| Medical Device Regulation |
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Central Advisory System Sdn Bhd, Malaysia is the pioneer who provides consultancy & training to local and oversea industries on medical devices requirements. |
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Background: Cabinet Decisions |
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- 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
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Proposed Medical Device Regulation |
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- 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
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- 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
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Aims of regulation |
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- 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
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Medical device classification |
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Classification of medical devices:
A medical device shall be classified in accordance with the level of risk it poses |
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Conformity Assessment Procedure |
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| Register |
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| New Requirement |
| - MEDICAL GEAR TO BE OF TOP GRADE |
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