Medical device registration in Singapore

The main medical regulatory body in Singapore is the Health Sciences Authority (HSA). Since 2007, the HSA has established the mandatory registration of the medical device, regulating the supply, distribution, production, import and advertising of all health products. Registered medical devices are listed on the Singapore Medical Device Register (SMDR)
Device classification in Singapore is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest-risk products
Maytal experts, together with their partners located in I Singapore, can:
  • prepare HSA medical device submission dossier
  • manage the relationships with HSA, during the review process
  • Supply local representation service, necessary for foreign manufacturers.