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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

 
 
Register
 
 
New Requirement
- MEDICAL GEAR TO BE OF TOP GRADE
 

 

   
 
   
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