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

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

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.

Grow with Us

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.

Blog Posts

Australia SaMD Transition Deadline

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia's Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Read more
Thai FDA Documentation Exemptions for Concise and Full Regulatory Pathways

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Read more
Hong Kong MDD adds Singapore HSA to Reference Country List

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
Read more