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

Indonesia invests more in Healthcare via a Hospital-based education system

Indonesia Invests in Quality Healthcare Access

On May 6th, 2024 the President of Indonesia, Joko Widodo launched the new hospital-based Specialist Doctor Education Program which supports Indonesia's growing commitment to the healthcare industry and provides strong support for investment in Indonesia. 
Indonesia increases healthcare investment via 6 pillar transformation health policy

Indonesia Boosts Medical Device Sales Prospects

Recent developments have made the Indonesian market an even more attractive place to generate medical device sales growth.
GPDMD in Indonesia

Indonesia Implements GDPMD Requirement

On April 30th, 2024, the Ministry of Health in Indonesia announced that it will be implementing a Good Distribution Practice of Medical Devices (GDPMD) requirement.