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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: 

NO 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 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  Malay
 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
 1/2017Registration Requirement And Exemption From Labelling For Export Only Medical DeviceMalay  / English
 3/2017

Implementation And Enforcement Of Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products

 Malay  / English

These circulars shall take effect immediately.
Last Updated ( Tuesday, 18 April 2017 )
 
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