KENNA RASIKLAL

“These SAR changes refer to GN-26 and GN-27 applications and take effect on the 1st of April, 2022.”

Kenna Rasiklal
Principal Consultant
Asia Actual Singapore

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Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)

Published on: March 30th, 2022

Singapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022. Class C and D devices being used by public health institutions (PHIs) will now need to complete an additional clinical justification form. Changed are being implemented to continue improving patient safety in Singapore. The new Special Authorization Routes (SAR) guidance can be found here and hospitals have already been made aware of the new requirements.

While the HSA has not released official review times, it was noted during the zoom meeting that class C and D GN-26 and GN-27 applications will take longer than class B (14 working days). For urgent applications, the HSA is advising license holders to split their GN applications according to the risk class to expedite their review.

What to Do with Stock Covered by an Expired GN-27

The HSA has also clarified that if a GN-27 has expired, the supply and USE of the devices is no longer allowed and a new application will need to be submitted for the remaining stock.

Special Authorization Routes Available in Singapore

GN-26 applications are for “licensed qualified practitioners to seek approval for the import and supply of unregistered medical devices for use on his patient” while GN-27 applications are for “healthcare facilities licensed under the Private Hospitals and Medical Clinics Act (PHMCA) / Healthcare Services Act (HCSA) to seek approval for the import and supply of unregistered medical devices for use on their patients.”

Current fees can be found here and more information on the regulatory process can be found here.

Special Authorization Routes (SAR) Fees and Turnaround Time

Below are the current HSA fees for SARs but it is expected that new fees and timelines will be issued for the new class C and D routes in the near future.

Special Access Routes Fees

(SGD)

Turnaround time (in working days)
Import for re-export of unregistered devices $258 14
Unregistered devices for non-clinical purposes $258 14
Unregistered devices requested by qualified practitioners $155 14
Unregistered devices requested by a licensed PHMC $360 14

All fees are in Singapore dollars. S$100 = US$70.5 as of January 2022

Please see our Singapore Medical Device Registration page for more information on registration fees and timelines.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in Singapore. Contact Asia Actual today if you have questions or need support importing medical products into Singapore.

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