JOYLEE Medical Pro Fingertip Pulse Oximeter is Medical Device Authority (MDA) certified.
What is Medical Device Authority (MDA)?
Malaysia is currently one of the main countries in ASEAN that imports most of the medical device for domestic use. Therefore Medical Device Authority (MDA) was formed in 2012 for the companies to register their medical device to MDA as a part of Ministry of Health (MoH).
The present MDA guidance is based on the current Malaysian legislation on medical devices, which includes the following acts and regulations:
- Medical Device Act 2012 (Act 737),
- Medical Device Regulations 2012,
- Circular Letter of the MDA No.2 / 2014 on Conformity Assessment by way of Verification.
- ISO 13485, Medical Device – Quality Management – Systems – Requirements for regulatory purposes.
According to pacificbridgemedical.com, medical devices in Malaysia are classified into 4 risk classes:
Correct classification of devices is the most important step in the regulatory strategy process, which is especially important in Malaysia due to their rapidly evolving regulatory system. In mid 2016, the Malaysia MDA implemented a formal classification system.