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PUBLIC COMMENT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT GUIDANCE ON THE PRODUCT GROUPING FOR IN-VITRO DIAGNOTIC (IVD) MEDICAL DEVICES

PUBLIC COMMENT : DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT

GUIDANCE ON THE PRODUCT GROUPING FOR IN-VITRO DIAGNOTIC (IVD) MEDICAL DEVICES

 

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.mybefore 27th Mac 2020

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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@mda.gov.my

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  • Last Modified: 28 March 2020.
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