With the current focus being set on increased testing efforts and the enormous global demand for approved COVID-19 Test Kits to be used clinically (as well as for home usage purposes in some countries), let us shed some lights today on what it takes to bring a test kit through the approval process in Singapore.
Knowing the different types of test kits
- Antigen Rapid Tests (ARTs)
- Do-It-Yourself (DIY) / home-use tests
- Polymerase Chain Reaction based Molecular tests (PCR)
- Antibody (Serology) Tests, and others
Are you a supplier, manufacturer, importer, or distributor looking to place your COVID-19 test kits in the Singapore Market?
Understanding the current situation in Singapore
The Singapore government has highlighted the need for faster and cheaper tests to enable routine testing in the workplace, social, or community settings. DIY COVID-19 tests can even be purchased over-the-counter at pharmacies in the near future.
In response to the pandemic, HSA fast-tracked the approval of COVID-19 Tests in Singapore via Provisional Authorisation. In the last year, Stendard has supported multiple companies in their application for provisional authorisation of the COVID-19 tests in Singapore and in Europe.
The challenge right now
However, the situation has changed!
- From 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 tests.
- Furthermore, by 31 December 2021, any provisional authorisation that has been approved will expire.
Even if your test kits had been granted provisional authorisation, you will need to submit them for the full product registration process, to continue being supplied in Singapore in 2022.
So if you wish to start or continue supplying your COVID-19 tests on the Singapore market, your products will either need to be approved by HSA via full product registration route or unless you are authorised under the Pandemic Special Access Route (PSAR)*.
*Note: To be eligible to apply for PSAR, you need to be directed by the Singapore Ministry of Health (MOH) to supply your product as an “emergency medical device”.
COVID-19 Test Kit classification
For full registration, your COVID-19 tests are likely to be the highest risk class: Class D. This involves more extensive regulatory and documentation requirements to be submitted to HSA.
The 5 steps that Stendard can help you with
Since the start of the pandemic, Stendard has helped numerous clients through the most difficult hurdles of product registration. Based on these past experiences, these are the 5 steps that we intend to support your COVID-19 Test kits’ approval in Singapore:
STEP 1: PRODUCT CLASSIFICATION
STEP 2: GUIDANCE ON PRODUCT REGISTRATION REQUIREMENTS
STEP 3: PREPARATION OF TECHNICAL DOSSIERS
STEP 4: REGULATORY SUPPORT THROUGH THE REGISTRATION PROCESS
STEP 5: PRODUCT LICENSE HOLDING
In addition, our expertise and support network also allows the expansion of your Test Kits to other markets, such as Europe, the US, Australia, and other ASEAN countries.
What about importing and distributing COVID-19 test kits?
Besides product registration, if you want to import and/or distribute COVID-19 test kits (or other medical devices) in Singapore, we can also help you in:
- Applying for Importer and/or Wholesaler (distributor) licenses from Health Sciences Authority
- Setting up your Quality Management System (QMS) for GDPMDS SS620:2016 (Good Distribution Practice for Medical Devices) or ISO 13485:2016
- Supporting your certification of your QMS
- Guidance on regulatory requirements for Importers and Distributors of medical devices in Singapore