Recently, the COVID-19 outbreak caused a massive shortage on crucial personal protective equipment and ventilators in the country. To manage the situation, MDA allowed manufacturers to bring in these devices using the Route A allocated in Notification of Special Access, which is a special route to alleviate out-of-stock situations for crucial medical devices in the country. As situation improved and with lesser COVID-19 cases being reported daily, MDA has now ended the eligibility for these crucial medical devices to be marketed using Route A of Notification of Special Access. Hence, starting from 13th May 2020, MDA will not be entertaining Notification of Special Access (Route A) applications. However, this does not take away manufacturers’ right to make an application for Notification of Special Access, altogether. They are now required to go through Route B only and all particulars requested in the form shall be provided. Route B is specially for medical devices on compassionate use basis, fulfilling the following requirements:
• Absence of alternative treatment option; or
• Available alternative treatments failed or deemed ineffective or unsuitable for the patient according to the medical practitioner’s clinical judgement; and
• Patient’s health will be clinically compromised without the requested treatment.
Follow this, the rationale of the notification must meet the criteria for Route B as specified under Section D of the Notification form. Failing to meet the criteria will result in an unapproved notification.