1, personnel:
(1) Full-time quality management personnel of medical device enterprises of category III shall have college degree or above or intermediate title or above;
(2) The third category of medical device enterprises shall not be less than1000000 yuan;
(3) The quality inspectors of the third category medical device enterprises should have college education or above or intermediate titles;
(4) Enterprises engaged in the retail of domestic therapeutic products or three types of implanted devices should be equipped with personnel with certain medical qualifications.
2. Business premises:
(1) place of business:
General enterprises use an area of not less than 40 square meters, residential buildings cannot be used as business premises, and retail enterprises must be facade houses;
(2) Storage conditions:
General enterprises use an area of not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises;
(3) Enterprises engaged in disposable aseptic, implantable and other special medical devices must have their own warehouses, and the storage conditions should meet the requirements of product standards.
Legal basis: Article 23 of the Company Law of People's Republic of China (PRC).
The establishment of a limited liability company shall meet the following conditions:
(1) Shareholders meet the quorum;
(2) The capital contribution subscribed by all shareholders in accordance with the Articles of Association;
(3) Shareholders * * * agree to formulate the Articles of Association;
(4) Having a company name and establishing an organization meeting the requirements of a limited liability company;
(5) Having a company domicile.