This set of regulations is established pursuant to Article 22 Paragraph 4 of the Medical Device Act (hereafter referred as the Act).

In this Part, standards related to the facilities, equipment, organization and personnel, production, quality control, storage, distribution, handling of customer complaints and other matters of manufacturers of medical devices are prescribed with reference to the ISO 13485: Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes published by the International Standard Organization.

The terms used in this Regulations are defined as follows:
(1) Advisory notice: It refers to supplementary information or recommended measures issued by the manufacturers, after delivery of medical devices, for the usage, modification, recall, destruction or other related matters of the medical devices;
(2) Customer complaint: It means a message showing dissatisfaction in written, electronic or oral forms related to the features, quality, usability, reliability, safety, fuctionality or performance of a medical device on the market;
(3) Implantable medical device: It means a medical device intended to be totally or partially introduced into the human body or a natural orifice, to replace an epithelial surface or the surface of the eye, by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and can only be removed by medical or surgical intervention;
(4) Post-marketing surveillance: It refers to the systematic collection and analysis by the manufacturer of the actual user experience of the medical devices that have been listed;
(5) Product: It refers to the output of the operation process related to the manufacturing of the medical devices, including service, software, hardware and processing materials;
(6) Risk management: It refers to systematic application of management policies, procedures, and practices on the analysis, evaluation, and control of risks;
(7) Sterilization barrier system: It refers to the minimum package that prevents ingress of microorganisms and allow aseptic presentation of the product at the point of use.