Medical device manufacturing enterprises shall not start manufacturing products before obtaining the manufacturing enterprise license. Enterprises manufacturing medical devices shall meet the following conditions.
1. Possess professional technical personnel required for the manufacture of its medical devices;
2. Possess facility and environment required for the manufacture of its medical devices;
3. Possess equipment required for the manufacture of its medical devices;
4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.
The manufacturing of class II and/or class III medical devices , requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License. The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration, re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn
