Medical Device Registration in Malaysia
DURATION : Two (2) full days
INTRODUCTION
Has your Establishment completed what is necessary in regards to Medical Device Registration Requirements under the Malaysian Medical Device Act and Regulations? Or will you cease to be able to sell your medical devices when the regulations come into force? These are some of the questions this course answers whilst providing strategies and solutions to Establishments affected. Participants will identify as to whether their company’s products need to be registered and the essential steps required.
For those medical devices qualified for Fast Track approach, what are the necessary documentary evidence required and what should these contain? This course also covers what are the expectations of the MDA on medical device registration and strategies for you successfully register and maintain registration of your medical device.
COURSE OBJECTIVES / OUTLINE
INTRODUCTION
Has your Establishment completed what is necessary in regards to Medical Device Registration Requirements under the Malaysian Medical Device Act and Regulations? Or will you cease to be able to sell your medical devices when the regulations come into force? These are some of the questions this course answers whilst providing strategies and solutions to Establishments affected. Participants will identify as to whether their company’s products need to be registered and the essential steps required.
For those medical devices qualified for Fast Track approach, what are the necessary documentary evidence required and what should these contain? This course also covers what are the expectations of the MDA on medical device registration and strategies for you successfully register and maintain registration of your medical device.
COURSE OBJECTIVES / OUTLINE
- Overview of Medical Device Registration Requirements under the Malaysian Medical Device Act & Regulations
- What are medical devices exempted from registration?
- Fast Track Medical Device Registration – Quick Fix or Cure? Does your medical device qualify and what do you need to do?
- Steps in conducting Medical Device Registration
- Determine Product Risk Classification
- Identify Medical Device Grouping
- Understand Conformity Assessment by the Establishment / Manufacturer
- Selection of Conformity Assessment Procedures and Conformity Assessment Bodies (CAB’s)
- How to develop and maintain Technical Documentation and the Common Submission Dossier Template (CSDT)
- Quality Management System Requirements
- Post Market Surveillance & Vigilance Requirements
- Medical Device Registration evaluation by the MDA
- MeDC@St – what, how and when?
- Strategies for maintain your medical device product registration
TARGET AUDIENCE
PRE-REQUISITE
Knowledge on the Malaysian Medical Device Act, Regulations and GDPMD is preferable.
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
- Quality Managers
- Regulatory Affairs Managers
- Designated Persons / Management Representatives
- Auditors of Medical Device manufacturing firms (internal and external)
- Cross functional team members of implementation project
PRE-REQUISITE
Knowledge on the Malaysian Medical Device Act, Regulations and GDPMD is preferable.
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347