Legal analysis: Article 1 is to regulate the behavior of imported medical device agents. According to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council of the People's Republic of China), "Medical Device Registration and Management" "Measures" (State Food and Drug Administration Order No. 4) and "In Vitro Diagnostic Reagents Registration Management Measures" (State Food and Drug Administration Order No. 5), formulate these regulations.
Article 2: Imported medical device agents refer to overseas manufacturing enterprises that export medical devices to the territory of my country. They shall establish representative offices in my country or designate corporate legal persons in my country to register or file medical device products. agent.
Article 3 Imported medical device agents and their supervision and management in Beijing shall abide by these regulations.
Legal basis: "Regulations on the Administration of Agents for Imported Medical Devices"
Article 1 is to regulate the behavior of agents for imported medical devices. According to the "Regulations on the Supervision and Administration of Medical Devices" (People's Republic of China* **The State Council Order No. 650), the "Medical Device Registration Management Measures" (State Food and Drug Administration Order No. 4) and the "In Vitro Diagnostic Reagents Registration Management Measures" (State Food and Drug Administration Order No. 5 ), formulates these regulations.
Article 2: Imported medical device agents refer to overseas manufacturing enterprises that export medical devices to the territory of my country. They shall establish representative offices in my country or designate corporate legal persons in my country to register or file medical device products. agent.
Article 3 Imported medical device agents and their supervision and management in Beijing shall abide by these regulations.
Article 4 Agents for imported medical devices (hereinafter referred to as agents) shall cooperate with overseas applicants or filing persons in relevant work in accordance with the requirements of these regulations, assume agent responsibilities and perform agent obligations in accordance with the law.
Article 5 The Beijing Municipal Food and Drug Administration (hereinafter referred to as the Municipal Bureau) is responsible for organizing and guiding the supervision and management of agents in the city. The district Food and Drug Administration (hereinafter referred to as the district bureau), the Beijing Municipal Food and Drug Administration The branches directly under the Supervision and Administration Bureau (hereinafter referred to as the directly affiliated branches) are responsible for the specific supervision and management of agents within their jurisdiction.