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Circular Letter Of The Medical Device Authority

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: 

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TITLE

LANGUAGE

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 (Appendix 1-Revision 3)

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 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

MalayEnglish

1/2016

Refurbishment of Medical Device (Revision 1)

MalayEnglish

2/2016

Medical Device Procurement For Healthcare Institution (Revision 2)

Malay

3/2016

Change Of Ownership For Medical Device Registration

MalayEnglish

4/2016

Transition Period For Medical Device Labeling

MalayEnglish

5/2016

Imposition Of Charges Or Fees For Product Classification

Malay  / English

1/2017

Registration Requirement And Exemption From Labelling For Export Only Medical Device (Withdrawn)

Malay / English

2/2017

National Preparation To Ratify Minamata Convention On Mercury

Malay  / English

3/2017

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

Malay  / English

4/2017

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

MalayEnglish

1/2018

Licensing And Medical Device Registration Of Contract Manufacturer For Application Of Free Sale Certificate (Withdrawn)

 

2/2018

Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution or Any Related Facilities (Revision 1)

Malay / English

3/2018

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

4/2018

Exemption From Registration Requirement For Export Only Medical Device (Revision 1)

Malay  / English

5/2018

Additional Transition Period for Medical Device Labeling

Malay  / English

1/2019 Post-Market Responsibilities for Manufacturer and Authorized Representative (Revision 1) Malay / English

 

These circulars shall take effect immediately.

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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