Malaysia: Medical Device Authority Releases Second Edition of Medical Device Guidance for PPEs
On May 27, 2022, Malaysia’s Ministry of Health’s Medical Device Authority (MDA) released a Second Edition of Medical Device Guidance (MDG) for Personal Protective Equipment (PPE) requirements. The amendment is to the March 2022 public comment addition MDA/GD/00558.
The second edition provides guidance to healthcare facilities and establishments. Specifically, those that deal with requirements for PPE that fit the definition of a medical device in accordance with Section 2 of the Medical Device Act 2012 (ACT 737) during the medical device registration application.
Some addition of ISO Standard requirements are required. The second edition of MDA/GD/0058 benefits the manufacturer and the registrant of PPEs because it clearly stated the ISO Standard which are indispensable for the application of PPE application, this can reduce deficiency documents preparation, and timeline for registration approval. Some of the PPE it affects include:
- Coveralls: ISO 16603 (Class 5 or 6); ISO 16604 (Class 5 or 6); EN 13795; and ISO 22610 (high performance) and ISO 22612 (high performance);
- Apron: ASTM F2407 level 1 or 2; or EN 13688; and for impact strength and tear resistance: ISO 7765-1; and ISO 6383-2; If biodegradable: EN 13432; or ASTM D6400;
- Head Cover: ISO 13688.
- Shoe Cover: ISO 13688.
If you have any questions regarding medical device registration and representation in Malaysia, please contact us.