Overview

Malaysia medical device industry is booming as the Malaysian government making it conducive for global players. The country greatly relies on foreign manufacturers for high-end Medical Devices. They are regulated by Malaysian Medical Device Authority (MDA) functioning under Ministry of Health Malaysia (MoHM). The Regulatory sieving begins with classification as A, B, C or D based on risk of the device followed by review by MDA authorized conformity assessment bodies (CAB). Procuring a dependable local agent with an establishment license, and maintaining post-approval activities actively are tasks that further burden manufacturers with huge investments.

Freyr extends auxiliary support for manufacturers with Device Classification, conformity assessment for certification and extends support throughout the Regulatory process. Freyr helps foreign applicants to procure a suitable local agent with industry relevance. Freyr, with long-standing experience, effectively handles the post-marketing surveillance activity of Medical Devices in Malaysia.

 

Malaysia Market Entry for Medical Devices - Process Flow

Vietnam Medical Device Regulations

 

 

Freyr Expertise

  • Regulatory Guidance for Registration
  • Medical Device Classification
  • Malaysian Local Representation Service
  • Regulatory Support in Adhering to Good Distribution Practice Medical Devices (GDPMD)
  • Dossier/Document Compilation
  • Post-Market Surveillance

 

Summary

S.No

Regulatory Parameter

Malaysia

1

Regulatory Authority

Malaysian Medical Device Authority (MDA)

2

Regulation

Act 737, Medical Device Act 2012

3

Risk Classification

Class A

Class B

Class C

Class D

4

Regulatory Pathway

Class A

Online Application

Class B, C & D

CAB Review + Online Application

5

Authorized Representative

Malaysian Representative required

6

Fee payable

Class A

$25*

Class B

$320*

Class C

$640*

Class D

$960*

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

Conformity Assessment Body (CAB)

9

Validity of License

5 Years

10

Labelling Requirements

Schedule VI of Medical Device Rules 2012

11

Submission format

Online (MeDC@St)

12

Final Outcome

Registration Certificate

13

Timelines

1 - 9 Months

14

Language

English

*The price is as per records at the time of documentation and is subject to change.