PUBLIC COMMENT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT GUIDANCE ON THE GENERAL MEDICAL DEVICE

PUBLIC COMMENT

DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT

GUIDANCE ON THE 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 shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-

a) Medical Device Act 2012 (Act 737); and

b) Medical Device Regulations 2012.

This draft document is open for comment and feedback.

Please [CLICK HERE] to download the guidance document.

Please [CLICK HERE] to download the form to give comment and feedback.

Please submit your feedback form to norfazila@mda.gov.my before 28 January 2021.

PUBLIC COMMENT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT GUIDANCE ON THE GENERAL MEDICAL DEVICE - GROUPING