According to paragraph 1, Article 22 of the "Medical Devices Act", the medical device manufacturers shall establish a medical device quality management system governing the on-site facilities, equipment, organization and personnel, production, quality control, storage, logistics, customer complaints, and other matters and shall comply with the "Medical Device Quality Management System Regulations".

Medical device manufacturers shall establish a medical device quality management system in accordance with the provisions of the regulations set forth in the preceding paragraph, and the manufacture may only begin after receiving a compliance inspection by the central competent authority and obtaining a manufacturing license. However, product items that are exempt from obtaining a manufacturing license would be announced by the central competent authority.

In addition, according to Article 78 of the "Medical Device Quality Management System Regulations", the manufacturers engaged in producing only the items as listed in Annex (applicable for essential application mode), shall establish medical device file according to each type or device or series of devices. Each manufacturer shall also implement procedures for control of records, complaint handling as well as corrective and preventive actions.

The manufacturer mentioned in the preceding paragraph, may not be subject to other provisions of this part of these Regulations, except for the provisions of Article 11, Article 12, Article 13, Article 47, Article 55, Article 63, Article 64, Article 69, Article 76 and Article 77.

 

Create a user account on the "Medical Device Quality Management System application platform" and submit the application online.