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Circular Letter Of The Medical Device Authority PDF Print E-mail

Circular Letter Of The Medical Device Authority

In view of the problems faced by stakeholders, and an effort to facilitate the industry, Medical Device Authority (MDA) has taken into account the issues raised. After much deliberation the Authority has decided to alleviate and remove all obstacles in the implementation of Medical Device Act (Act 737) as part of our continued role in facilitating the industry.

We are pleased to inform that MDA has decided on new policies to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737).

The policies are as follows: 




1 / 2014

Establishment As Authorised Representative And Establishment Undertaking Multiple Activities

Malay  / English

2 / 2014

Conformity Assessment Procedures For Medical Device Approved By Recognised Countries

Malay / English

3 / 2014

Exemption Of Medical Device From Registration Requirements
Note:The Circular Letter will no longer effective. Please Refer to Medical Device Exemption 2016

Malay  / English

4 / 2014

Medical Device For The Purpose Of Export And Transit And Medical Device For Import/Export   From/To Countries Without Diplomatic Ties With Malaysia

Malay  / English

5 / 2014

Certification Of Good Manufacturing Practice (GMP) For The Purpose Of Obtaining Establishment License

Malay  / English

1 / 2016

Refurbishment of Medical Device 

Malay  / English

2 / 2016

Medical Device Procurement For Healthcare Institution


3 / 2016

Change Of Ownership For Medical Device Registration

Malay  / English

4 / 2016

Transition Period For Medical Device Labeling

Malay  / English

5 / 2016

Imposition Of Charges Or Fees For Product Classification

Malay   / English


Registration Requirement And Exemption From Labelling For Export Only Medical Device (Withdrawn)

Malay  / English


National Preparation To Ratify Minamata Convention On Mercury

Malay   / English


Implementation And Enforcement Of Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products (Revision 1)

Malay    / English


Recognition Of Institute For Medical Research (IMR) To Provide The Report Or Data Of Clinical Evidence Or Performance Evaluation For The Purpose Of Conformity Assessment By Conformity Assessment Body

Malay  / English


Licensing And Medical Device Registration Of Contract Manufacturer For Application Of Free Sale Certificate (Revision 1)

Malay  / English


Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution

Malay   / English


Recognition And Listing Of Institute Or Laboratory Which Is Capable To Carrying Out Clinical Evidence Or Performance Evaluation For The Purpose Of Conformity Assessment

Malay   / English


Exemption From Registration Requirement For Export Only Medical Device

Malay   / English

These circulars shall take effect immediately.
Last Updated ( Monday, 04 June 2018 )
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