Question 1

What is HSA and why is it important for medical device companies?

Accepted Answer

HSA (Health Sciences Authority) is Singapore's national regulatory authority for health products, including medical devices, IVDs, pharmaceuticals, and biologics. HSA regulates medical devices under the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. All medical device companies must obtain HSA registration and maintain compliance to sell products in Singapore's advanced medical device market.

Question 2

What is the SHARE platform and how does it affect device registration?

Accepted Answer

SHARE (Singapore Health Product Access and Regulatory E-System) is HSA's new digital platform that replaces the legacy MEDICS system. Fully operational since July 14, 2025, SHARE streamlines medical device product registration and license submissions with improved user experience, real-time tracking, and integrated workflows. All manufacturers must transition to SHARE for device submissions.

Question 3

How are medical devices classified in Singapore?

Accepted Answer

Singapore uses a four-tier risk-based classification system: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Classification is based on intended use, invasiveness, duration of contact, and whether the device delivers energy or medicinal products. HSA's GN-15 guidance (updated August 2025) provides detailed classification rules aligned with international standards (FDA, EU MDR).

Question 4

What is a Singapore Registrant and do foreign manufacturers need one?

Accepted Answer

A Singapore Registrant is a Singapore-based legal entity required for foreign medical device manufacturers. The Registrant must be registered with HSA, have local staff, and acts on behalf of the manufacturer in all regulatory interactions including device registration, post-market surveillance, and compliance activities. All foreign companies must appoint a Singapore Registrant to register and sell medical devices in Singapore.

Question 5

What are the abridged evaluation routes?

Accepted Answer

HSA offers abridged evaluation routes for devices with prior authorization from recognized regulatory authorities: FDA (USA), EMA/CE Mark (Europe), Health Canada, TGA (Australia), or PMDA (Japan). These routes allow faster approval by leveraging reviews from reference agencies, reducing evaluation time from 180 days to as little as 60-90 days for qualifying devices.

Question 6

How can I stay updated on HSA regulatory changes?

Accepted Answer

This page automatically aggregates HSA and Singapore medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, Asia Actual, and others. Pure Global provides comprehensive regulatory support for Singapore market access.

Question 7

What sources does this HSA news page aggregate from?

Accepted Answer

We aggregate Singapore and HSA news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Pacific Bridge Medical, Emergo by UL, Asia Actual, Citeline MedTech Insight, Pure Global's proprietary Singapore research team, and Qualtechs. All sources are filtered to show only Singapore-related regulatory updates using advanced keyword matching including HSA, SHARE, Health Products Act, and Singapore-specific terminology.

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