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NOTIFICATION OF LOW RISK MEDICAL DEVICES 
 
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 

NOTICE OF SUSPENSION (BSI SERVICES (MALAYSIA) SDN. BHD.)

This is to inform that BSI Services (Malaysia) Sdn Bhd,  registered  as a Conformity Assessment Body under Section 10 of the Medical Device Act 2012 (Act 737) bearing registration number MDA/CAB-005 is now suspended with immediate effect to perform any conformity assessment activity until further notice. 


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 !


TRAINING FOR CONFORMITY ASSESSMENT BODIES: REGISTRATION OF CAB & ASSESSMENT OF GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICE (GDPMD) http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif

ATTENTION!

The TRAINING FOR CONFORMITY ASSESSMENT BODIES: REGISTRATION OF CAB & ASSESSMENT OF GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICE (GDPMD) scheduled for Monday 13th October 2014 has been postponed to a later date due to unforeseen circumstances. We will inform the new date as soon as possible.

Sorry for all inconveniences. 

PROGRAM OVERVIEW

This training program is aimed to educate conformity assessment bodies (CABs) on:

  • The requirements for registration of CAB under Section 10 of Act 737; and
  • The assessment of Good Distribution Practice for Medical Device (GDPMD) as specified under MDA/RR No 1: July 2013

 read more ...


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 ( Tuesday, 09 December 2014 )
 
 
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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