Singapore

Medical Devices Registration in Singapore HSA

The Health Sciences Authority is the primary medical regulating authority in Singapore (HSA). The Health Items Act, passed by the HSA in 2007, gives them the authority to enforce required product registration and control the supply, distribution, production, importation, and advertising of all healthcare products. The Singapore Medical Device Register (SMDR), which is accessible to the public on the HSA website, contains a list of registered medical devices.

Classification of Medical Devices in Singapore

There are 4 risk-based classes in Singapore for medical devices:

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Medical Devices Registration Process in Singapore

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Medical Devices Registration Services in Singapore

  • Marketing Authorization Holder (MAH) Services

  • Gap Analysis

  • Regulatory Intelligence and Strategy

  • HSA Consultation and Meeting

  • Technical File Preparation and Submission

  • Quality Management System Implementation

  • Audit Support

  • Quality Training

  • Response to HSA Queries

  • Clinical Evaluation and Post Marketing Evaluation