The following conditions must be met in order to start a Class II medical device manufacturing enterprise:
(a) The person in charge of the enterprise shall have a college degree or above or a junior title or above.
(B) the person in charge of the quality inspection organization should have a college degree or above, or intermediate title or above.
(C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
(d) the enterprise should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing space and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Expanded:
Application process
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration upon receipt of the application, shall be dealt with according to the following circumstances:
(a) the application does not fall within the scope of competence of the department, it shall immediately make a decision of inadmissibility, and inform the applicant to the The relevant administrative organs to apply;?
(ii) application materials can be corrected on the spot, the applicant shall be allowed to correct on the spot;?
(c) If the application materials are incomplete or do not meet the formal examination requirements, the applicant shall be issued a Notice of Corrective Material on the spot or within five working days, informing the applicant in one go of all the contents that need to be corrected, and in case of any delay, the application shall be deemed to have been accepted as of the date of receipt of the application materials;?
(4) If the application materials are complete and meet the requirements for formal examination, or if the applicant submits all the supplementary application materials in accordance with the requirements, the application will be accepted.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the application for the start-up of medical device manufacturers, should be issued with the department's acceptance of the special seal and date of the "acceptance of the notice" or "inadmissibility of the notice".
After the review meets the requirements, to make a written decision to grant a license, and within 10 working days to send the "medical device manufacturer license". After review does not meet the requirements, make a written decision not to issue a license, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or to bring an administrative lawsuit.
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