The Medical Device Authority (MDA) has released the Guidance Document, MDA/GD/0005, Second Edition, entitled “General Medical Device – Grouping” to assist the industry and healthcare professionals in achieving compliance with the Medical Device Act (Act 737) and its associated regulations.
The guidance document has been updated to offer direction on determining the appropriate grouping for medical devices in the medical device registration application, with specific guidance on grouping requirements for IVD (In Vitro Diagnostic) medical devices. For instance:
A) Section 4.3.5 outlines Special grouping for In Vitro Fertilisation (IVF) Medical Devices.
B) Section 4.3.6 specifies grouping for hearing aids.
This Guidance Document must be reviewed in conjunction with existing Malaysian laws and regulations, including, but not limited to, the following
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
- The Medical Device (Advertising) Regulations 2019
- The Medical Device (Duties and Obligations of Establishments) Regulations 2019
Further information on this regulation can be accessed here: General Medical Device Grouping (mda.gov.my).
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.