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 REGISTRATION OF MEDICAL DEVICE UNDER MEDICAL DEVICE ACT 2012 (ACT 737) read more ..

 


GOOD LABORATORY PRACTICE (GLP) COMPLIANCE FOR MEDICAL DEVICE TESTING MDA DEVELOPMENT FUND  read more  ..


NOTIFICATION OF LOW RISK MEDICAL DEVICES http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif 

Referring to the Circular Letter No. 3 Year 2014 (Exemption of Medical Device from Registration), please be informed that all Class A medical devices which are non-active, non-sterile and has no measuring function are exempted from registration requirements. read more...

ATTENTION!http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif 

LATEST INFORMATION ON CONFORMITY ASSESSMENT BODY

For further information, please click here


UPDATE ON CIRCULAR LETTER NO. 3 YEAR 2014: EXEMPTION OF MEDICAL DEVICE FROM REGISTRATIONhttp://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif 

In view of the problems faced by stakeholders, and our effort to facilitate the industry, Medical Device Authority (MDA) has taken into account the issues raised. 

In conjunction with feedback from stakeholders and the medical device industry players, we are pleased to inform that MDA has decided to abolish the List of Low-risk medical devices Exempted from Registration (Appendix 1) in Circular Letter No. 3 Year 2014, due to the frequency of evolving medical device. 

The exemption of low-risk medical device from registration shall be for all Class A medical devices that are non-active, non-sterile, and have no measuring function.  

This circular shall take effect immediately. To download, please click here


CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif

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. read more ...


Last Updated ( Friday, 27 March 2015 )
 
 
ONLINE SERVICES

is a web-based Online Application System for Establishment Licensing, Medical Device Registration and Export Permit.

CIRCULAR LETTER

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: read more ...

GUIDELINE DOCUMENTS
GUIDANCE DOCUMENTS

Guidance Documents are prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the establishment license and medical device registration applications required under the Medical Device Act 2012 ( Act 737). CLICK HERE!

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