In light of the recent Covid-19 outbreak, MDA has allowed for the importation and placement of certain high-demand medical devices under the special access route. Ventilators are among this special category of medical devices, to ensure their availability in healthcare facilities and minimise a disruption of treatments during the COVID-19 emergency situation.
Subsequent to the receipt of notification from the applicant, an Acknowledgement on Notification will be issued by the MDA for the purpose of importation and placement of the special access medical device, after assessment of the specification by an MDA Expert Advisory Committee.
Hence, as a follow up to this situation, MDA has issued a special guidance document which specifies requirements for the importation and placing in the market of ventilators during an emergency situation through special access notification.
Through the Expert Advisory Committee and based on the requirements of this Guidance Document, a recommendation on the suitability of the medical device to be granted special access will be provided. The end-users/healthcare institutions/government departments will make their decision based on the recommendation or otherwise, depending on their need and be responsible on the use of the MD during the emergency period.
The main point to take note of here is that ventilators that are eligible for special access must be able to fulfil either one of the following criteria:
- Ventilators approved/registered by recognised countries (US, EU, Japan, Australia, Canada)
- Ventilators approved/registered with foreign regulatory authorities or through emergency situation requirements.
- Ventilators manufactured locally.
Each criterion has its own set of requirements to be fulfilled in order to be eligible, which can be consulted in the Guidance Document. MDA has also specified the preferred technical requirements for ventilators hoping to be imported into the country using this special access route.
Apart from that, in order to meet the huge demand for ventilators in clinical setting due to this emergency, MDA also agrees for manufacturers to make certain modifications to approved indications, claims, or functionality of anaesthesia machines to function as make-shift ventilators, without prior submission of a premarket approval, as long as the modification will not create an undue risk. Before that, manufacturers must take clear note of specific requirements drawn by the Authorities for use of anaesthesia units as emergency ventilators. In such circumstances, MDA recommends that the manufacturer provide clear instructions delineating approved indications and claims from those that are not, in addition to a general statement about changes that have not been subject for pre-market approval.
However, noting that this move is not encouraged unless absolutely necessary, MDA also recommends several alternative uses of respiratory devices used to address shortages.