COVID-19 Diagnostic Test kits
To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.
Information required includes:
A brief description of your test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)
Intended purpose of your test
Information for Users (IFU) for the test
Summary of analytical validation (e.g. Limit of Detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data collected for your test where available
Summary of any planned or ongoing validation including clinical studies
HSA will get in touch with the applicant within 3 working days.
Types of masks and respirators
Stay protected from respiratory particles with the correct usage of masks and respirators.
Masks and respirators can be bought from reliable sources like pharmacies and clinics, or their respective online stores. Avoid dubious or unknown websites or sellers, as the quality of their surgical masks and respirators is not assured.
Specifications of quality surgical masks and N95 respirators
Surgical mask
In contrast to a thin, single-layered or double-layered paper mask, a surgical mask usually consists of two or more layers of flat or pleated fabric.
Ideally, a surgical mask:
Has the manufacturer’s name printed on its packaging.
Has a filtration efficiency of 80% or higher.
Carries an expiry date on its packaging.
Does not contain materials that you are allergic to.
Provides a good fit.
N95 respirator
When purchasing a respirator, check that it is labeled with the NIOSH certificate number and is not expired.
If it is NIOSH-certified, it should:
Have a filtration efficiency of 95%.
Provide a good fit to your face.
Carry instructions on how to wear and discard the respirator.
The respirator should not contain materials that can cause allergic reactions.
You may also check if the product is listed on NIOSH’s website as a NIOSH-certified N95 respirator.
Guidance on the Import of Hand Sanitizers, Masks, Thermometers and Protective Gears
If these devices are imported for commercial use, the importer will have to submit a notification to HSA. However, if imported for personal use in quantities within the limits indicated below, notification to the HSA will not be needed. The quantities are as follow:
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
Guidance for Decontamination of Single Use Respirators
Although respirators are generally intended to be single-use devices, due to COVID-19 situation, there have been critical shortages of respirators globally.
Consequently, practical methods to decontaminate used respirators effectively are being developed. Normally, medical devices used for decontamination are classified under Class C and would require review and approval by HSA before being supplied in Singapore. However, due to the current situation, HSA will approve these medical devices intended for decontaminating used respirators via the provisional authorization pathway.
HSA has published a guidance covering the key regulatory requirements for Provisional Authorization for decontamination devices for respirators. This publication also includes certain good practices for healthcare institution and other user facilities to take note of when deploying and using these devices.
Medical devices that have received authorization for decontamination of respirators are also listed in the HSA website.
3D Printed Medical Devices
To address the increased demand for critical medical products in response to the Covid-19 pandemic, some organisations are considering the use of 3D printing to manufacture these essential devices (e.g. nasopharyngeal swabs, personal protective equipment, et cetera).
The Health Sciences Authority (HSA) has provided guidance on 3D printing of essential medical devices and accessories for use in Covid-19 situation in the website,
'Guidance on 3-D Printing of Essential Medical Devices and Accessories for Use in COVID-19 '
On 25 January 2021, Singapore has published the following for Public Consultation
'Regulatory Guideline for 3D-Printed Medical Devices'
Source: Singapore HSA
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