Medical Device Authority releases draft amendment or second edition of Medical Device Guidance for PPEs
Malaysia’s Ministry of Health’s Medical Device Authority (MDA) released a draft amendment or second edition of Medical Device Guidance (MDG) for Personal Protective Equipment (PPE) requirements. The amendment is to the September 2021 first addition MDA/GD/00558.
The draft document 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 ISO Standard requirements are no longer required. The amendment or second edition of MDA/GD/0058 benefits the manufacturer and the registrant of PPEs because it reduces tests, costs, and time. Some of the PPE it affects include:
- Clothing for protection against contact with blood and body fluids: ISO 16603, 16604:2004.
- Surgical drapes, gowns, and clean air suits, used as medical devices, for patients, clinical staff and equipment: ISO 22610.
- Clothing for protection against infectious agents: ISO 22612.
- Coveralls, apron, head cover, and shoe cover.
The due date for public comment on the draft amendment guideline is March 25, 2022. Stakeholders who would like to give their feedback and comments can send them to email@example.com
If you have any queries regarding the requirements for PPE as medical devices or our services for medical device registration and representation in Malaysia, contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.