Practical guides and expert commentary on medical device regulation across global markets — written for founders, engineers, and regulatory teams.
April 17, 2026·regMD Team
EU AI Act + MDR Dual Compliance — The August 2027 Deadline for AI Medical Devices
Article 113(c) of the EU AI Act sets the high-risk obligations deadline for MDR/IVDR-regulated AI medical devices at August 2, 2027 — not August 2, 2026 (which applies to Annex III standalone high-risk AI). Dual conformity, dual QMS documentation, AI-specific post-market monitoring — what medical device manufacturers need in place, and what the pending Digital Omnibus proposal may change.
EU AI ActEU MDRIVDR
Read more
April 17, 2026·regMD Team
FDA Reclassifies Non-Invasive Bone Growth Stimulators from Class III to Class II (May 2026)
FDA's April 2026 Final Order moves non-invasive bone growth stimulators (LOF / LPQ) from PMA to 510(k) pathway. Effective May 18, 2026. What manufacturers need to know.
HSA released Revision 8 of its Guidance on Licensing of MIW in April 2026. Updated QMS declaration annexes, export / re-export declarations, and compliance pathways across Class A–D devices. What SG licence holders need to check.
HSASingaporelicensing
Read more
April 17, 2026·regMD Team
HSA SaMD & AI Device Landscape — What's In Force in Singapore Right Now (April 2026)
Four Singapore regulatory updates between December 2025 and March 2026 have reshaped how SaMD and AI-enabled medical devices are regulated. GL-04 R4 lifecycle rules, GN-37 CMP pilot, AIHGle 2.0, GN-15 R13 CDSS scope clarification, and the AI-SaMD Exemption Order — all live. What SG medtech teams need to know.
HSASingaporeSaMD
Read more
April 17, 2026·regMD Team
TGA Compliance Principles 2026–2027 — SaMD Is Now an Explicit Enforcement Priority
Australia's TGA named Software as a Medical Device (SaMD) as an enforcement priority in its 2026–2027 Compliance Principles. Combined with the February 2026 AI/software guidance update, the message to device manufacturers is clear: lifecycle documentation is no longer optional. What ARTG holders and applicants need to do.
TGAAustraliaSaMD
Read more
April 15, 2026·regMD Team
Private Medtech and the HSA AI-SaMD Sandbox: It Isn't for You — Here's the Path That Is
HSA's proposed AI-SaMD sandbox (Feb 2026) is for selected public healthcare entities, not private medtech founders. If you're building a Class A or B AI medical software product as a startup or vendor, here's what your actual HSA path looks like — and where ISO 13485 fits in.
SingaporeHSAAI-SaMD
Read more
April 15, 2026·regMD Team
Singapore HSA's AI-SaMD Sandbox: What the Exemption Order Actually Says
The proposal became subsidiary legislation — Health Products (AI Standalone Mobile Application — Exemption) Order 2026 (S 66/2026), in force 13 February 2026. Exemption-based sandbox for AI-SaMDs developed by selected public healthcare entities. Here's what the source actually says — scope, obligations, and what it doesn't specify — for the public-healthcare teams it's aimed at.
SingaporeHSAAI-SaMD
Read more
April 15, 2026·regMD Team
After WHO ML4: How to Treat Your HSA Submission as an Export Credential, Not Just a Market Entry
Singapore's HSA reaching WHO Maturity Level 4 changes the strategic value of an HSA dossier. Here's a practical read on what's actually established, what's still aspirational, and what it means for how you write your next Singapore submission.
SingaporeHSAWHO
Read more
March 21, 2026·regMD Team
FDA 510(k) vs PMA: Which Pathway Does Your Medical Device Need?
Understand the difference between FDA 510(k) clearance and PMA approval. Learn how device classification determines your regulatory pathway, timeline, and cost for the US market.
FDA510kPMA
Read more
March 21, 2026·regMD Team
Medical Device Classification: How 15 Markets Compare (2025)
Compare medical device classification systems across the US, EU, Singapore, Japan, China, and 10 more markets. Understand why the same device can be classified differently worldwide.
classificationcomparisonglobal
Read more
March 21, 2026·regMD Team
How to Classify Your Medical Device Under EU MDR (2025 Guide)
A practical guide to classifying medical devices under EU MDR 2017/745. Learn the 22 classification rules, risk classes, and how to determine your device's regulatory pathway in Europe.
EU MDRclassificationCE marking
Read more
March 21, 2026·regMD Team
Medical Device Registration in Singapore: HSA Classification & Pathway Guide
Complete guide to registering medical devices with Singapore's HSA. Covers risk classification (A–D), SMDR registration, evaluation routes, timelines, and costs for 2025.
SingaporeHSAclassification
Read more
March 21, 2026·regMD Team
SaMD Classification: How to Classify Software as a Medical Device in 2025
Guide to classifying Software as a Medical Device (SaMD) across FDA, EU MDR, and global markets. Learn why software classification is the most complex — and most misunderstood — area in medtech regulation.
SaMDsoftwaredigital health
Read more
March 21, 2026·regMD Team
Singapore Becomes First Country to Reach WHO's Highest Rating for Medical Device Regulation
On March 10, 2026, Singapore's HSA became the first regulatory authority in the world to achieve WHO Maturity Level 4 for medical devices. Here's what it means for medtech companies planning market entry.