enclosure1

Medical device registrant of Guangdong Drug Administration Administrative regulations on extended inspection of recorders Draft for comments

Chapter I  General

Article 1 Legislative purpose  To ensure the quality and safety of medical devices,Ensuring human health and life safety,Promote the development of medical device industry,according to Regulations on the supervision and administration of medical devices Order of the State Council No739number Administrative measures for registration and filing of medical devices Order of the State Administration of market supervision No47number Administrative measures for registration and filing of in vitro diagnostic reagents Order of the State Administration of market supervision No48number Measures for the supervision and administration of medical device production Order of the State Administration of market supervision No53number ,Combined with the actual situation of our province,This regulation is formulated.

Article 2   definition The term "extended inspection" mentioned in these Provisions refers to that the drug regulatory department is the registrant of medical devices for comprehensive evaluation Filed by: hereinafter referred to as Registrant Filed by: Conformity and effectiveness of quality management system,Development of medical devices Production and other activities: inspection activities carried out by units and individuals providing products or services.

Article 3   Scope of application This regulation is applicable to the extended inspection activities in the field of medical devices carried out by drug regulatory departments at all levels in Guangdong Province.

Article 4   General requirements Personnel performing extended inspection,It should be the administrative law enforcement personnel of medical devices Personnel who have obtained the inspector qualification according to law or other personnel authorized by this inspection.The registrant shall be kept confidential Filed by: Business secrets of the inspected units and individuals.

The inspected units and individuals shall cooperate with the extended inspection,No concealment refuse Obstruct,The relevant documents and materials provided shall be authentic complete accuracy.

Article 5   Division of authority Guangdong Provincial Drug Administration hereinafter referred to as Provincial Bureau Be responsible for the supervision and management of extension inspection.The departments responsible for drug supervision and administration of the local people's governments at or above the county level shall be responsible for the specific implementation of the extended inspection.

Article 6 Inspection method: The extended inspection can take the form of on-site inspection or online remote inspection.

Chapter II  start-up

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