welcome central advisory system - iso consultancy singapore & malaysia
welcome to central advisory system about central advisory system central advisory system value central advisory system services central advisory system customers central advisory system achievements enquiry to central advisory system contact central advisory system central advisory system sitemap
Login to Central Advisory System Email Server
ISO 9001
ISO 14001
ISO 45001
ISO 22000
ISO 13485
ISO 17025
TS 16949
  Click for more..
Medical Device Regulation

Central Advisory System Sdn Bhd, Malaysia is the pioneer who provides consultancy & training to local and oversea industries on medical devices requirements.


Background: Cabinet Decisions

  • Cabinet approval on the development of Medical Device Regulatory Program: 16 Feb 2005
    • Development of MD Bill & subsidiary legislations
    • Establishment of an organization to implement
    • Development of MD Registration & Surveillance/Vigilance System
  • Establishment of Medical Devices Bureau: August 2005

Proposed Medical Device Regulation

  • Aims of regulation
  • Scope of regulation
  • Elements of regulation
  • Definition of medical device
  • Classification of medical device
  • Safety and performance of medical device
  • Good manufacturing principles
  • Packaging and labeling
  • Conformity assessment
  • Pre-market requirements
  • Requirements for placement on the market
  • Register
  • Post-market requirements
  • Export certificate
  • Enforcement and investigation
  • Ancillary matters

Aims of regulation

  • Ensure public health and safety
    • Assurance for safety and performance
    • Timely access for beneficial medical technologies
    • Prevent dumping ground for unsafe and defective medical devices
  • Facilitate trade and industry
    • Conducive environment for medical devices manufacturing
    • Facilitate trade and export
    • Promote health tourism

Medical device classification

Classification of medical devices:
A medical device shall be classified in accordance with the level of risk it poses

Conformity Assessment Procedure

New Requirement


  Link to Food Vigilance News
  Asia Pacific
  Click for more..



Copyright 2008 - 2009 Central Advisory System Sdn Bhd (781111-P). All Rights Reserved. Best viewed at 1024 x 768 resolution with IE 5.x.