The distribution of class II and/or class III medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government. Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License, and shall verify the certificates of qualified products. Enterprises distributing medical devices shall meet the following conditions:
1) Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;
2) Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;
3) Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;
The enterprise distributing 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 Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.
The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration, re-inspection and license renewal shall be conducted. mplementation 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
