Understanding the Medical Device Regulatory Pathway in Malaysia

Online Training Id: RP-M-001



USD 499.00

USD 499.00

This training course describes the regulatory framework and the general pathway for medical device registration in Malaysia.
The course begins with an overview of the regulatory pathway in Malaysia with an emphasis on the current regulations implemented by the authorities.

We work through the basics of each step of the registration process and explain how medical device dossiers are compiled to conform to Malaysian regulations and are submitted online for approval to the Ministry of Health. The execution of all work within the main workflow will be covered with details of tasks, assessments, timelines and costs.

The course will provide you with a good insight into the Malaysian regulatory system and sound knowledge of registration.

Learning Objectives: 

  • Understanding the regulatory framework in Malaysia
  • Understanding the general pathway for medical device registration in Malaysia

Who Should Enroll: 

Regulatory Affairs, Local Authorized Representative, Medical Device Manufacturers, Medical Device Distributors, Healthcare Professionals, Medical Device Practitioners, Investors in Medical Device Sector

Full Rebate from Us!

If you engage Andaman Medical within 1 year for regulatory services such as product registration and local representation in Malaysia, the payment for this program will be offset against any future invoices.


Tan Shouzheng 

Shouzheng is a regulatory consultant in Andaman Medical Bridge Sdn. Bhd. with a thorough specialized knowledge of regulations and product registration of medical devices in Malaysia.

He holds a Bioprocess Engineering degree from University Malaysia Perlis (UniMAP). Shouzheng has comprehensive experience in clinical data evaluation, technical data interpretation and good knowledge of medical devices industry,  as well as post-market surveillances.



Online Training Highlights
Duration: 60 mins
Released On: 09/19/2019
Downloadable Resources: 
Watch a Demo
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contact@andamanmed.com

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