Singapore Emergency Use Pathways for Medical Devices and IVDs

Singapore Health Sciences Authority (HSA) regulates medical devices and IVDs under the Health Products (Medical Devices) Regulations 2010. All devices, except Class A devices, require registration before importing or selling in Singapore.

The HSA has standard Special Access routes for importing unapproved devices in various situations, such as compassionate use and alleviation of stock shortages. In addition, special provisions for devices specifically to address the COVID-19 outbreak have been published.

Regulations, guidance, and resources

The special access route is based on and described further in the following guidance:

Device types and eligibility Criteria

In response to the COVID-19 outbreak, the HSA has issued special provisions for COVID-19 IVD test kits, and Hand Sanitisers, Masks, Thermometers and Protective Gear.

Through the standard special access routes, unapproved devices may be imported when they meet the criteria outlined in Guidance on Special Authorisation Routes (SAR). These criteria include alleviation of stock shortages, which may be applicable to some devices in the current COVID-19 situation.

Capital equipment (e.g., X-ray machines, CT scanners, MRI machines) is excluded from the special access routes. Product registration is required for such devices.

Pathway overview

The standard special access route is described in Guidance on Special Authorisation Routes (SAR).

The special provisions to address COVID-19 have different routes depending on the product:

Hand Sanitizers

Hand sanitizers do not require approval from the HSA for import and sale. 

Masks, Thermometers and Protective Gear for Medical Professionals

An importer’s license is waived for importers of these products; a simple notification to the HSA of the brand and quantity imported is required. Distribution records must be maintained.

COVID-19 Diagnostic Tests

For Covid-19 IVDs, the following process should be followed:

  1. Compiled basic device information (description, intended use, summary of validation, etc.)
  2. Email information and request to HSA.
  3. HSA performs expedited review and responds within 3 days.
  4. If acceptable, HSA issues provisional authorization.
  5. Begin importing.
  6. Provide periodic safety/performance reports to HSA.
Ventilators

The HSA is temporarily allowing the use of anaesthesia machines and positive airway pressure devices as emergency ventilators. In order to do so, clear instructions must be provided on repurposing the product as a ventilator.

Additionally, the HSA has relaxed change notification requirements for approved ventilators so that modifications and upgrades can be made. Changes can be implemented without HSA approval if they do not affect the registered performance specs and comply with the Essential Principles.

Lastly, the HSA has invited companies to discuss importation of unregistered ventilators directly. A contact form is available on the HSA website.

Navigating special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. If your device or IVD is critical to the COVID-19 response, special access or emergency use routes may be available. Contact us if you have questions about your product's eligibility or expedited regulatory pathways in countries affected by COVID-19. 

Updated 18 June 2020.

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