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Medical device business record license
Medical device business record/license
Medical device business record/license is a drug.Supervision and management departmentAccording to the application of the medical device business enterprise, in accordance withStatutory procedures, the operating conditions and management capabilities required for the products it intends to operate.systematic evaluationThe process of deciding whether to agree to its application. To engage in medical device business activities, one shall comply with the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Business, and the medical device business quality management standards to ensure that the medical device business process information is true, accurate, complete and traceable. Many domestic companies have obtained medical device business filing certificates/licenses, which can be queried through the State Drug Administration:https://www.nmpa.gov.cn/datasearch/home-index.html?itemId=ff80808183cad7500183cb66fe690285#category=ylqx
Medical device business supervision mode
The management of medical devices shall be classified according to the risk degree of the products. The third category of medical devices shall be subject to license management, the second category of medical devices shall be subject to record management, and the first category of medical devices shall not require license and record. The supervision methods and departments are shown in the following table:
Project | Operating a class of equipment | Operating Class II Devices | Operating three types of equipment |
License/Filing Certificate | / | Filing | Licensing |
Regulatory/Approval Department | / | District-level municipal drug supervision and administration departments | District-level municipal drug supervision and administration departments |
Medical Device Business Filing/Licensing Conditions
Agency personnel:Quality management institutions or quality management personnel that are compatible with the scope and scale of business, and the quality management personnel shall have relevant professional qualifications or professional titles;
Business premises:Business premises appropriate to the scope and scale of business;
Storage requirements:Storage conditions appropriate to the scope and scale of operation may be set up across regions and third-party warehousing and logistics may be entrusted;
quality management system:A quality management system that is compatible with the medical devices being operated;
Technical personnel:Quality management institutions or personnel for professional guidance, technical training and after-sales service suitable for the medical devices under operation;
computer information management system:It should have a computer information management system that meets the requirements of the medical device business quality management system to ensure that the products operated can be traced back. (Three types of business license must have, two types of business record to encourage to have)
Medical Device Business Filing/Licensing Process
1. Establishment of the Company:Registered company, business license, clear medical equipment business scope.
2. Software and hardware preparation:Business premises, equipment, personnel, computer systems (required for three types of licenses and encouraged for two types of records), quality management system, warehousing (third-party warehousing and logistics companies can be set up or entrusted across regions).
3. Submit Application:The operating enterprise shall submit an application to the department in charge of drug supervision and administration at the city level divided into districts where it is located.
4. On-site verification of operation quality management system: After the application for the third type of business license is accepted, the regulatory department will conduct on-site system verification within 20 working days; after the application for the second type of business record is accepted (if necessary), the regulatory department will conduct on-site system verification within three months.
5. Certificate:The three-class business license is valid for five years, and the second-class business record certificate is not valid.
OUR SERVICES
Identification of applicable regulations:Identify personnel qualifications, product storage, computer systems and other requirements based on the product category of the business.
business quality management system established:GSP system establishment, personnel training, on-site verification preparation and response counseling.
Business license/filing declaration:Guidance on business license/filing declaration materials, systematic declaration, review and follow-up, submission of supplementary materials.
Cross-regional storage and transportation services:Coordinate and provide multi-temperature zone warehousing and transportation services that meet the requirements of GSP for medical devices, and real-time monitoring by computer traceability system.
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
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