The requirements for registration of a Class III medical device company include the following:
Registered Capital Requirements: the registered capital of a Class III medical device company should be not less than RMB 10 million.
Personnel requirements: the company should be equipped with medical device quality management personnel, professional and technical personnel with relevant qualifications and experience to meet the company's operational and development needs.
Place requirements: the company shall have a place that meets the requirements for the production and operation of medical devices, including office space, production space, warehouse and so on.
Equipment requirements: the company should have equipment that meets the requirements of medical device production and operation, including production equipment, testing equipment and so on.
Documentation requirements: The company shall establish a comprehensive document management system, including quality manual, program documents, operating instructions, etc., to ensure that the company's operation and management comply with relevant regulations and standards.
In summary, the registration requirements for Class III medical device companies include registered capital, personnel, premises, equipment and documents, etc., which require the company to have the appropriate qualifications and conditions to ensure that the company's operation and management comply with relevant regulations and standards.
Legal basis:
The Regulations for the Supervision and Administration of Medical Devices stipulate that, to engage in the operation of Class III medical devices, the operating company shall apply for a license to the municipal people's government of the district in charge of the supervision and management of drugs. Application for permission to operate Class III medical devices shall be submitted to the following information:
Copy of business license and organization code certificate;
Copy of identity certificate of legal representative, responsible person of the enterprise, responsible person for quality, education or title certificate;
Organizational and departmental setup description;
Business scope, business mode description;
Business premises, warehouse address of the geographic location of the map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies;
Articles of Incorporation and shareholders' resolutions;
Business facilities, equipment directory;
Business quality management system, work procedures and other documents directory;
Authorization of the operator certificate;
Authorization of the operator certificate;
Original application form.