Part 3 Good Manufacturing Practices for Medical Devices
Chapter 1 General Provisions
In this Part, standards related to the design, development, production, installation, and servicing of medical devices are prescribed in accordance with the contents of medical device quality management system of the International Standard Organization (ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes).
The terms used in this Part are defined as follows:
(1) Active medical device: means a medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;
(2) Active implantable medical device: means an active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;
(3) Implantable medical device: means a medical device intended to be totally or partially introduced into the human body or a natural orifice, or 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 which can only be removed by medical or surgical intervention;
(4) Advisory notice: means a notice issued by the manufacturer in accordance to the regulations of central competent health authority, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in the use of a medical device, the modification of a medical device, the return of the medical device to the organization that supplied it, or the destruction of a medical device;
(5) Customer complaint: means a written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.
For Class 2, Class 3, and Class 1 medical devices that are not listed as non-sterile or without a measuring function under Attachment 2 of the Regulations Governing Management of Medical Devices, their manufacturers shall comply with the requirements in Chapter 2 of this Part.
For Class 1 medical devices that are listed as non-sterile or without a measuring function under Attachment 2 of the Regulations Governing Management of Medical Devices, their manufacturers shall comply with the requirements in Chapter 3 of this Part.
Requirements in Chapter 3 of this Part shall be implemented one year after the date of promulgation.