What is the standard for Class C medical device registration in Malaysia?

For Class C medical device registration in Malaysia, the primary standards and regulations to follow are outlined by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. These regulations align with international standards to ensure safety and effectiveness of medical devices.

Key Standards and Regulations

Medical Device Act 2012 (Act 737)
- This is the principal legislation governing medical devices in Malaysia. It establishes the framework for regulating medical devices and includes provisions for device registration, compliance, and enforcement.
Medical Device Regulations 2012
- These regulations provide detailed requirements for the registration, classification, and compliance of medical devices. They cover various aspects such as technical documentation, risk management, and conformity assessment.
Common Submission Dossier Template (CSDT)
- This template is used for organizing and submitting technical documentation for medical device registration. It includes sections for device description, clinical evidence, risk management, and manufacturing information.
ISO Standards
- ISO 13485:2016: This is the standard for Quality Management Systems (QMS) for medical devices. It specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
- ISO 14971:2019: This standard provides guidelines for risk management processes for medical devices. It helps manufacturers identify, evaluate, and control risks associated with medical devices.
- ISO 10993: This series of standards covers the biological evaluation of medical devices. It includes guidelines for assessing the biocompatibility of devices in contact with the human body.
Conformity Assessment Standards
- Full Quality Assurance (FQA) and Type Examination: Depending on the device, it must undergo conformity assessment procedures conducted by a recognized Conformity Assessment Body (CAB). This includes audits and evaluations to ensure the device meets required standards.
Essential Principles of Safety and Performance
- Compliance with essential principles outlined in the regulations, which include ensuring the device is safe, effective, and performs as intended without posing unacceptable risks to users.

Summary of Standards for Class C Medical Devices

Medical Device Act 2012 (Act 737)
Medical Device Regulations 2012
Common Submission Dossier Template (CSDT)
ISO 13485:2016 (Quality Management Systems)
ISO 14971:2019 (Risk Management)
ISO 10993 (Biological Evaluation)
Conformity Assessment Procedures (FQA and Type Examination)
Essential Principles of Safety and Performance

By adhering to these standards and regulations, you can ensure that your Class C medical device meets the requirements for registration and compliance in Malaysia.