Home
Home PDF Print E-mail
Article Index
Home
Page 2
Page 3
Page 4
Page 5
Page 6

 TRAINING FOR CONFORMITY ASSESSMENT BODIES: REGISTRATION OF CAB & ASSESSMENT OF GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICE (GDPMD)

Date : 13 October 2014, Monday | 9.30 am to 5.00 pm

Venue : Main Meeting Room, Medical Device Authority, Level 5, Menara Prisma, Precinct 3, 62675 Putrajaya

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 ...


UPGRADING OF LABORATORY TO A GOOD LABORATORY PRACTICE (GLP) COMPLIANCE FOR MEDICAL DEVICE TESTING

MDA DEVELOPMENT FUND

INTRODUCTION

Funding is available for testing and supporting laboratories that seek to upgrade their quality management system to a GLP-compliance status in medical device testing. The fund is provided in the form of a grant to qualified labs undertaking biological safety testing (biocompatibility) of medical devices. Compliance to GLP regulation is required to substantiate the safety of all medical devices produced, marketed and used in the country. It is therefore envisaged that the GLP-compliant laboratories would be able to enhance their capacity and know-how in providing a much needed sub-ecosystem to the medical device industry in Malaysia and elsewhere.  read more ...


REQUEST FOR PARTICIPATION: AWARENESS PROGRAM ON MEDICAL DEVICE REGULATIONS FOR HEALTHCARE FACILITIES IN HOSPITAL SULTANAH NUR ZAHIRAH, TERENGGANU http://www.mdb.gov.my/mdb/images/urgent%20%281%29.gif

Date : 14 September 2014 (Sunday)
Time : 8.30 am - 1.00 pm
Venue : Auditorium, HOSPITAL SULTANAH NUR ZAHIRAH, TERENGGANU
Zone : Timur 
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.

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 ...


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 ( Saturday, 13 September 2014 )
 
 
AWARENESS PROGRAM
Muat naik presentation slide Program Kesedaran Akta Peranti Perubatan Bersama Agensi Kerajaan (18 Ogos 2014) . Klik sini !
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
(c) 2008-2013 Medical Device Authority. http://www.mdb.gov.my     [Privacy Policy]     [Security Policy]

Best viewed using Internet Explorer 7 and Mozilla Firefox with 1024 x 768 screen resolution.