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 […]
Regulatory News
Global medical device regulatory updates and registration guides
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
The Updated EU Classification Guidance Explained: What Manufacturers Should Look at and Do
On 20 April 2026, the EU Medical Device Coordination Group (MDCG) updated its classification guidance, officially MDCG 2021-24 Rev.1. This
A Must for ASEAN Market Entry: The Medical Device CSDT Submission Template Explained
Many medical device companies preparing to enter the six ASEAN markets (Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines) first
Singapore Medical Device Regulations Updated Again: Key HSA Changes in 2026 and How Companies Should Respond
Overview | In 2026, Singapore’s Health Sciences Authority (HSA) continued to update its guidance on medical device product registration, change
Vietnam Joins the Hague Apostille Convention on 11 September, Opening a Window to Faster Cross-Border Medical Device Registration
On 11 September 2026, the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (the “Hague Apostille Convention”) enters
Major Update to the FDA Recognized Consensus Standards Database
On 19 February 2026, the US Food and Drug Administration (FDA) published in the Federal Register the latest revision of