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

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