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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: read more ...


TRAINING ON THE REQUIREMENTS OF ESTABLISHMENT LICENSING, GENERAL MEDICAL DEVICE AND IN-VITRO DIAGNOSTIC (IVD) REGISTRATION UNDER THE MEDICAL DEVICE ACT 2012 (ACT 737) - SARAWAK & SABAH 

PROGRAM OVERVIEW 
This training is aimed to :
  • To comprehend the Medical Device Act 2012 (Act 737)
  • To understand the process of establishment licensing requirements, registration of general medical device and IVD medical device. Read more...

TRAINING ON MEDICAL DEVICE REGULATION AND  REGISTRTION OF IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE UNDER MEDICAL DEVICE ACT 2012 

PROGRAM OVERVIEW

This training is aimed to :

  • To comprehend the Medical Device Regulations 2012;
  • To understand the process of  IVD Medical Device  Registration. Read more ...

IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE PRODUCT REGISTRATION VIA MeDC@St ONLINE SYSTEM 

We would like to announce that the module for In-Vitro Diagnostic (IVD) medical device registration has been incorporated in MeDC@St online system. With this module, you can now start to make online registration of IVD medical device via MeDC@St.

We have also developed a guideline on ‘How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Medical Device Act 2012 (Act 737)’ to provide information and explanation on how to register IVD medical device via MeDC@St. Read more ...  

 


Last Updated ( Tuesday, 08 July 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!

TRAINING & EVENTS
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