As part of Singapore’s ongoing efforts to guarantee the safety of medical devices that enter its markets, the country’s health regulatory authority has released draft guidance on labeling requirements for key categories of devices. The guidance builds on labeling regulations already in force.
The guidance covers in-vitro medical devices, implantable medical devices, devices that incorporate or administer medicinal or biological substances, and those that emit radiation. It mandates that labeling on all such devices includes detailed information on how to use the device safely, what materials it is composed of, how it is to be used and calibrated, and how specimens associated with it are analyzed for quality, safety, and accuracy, among other elements.
In addition, implantable devices must display an identification code readable even after implementation. Labels on radiation-emitting devices must include clarification for users including the type and intensity of radiation emitted by the device and safety practices for protecting the patient from unintended radiation. Also, labels on devices that incorporate or administer medicinal or biological substances must include specific identification and safety indications of the substance used too.
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/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-23-r2-guidance-on-labelling-for-medical-devices(2022-sep)-pub.pdf