Placement and supply of a medical device in the Malaysian market requires the device comply with the requirement of the Medical Device Act 2012, (Act 737), including that the device be registered with the Medical Device Authority (MDA). The Medical Device (Exemption) Order 2016 however has provided for some medical devices to be exempted from registration requirement if they fulfilled the criteria for special access and submit a notification to the Authority. These special-access devices, are, instead, required to notify MDA during each importation.
In line with that, MDA has issued a guidance document on how to apply for an Acknowledgment on Notification letter from the Authority, for these special-access devices. MDA defines special access medical device as medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.
There are 2 routes available to make the Acknowledgment for Notification application with MDA, Route A and Route B. A special-access medical device is eligible for Route A if it is of utmost crucial use in an emergency situation that poses an immediate risk to a patient’s life or long-term health where the required medical devices are not available in Malaysia. Route B is for situations where the special-access medical device is not needed immediately, such as for compassionate use basis, alleviation of stock-out situation or design and/or operation that is likely to support or enhance the safety outcomes of the procedure or treatment for the patient.
Active medical devices that require installation and/or designated medical devices shall not be eligible for notification of exemption for special access. Examples are X-ray machines, CT scanners, and MRI machines. An applicant who wishes to import and/or supply of a medical device through special access route shall notify the Authority by following the steps and as per summarized in Annex A of this guidance document. Each notification is charged a fee of RM300, after which the Authority will review the information and make an assessment of the documentation provided, if the device adheres to the definition of “medical device”, eligible for exemption and the documents and information submitted are complete.
The notification to MDA does not exempt the applicant from abiding to any other law or regulations in Malaysia, such as refer ring to the Royal Malaysian Customs department for more information about the importation procedures; and referring to Atomic Energy Licensing Board (AELB) for more information about application for irradiating apparatus demonstration/exhibition procedure. MDA also stresses that there shall be an identification for a special access medical device, and a statement that it shall be only used by a medical practitioner for patient under his care.
For more information on how to correctly notify MDA for the importation of special-access medical devices, kindly refer to Guidance Document MDA/GD/0043, when the official copy is released soon.
Guidance Document: Notification of Unregistered Medical Device for Special Access