The Medical Device Authority (MDA) regulations created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) laws and requirements. The new recommendation updates the WHO Recommendations Table in Annex A on the use of a mask or respirator in a healthcare setting based on the transmission scenario, target population, setting, activity, and type.
The following rules and regulations, among others, are among the ones now in effect in Malaysia and should be read in combination with this guidance document
- Medical Device Act 2012 – Act 737
- Medical Device Regulations 2012
- Medical Device Duties and Obligations of Establishments Regulations 2019
- Medical Device Advertising Regulations 2019
Regardless of the circumstances outlined in this guidance document, MDA reserves the right to make inquiries about materials or information or to specify terms that aren’t explicitly covered here but are deemed essential for regulatory control.
MDA has worked very hard to make sure that this guideline material is accurate and comprehensive. The written law should prevail if there is any inconsistency between the provisions of this text and any written law.MDA maintains the right to sometimes change any aspect of the instructions.
Please see this link for further details on “Third Edition Guidance Document Medical Face Mask and Respirator (MDA/GD/0033)“
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Source: MDA Guidance
