Import and supply of unregistered medical devices at the request of a licensed healthcare facility

PHMCA/HCSA licensed laboratories and medical facilities who import and supply unregistered devices for use on their patients will require approval from us.

Conditions for using this special access route (SAR)

In an emergency or when all available medical therapies fail, licensed healthcare facilities may request for dealers to import unregistered medical devices for their patients. Approval from us is needed for such scenarios.

The Head of Department or equivalent representing the licensed healthcare facility needs to provide clinical justification that the unregistered medical devices are required to meet special clinical needs arising in the course of his practice, which includes the following:

This includes:

  • Absence of alternative treatment option; or
  • Available alternative treatments failed or deemed ineffective or unsuitable for the patient according to the doctor’s or the dentist’s clinical judgement; and
  • Patient’s health will be clinically compromised without the requested treatment

The unregistered medical device is needed to minimise disruption to the continued supply of a similar registered medical device.

  • Absence of registered alternatives or lack of a specific feature in registered medical device; or
  • Available registered medical devices or models are deemed ineffective or unsuitable for the patient according to the doctor’s or the dentist’s clinical judgement; or
  • User’s (doctor or dentist) familiarity or expertise in terms of device technology, design and/or operation that is likely to support or enhance the safety outcomes of the procedure or treatment for the patient; and
  • Patient’s health will be clinically compromised without the requested medical device

The unregistered medical device was used:

  • before 1 January 2012
  • in a licensed private hospital as approved by the relevant authority of that healthcare institution
  • in a licensed medical clinic as required by the doctor or dentist

There are no known safety issues related to the use of the device.

The dealer and qualified practitioner need to ensure that the unregistered medical device complies with other regulatory requirements such as the Radiation Protection Act governed by the National Environment Agency.

Capital equipment (e.g. X-ray machines, CT scanners, MRI machines) would not qualify for this SAR. Product registration is required for such devices.

Note: The safety and performance of the device is not assessed by us during application review.

You should register your medical device if you intend to supply it on a long-term basis (and quantity).

Eligibility

You must hold a certified quality management system with a Good Distribution Practice for Medical Devices (GDPMDS) certification.

Documents required

You need to submit the following documents for our review: 

  1. SAR Device List (Downloadable from MEDICS)
  2. Request form1934 KB for unregistered medical device for use on patients by qualified practitioner and licensed healthcare facility
  3. MOH Clinical Justification Review Form For Unregistered Class D Medical Device30 KB1
  4. Instructions for Use, Product Insert, or Operations Manual by the product owner
  5. Primary medical device label
  6. A copy of the licence under the Private Hospitals and Medical Clinics Act (PHMCA) or Healthcare Services Act (HCSA) with the Licence Number clearly legible
  7. A copy of quality management system certificate (e.g. Good Distribution Practice for Medical Devices (GDPMDS) if a valid Importer licence with GDPMDS is unavailable
  8. Declaration on Distribution Records

 

1 Applicable only to requests from Public Healthcare Institutions (PHIs), for these specific categories of Class D medical devices - (i) new technologies and state-of-the-art medical devices for clinical use on patients, including novel indications for existing medical devices or technologies; and (ii) unregistered implants

Fees and turn-around-time

Refer to medical device fees and turn-around-time for more information.

How to apply

Submit your application through MEDICS. Ensure you have the following before you access the e-service:

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).