The registration requirements of three types of medical device companies include the following aspects:
Requirements for registered capital: The registered capital of Class III medical device companies shall not be less than RMB100000.
Personnel requirements: the company should be equipped with medical device quality management personnel and professional and technical personnel with relevant qualifications and experience to meet the business development needs of the company.
Location requirements: The company should have a location that meets the requirements of medical device production and operation, including office space, production site, warehouse, etc.
Equipment requirements: the company should have equipment that meets the requirements of medical device production and operation, including production equipment and testing equipment.
Document requirements: The company shall establish a complete document management system, including quality manuals, procedure documents and work instructions. To ensure that the company's operation and management comply with relevant laws and standards.
To sum up, the registration requirements of the three types of medical device companies include registered capital, personnel, places, equipment and documents. The company is required to have corresponding qualifications and conditions to ensure that the company's operation and management comply with relevant laws and standards.
Legal basis:
The Regulations on the Supervision and Administration of Medical Devices stipulates that those who engage in the operation of Class III medical devices shall apply to the pharmaceutical supervisory and administrative department of the municipal people's government with districts for permission. To apply for the business license of Class III medical devices, the following materials shall be submitted:
Copy of business license and organization code certificate;
A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;
Description of organizational structure and department setting;
Description of business scope and mode of operation;
A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address;
Articles of association and resolutions of the shareholders' meeting;
Catalogue of business facilities and equipment;
Catalogue of documents such as management quality system and working procedures;
The authorization certificate of the agent;
Original application form.