This article deals with the Medical Gas System Guidance Document. The Medical Device Authority (MDA) created this Guidance Document to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.
Registration requirements
A medical device registration application must be made in accordance with the provisions of Act 737 and in the manner specified by the Authority in the Medical Device Regulations 2012. As stated in this guidance document, a medical gas system planned for market entry must be registered as a whole system, a subsystem, or specific individual devices connected with the medical gas system. The manufacturer or authorized representative is the person responsible for registering a medical device under Act 737. The specifications are categorized as follows.
- Grouping determination
- Device risk categorization
- Essential Safety and Performance Principles
- Guidelines for showing conformance with the Common Submission Dossier Template
- Performing conformity testing
More details with regards to the registration process can be found in given source link.
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Source : Medical Device Authority, Malaysia.
