Special Access Routes for Covid-19 Related Products - ASEAN Countries
Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period for the traders.
1. Import of Hand Sanitisers, Masks, Thermometers and Protective Gear
Health Sciences Authority (HSA) does not require an importer’s licence for certain products (masks, thermometers and personal protective equipment) to meet the surge in demand during this Covid-19 period.
2. Expedited Approval of Covid-19 Diagnostic Tests in Singapore via Provisional Authorisation
A provisional authorisation process for tests intended for detection and/or diagnosis of Covid-19 infection has been set up to ensure timely availability of good quality performing test kits.
3. Regulatory Flexibility for Ventilatory Support Devices
An alternative pathway has been put in place to allow regulatory flexibility towards ventilatory support devices due to an anticipated increase in demand of respiratory devices for Covid-19 patients. This regulatory flexibility will remain in effect during the Covid-19 pandemic period and will be revised based on the local situation.
4. Provisional Authorisation for Decontamination of Single Use Respirators
To meet the demand of respirators during the Covid-19 pandemic period, provisional authorisation pathway for decontamination of respirators has been set up.
1. Special Access Route A Notification replaced by Route B for Exempted Medical Devices
Medical Device Authority (MDA) will no longer consider Special Access notification of exempted medical devices for Covid-19 through Route A.
1. Expedited Registration for Covid-19 related products
Thai Food and Drug Administration (FDA) has put in place measures to facilitate the import of certain products during this Covid-19 period.
1. Special Access Scheme for Covid-19 related products
Indonesia has issued a temporary removal of import license requirements for medical equipment and protective gear to facilitate its availability.
During this period of need, ASEAN Authorities are working for ways to ensure that Covid-19 related product are available and expedite the process.
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