HNCA MD

Client Information Package 01/1-01/5

HNCA TAC Client
1. Certification Agreement HNCA-TAC-01/1 (Print, Initial Every Page and Sign)
2. Certification Policy HNCA-TAC-01/2 (Print , Initial Every Page and Sign)
3. Self Labeling SLP-PRO-01/3
4. E-Permit EP-PRO-01/4
5. User Manual Client UMC-DOC-01/5

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ACT 737 & MDR 2012 Documents

Kindly find the updated documents in portal.mda.gov.my

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Guidance Document under Medical Device Act 2012 ( Act 737)

These 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.

List of guidance documents:

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