imported medical devices plays an important role in regulating the supervision and management of imported medical devices.

The author will study and discuss the management system of imported medical device agents from the three aspects of domestic regulations and problems, foreign management mode and management proposal. As one of the series, this paper will summarize the relevant provisions of the agents of existing overseas medical device manufacturers in China, and on this basis, put forward the problems and confusions in the current regulatory practice.

The Regulations on the Supervision and Administration of Medical Devices provide that the overseas production enterprise of medical devices shall, by its representative office established in China or designate the legal person of the enterprise within china as an agent, submit to the regulatory authorities for the filing/application for registration information and the supporting documents of the competent department of the country (region) where the applicant is located for approval of the medical device for sale (Article 10 of the Regulations on Medical Device Supervision and Administration) Article 2, Article 11 ( 2) ), provides that the name, address and contact information of the agent shall be included in the specification (Article 42(2) of the Regulations on the Supervision and Administration of Medical Devices, and the handling of advertising permits to the place of the agent (Article 45(2) of the Regulations on The Supervision and Administration of Medical Devices).

At the regulatory level, the Measures for the Administration of The Registration of Medical Devices and the Measures for the Administration of the Registration of In vitro Diagnostic Reagents specify the specific obligations of the agents in the filing and registration, and also specify that the drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the principle of territorial management, carry out daily supervision and management of the registration and filing of imported medical device agents (Article 63 of the Measures for the Administration of Registration of Medical Devices). The Measures for the Administration of Recall of Medical Devices provide that the agents designated by the foreign manufacturers of imported medical devices in China shall be regarded as production enterprises and shall fulfill their recall obligations, and shall specify the obligation of the two parties to inform each other (Articles 3 and 6 of the Measures for the Administration of Medical Device Recalls). The Measures for the Monitoring and Reevaluation of Adverse Events of Medical Devices stipulate that the agents designated by the overseas holders shall undertake the monitoring of adverse events of imported medical devices sold in China and cooperate with the overseas holders in fulfilling the obligation of re-evaluation. It also stipulates the need for both sides to establish a mechanism for the transmission of information and to exchange timely information on the monitoring and re-evaluation of adverse events of medical devices (Article 3, 3, 15, 27 and 53 of the Measures for the Monitoring and Reevaluation of Adverse Events of Medical Devices).