Easing the path to market for medical devices used in emergencies, Malaysia’s Medical Device Authority (MDA) in April exempted certain devices from registration requirements.
The changes, included in a first edition guidance document, “Notification on Medical Devices for Special Access” apply to devices that alleviate immediate risks to the life or long-term health of patients. They also apply to medical devices not available in Malaysia and approved for use in any Global Harmonization Task Force (GHTF) country.
Devices may also be exempted from the registration requirements if they are out of stock in country. The exemptions do not apply to x-ray machines, CT scanners and MRI machines that require installation.
Manufacturers granted the exemptions will be charged an appropriate fee by the MDA.