KENNA RASIKLAL

“Medical device manufacturers have asked if hand sanitizer is considered a medical device during COVID-19, but they are not and therefore do not need HSA approval.”

Kenna Rasiklal, Asia Actual Singapore Principal Consultant

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Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear

Published on: January 22nd, 2021

Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore. Since January 31st, 2020, the following medical devices do not need an importer’s license from the HSA:

  • Surgical masks
  • Particulate respirators
  • Thermometers
  • Protective gear such as isolation gowns and gloves

If importing for commercial use, a notification must be submitted to the HSA (form: https://go.gov.sg/HSAExemptionOrderNotification). If importing for personal use, you do not need to submit a notification to the HSA, but quantities will be limited to the following:

  • Surgical masks: 3 boxes (3 x 50 pieces) per person
  • Particulate Respirators: 3 boxes (3 x 20 pieces) per person
  • Thermometers: 2 units per person

Note: if the quantities are above these limits, then a notification will be required to be submitted to the HSA

The official announcement from the HSA can be found here.

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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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