Medical Device Registration in Singapore

Medical device registration in Singapore is regulated by the Health Sciences Authority (HSA) under the Health Products Act. Every medical device must complete medical device registration in Singapore before supply, unless exempt.

Classification

Medical device registration in Singapore requires risk classification:

• Class A – Listing only
• Class B, C, D – Registration required

Registration Routes

Medical device registration in Singapore follows three routes:

• Immediate Route
• Abridged Evaluation Route
• Full Evaluation Route

Route selection depends on device risk, approvals, and documentation.

Timelines & Maintenance

Medical device registration in Singapore includes HSA evaluation timelines based on class. Once approved, devices are listed on the SMDR, and annual retention fees apply to maintain medical device registration in Singapore.

Proper medical device registration in Singapore ensures regulatory compliance and legal market access.