🇸🇬Singapore Medical Device Regulations

Guidance on Medical Device Product Registration

Revision 11 guidance document for medical device product registration. Covers application procedures, documentation requirements, and evaluation pathways.

Medical Device Guidance Documents

Collection of guidance documents for medical device regulation including registration, classification, labeling, and post-market requirements.

Medical Device Registration Overview

Overview of medical device registration in Singapore. Class A devices are exempt; Class B, C, and D require registration before import, supply, or manufacture.

Medical Device Registration Information

Portal for medical device registration including new product registration, variations, and renewal. Covers submission requirements and processing timelines.

Health Sciences Authority - Medical Devices Overview

HSA regulates medical devices in Singapore under the Health Products Act. The Medical Device Branch oversees product registration, licensing, and post-market surveillance.

Medical Device Dealer License

Dealer licensing requirements for importers, wholesalers, and manufacturers of medical devices in Singapore. License required before conducting business activities.