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PUBLIC COMMENT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT NOTIFICATION FOR CUSTOM-MADE MEDICAL DEVICE

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);

b) Medical Device Regulations 2012; 

c) Medical Device (Duties and Obligations of Establishments) Regulations 2019; and

d) Medical Device (Advertising) Regulations 2019.


This draft document is open for comment and feedback. Please submit your feedback form to anissuhaila [AT] mda [DOT] gov [DOT] my before 9 November 2022.

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.

 

 

 

Updated: 31st October 2022

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb [AT] mda [DOT] gov [DOT] my

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