Attachment

"Shanghai Class II Medical Device Emergency Approval Procedures"

Article 1 In order to effectively prevent, timely control and eliminate the harm of public health emergencies and meet the rapid review, approval and listing of medical devices urgently needed in response to public health emergencies in this city, according to the Regulations on the Supervision and Administration of Medical Devices and the Registration of Medical Devices This procedure is formulated in accordance with the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, and the Emergency Approval Procedures for Medical Devices of the State Drug Administration.

Article 2 This procedure is applicable to the emergency needs of public health emergencies in Shanghai, but there are no similar products on the market in this city, or although similar products are already on the market, the supply of related products cannot meet the public health emergencies in this city. The review and approval of the second-class medical device in this city that is required for emergency treatment and confirmed by the Shanghai Municipal Drug Administration.

Article 3 The Shanghai Municipal Drug Administration decides the time for starting and terminating this procedure according to the situation and changes of public health emergencies in this city and in combination with the medical device guarantee required for responding to public health emergencies in this city.

After the start of this procedure, the applicant shall submit the "Application Form for Emergency Approval of Class II Medical Devices" to the Shanghai Municipal Drug Administration, submit an application for emergency approval of Class II medical devices, and attach relevant product overview materials, product development overview, Product technical requirements.

Article 4 For the Class II medical devices confirmed by the Shanghai Municipal Drug Administration for emergency approval (hereinafter referred to as the medical devices confirmed for emergency approval), the Shanghai Municipal Drug Administration and relevant technical institutions shall follow the unified command, early intervention, Based on the principles of fast, efficient, scientific approval, and meeting the actual needs of the market, according to their respective responsibilities and the provisions of this procedure, and on the premise that the standards and procedures are not reduced, carry out emergency approval work, including emergency inspection, data pre-examination, system verification, technical Review, administrative approval, production license, etc., and strengthen service guidance for applicants.

Article 5 After receiving the application for emergency examination and approval, the Shanghai Municipal Drug Administration shall arrange personnel to go to the enterprise site to investigate the product development maturity, production capacity, self-inspection capacity, system establishment, etc. According to the on-site investigation and the relevant product guarantee, the Shanghai Municipal Drug Administration, together with inspection and technical review units, as well as clinical or public health experts, will evaluate and judge the medical devices that apply for emergency approval, and timely determine whether the product is subject to emergency response. The approval is confirmed and the applicant is notified of the result.

Article 6 For medical devices that have been confirmed for emergency approval, if Shanghai Medical Device Inspection Institute is entrusted to carry out inspection, it shall organize inspection work within 24 hours after receiving the samples, and issue inspection reports in time.

Article 7 For medical devices that have been confirmed for emergency approval, the Center for Device Review of Shanghai Medical Products Administration shall designate a special person before accepting the registration application and during the technical review process to provide service guidance to the applicant throughout the process.

Article 8 For medical devices that have been confirmed for emergency approval, the Shanghai Municipal Drug Administration shall organize pre-examination services for relevant registration application materials before the applicant formally submits the registration application.

Article 9 For medical devices that have been confirmed for emergency approval, after accepting the relevant registration application materials, system verification materials, and medical device production license application materials, the Administrative Service Center of the Shanghai Municipal Drug Administration shall mark the relevant materials as "emergency approval". , and assign a special person to be responsible for the data flow on the same day.

Article 10 For medical devices that have been confirmed for emergency approval, the Center for Device Review of Shanghai Municipal Drug Administration shall organize a system inspection within 2 days after receiving the system inspection data, and make a system inspection conclusion in a timely manner.

Article 11 If the application for emergency approval of medical device registration is accepted and the payment is confirmed, the Center for Device Review of Shanghai Municipal Drug Administration shall complete the technical review within 5 days.

Article 12 For emergency approval medical device registration applications that have passed the technical review, the Shanghai Municipal Drug Administration shall complete the administrative approval within 3 days, and issue the medical device registration certificate in a timely manner.

Article 13 For the emergency examination and approval medical devices approved for registration, after receiving the relevant medical device production license application or modification application, the Shanghai Municipal Drug Administration shall, in accordance with the relevant provisions of the "Measures for the Supervision and Administration of Medical Device Production", 5 A decision on whether to issue or change the medical device production license shall be made within days.

Article 14 For emergency approval medical devices approved for listing with conditions, the validity period of the medical device registration certificate shall be the same as the completion time limit of the conditions stated in the registration certificate, which in principle shall not exceed 1 year. The registrant may apply for renewal of registration before the expiry of the registration certificate. For those who meet the requirements for renewal of registration and complete the attached conditions, the renewal of registration is granted, and the registration certificate is valid for 5 years.

Article 15 For medical devices that have been confirmed for emergency approval, within 90 days from the date of confirming the approval of emergency approval, if the applicant fails to submit the registration application according to the relevant requirements and is accepted, the emergency approval procedure shall no longer be handled in accordance with the principle. You can refer to the "Priority Approval Procedures for Class II Medical Devices in Shanghai", and give priority to review and approval after acceptance.

Article 16 The Shanghai Municipal Drug Administration shall strengthen the supervision and inspection of the emergency approval medical device production enterprises within 3 months after the relevant products are approved and the medical device production licenses of the relevant enterprises are granted or changed, supervise the enterprises to implement the main responsibility, and guarantee the products. Quality and Safety.

Article 17 This procedure will be implemented from August 1, 2022 and will be valid for 5 years.