In January, Singapore’s MOH updated GN-26 and GN-27 SAR for non-registered medical devices. Doctors, medical institutions, and labs can now more easily import non-registered Class D devices that are new or have new indications, or are new implants. Certain categories of non-registered Class D devices can now be reviewed in about 4 weeks and then imported for limited use. To do this, public hospitals will need to send the clinical advantages to Singapore’s MOH for approval. Since these products have not been approved by the HSA, there will be some risk to patients and doctors. However, if the need outweighs the risk, the MOH will allow such non-registered imports.
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