FDA QMSR Eight Months In: Why an ISO 13485 Certificate Is Not Enough
The QMSR builds on ISO 13485, but FDA-specific requirements still apply — plus an MDSAP roadmap and a self-check list.
Regulatory News
Global medical device regulatory updates and registration guides
Indonesia’s KMK 951/2026 Takes Effect: Imported AI Software Needs Local Clinical Validation
Indonesia’s new software and AI medical device guidelines apply immediately, with local clinical validation for imported AI.
UK Confirms Indefinite Recognition of CE-Marked Medical Devices: Good News, but 5 UK Obligations Remain
The UK will indefinitely recognise EU MDR / IVDR CE-marked devices — but UK local obligations remain.
45 Days to Go: EUDAMED Registration of Existing Devices Closes on 28 November – Is Your Product Registered?
EVERBIZ | EU MDR/IVDR Regulatory Update On 28 May 2026, the first four modules of the European database on medical
China Issues New Medical Device GMP Inspection Guidelines: 200 Items in Three Risk Levels from 1 November
The new medical device GMP inspection guidelines take effect on 1 November, with 200 inspection items graded at three levels. Here are the key points.
[Sharing] A Medical Device Warehouse in Cleveland, USA, Open for Shared Use
A medical device warehouse in Cleveland is open for shared use, with a lead-shielded room and initial importer services available.
5 Days to Go: Indonesia Halal Certification Mandatory for Class A Medical Devices from 18 October – Get the Three Dates Right
From 18 October, Class A devices containing animal components must hold a halal certificate.
New HSA Rule in Singapore: Incomplete Registration Applications Will Be Rejected from 2027
The HSA has introduced a premarket submission checklist, fully enforced from 1 January 2027. EVERBIZ summarizes the key points and what to do.
How to Complete a CPNP Notification Before Placing Cosmetics on the EU Market
To enter the EU market, cosmetics must be notified in the CPNP before they are placed on the market. In
Thailand Cracks Down on Non-Compliant Medical Devices: Registering Colored and Contact Lenses in Thailand
In August this year, police raided a warehouse in Bang Phli, Bangkok, after a tip-off that many online shops were