Although Singaporean medical practitioners were allowed to import unregistered medical devices for use on their patients with approval from the HSA, there have not been specific guidelines on this issue until this August. According to this recently issued guideline from the Health Science Authority (HSA), in order to obtain this approval, the representative of the medical institution needs to justify that there are special clinical needs that require the use of an unregistered medical device.
The HSA listed examples of clinical justifications, which include compassionate use, minimization of the disrupted supply of a similar registered device, the established history of use of the unregistered device, etc. Even though the HSA will not evaluate the safety and performance of the unregistered device, the dealer and medical practitioner are responsible for making sure that the device complies with other Singaporean regulations such as the Radiation Protection Act.
Please note that this route is only applicable for special circumstances. If a manufacturer intends to supply their medical device product on a long-term basis, they need to register their device with the Singapore HSA.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.hsa.gov.sg/medical-devices/registration/special-access-routes/qualified-practitioner-request