What are the registration requirements for medical device companies?

Legal analysis: 1. The company needs to have quality management institutions or quality management personnel suitable for its business scope and scale, and the quality management personnel should have relevant professional qualifications or titles recognized by the state. It should be noted that, in addition to relevant professional qualifications or titles, the quality leaders of the three types of medical device enterprises should also have more than 3 years of experience in quality management of medical device operation;

2. Having business and storage places suitable for the business scope and scale. If the third or second kind of in-vitro diagnostic reagents are operated, the use area of the business premises shall not be less than 100 square meters, the use area of the warehouse shall not be less than 60 square meters, and the volume of the cold storage shall not be less than 20 cubic meters (different policy requirements in different regions). A company that entrusts all other medical device storage enterprises shall not set up warehouses;

3. It has a quality management system suitable for the medical devices it operates;

4. Having the professional guidance, technical training and after-sales service capabilities suitable for the medical devices operated, or agreeing to provide technical support from relevant institutions. In addition to these, enterprises engaged in the third kind of medical device management should also have a computer information management system that meets the requirements of medical device management quality management to ensure the traceability of the products they operate.

The information required for registration generally includes: copies of the front and back of the shareholder, legal person and financial identity card, the proportion and duration of the shareholder's investment, the company's business scope, registered address, house lease agreement and a copy of the real estate license; Shareholders, legal persons and financial contact information, articles of association, resolutions of shareholders' meeting, application for registration of company establishment, letter of commitment for enterprise notification, etc.

Legal basis: Article 6 of the Company Law of People's Republic of China (PRC) shall apply to the company registration authority for registration of establishment. Those that meet the conditions for establishment as stipulated in this Law shall be registered as limited liability companies or joint stock limited companies respectively by the company registration authority; Those who do not meet the conditions for establishment as stipulated in this Law shall not be registered as a limited liability company or a joint stock limited company.

Where laws and administrative regulations stipulate that the establishment of a company must be approved, the approval procedures shall be handled according to law before the company is registered.

The public may apply to the company registration authority to inquire about the registered items of the company, and the company registration authority shall provide inquiry services.