SECOND EDITION GUIDANCE DOCUMENT MDA/GD/0005: GENERAL MEDICAL DEVICE - GROUPING
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.
This guidance document is updated to provide guidance to determine the appropriate grouping for medical devices in the medical device registration application and separate the grouping requirements for IVD medical devices.
This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-
- Medical Device Act 2012 (Act 737);
- Medical Device Regulations 2012;
- The Medical Device (Advertising) Regulations 2019; and
- The Medical Device (Duties and Obligations of Establishments) Regulations 2019;
To view the guidance document, CLICK HERE