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
Regulatory News
Global medical device regulatory updates and registration guides
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
How Medical Device Exports to the EU Can Fail Because of the Carton
Part 2: IFUs, the Chain of Responsibility and a Self-Check List Part 1 covered the six most frequent gaps in
Shanghai’s Third-Party Medical Device Warehouses: An Analysis of 58 Licensed Companies
As of 22 August 2026, the Shanghai medical products administration’s public database lists 58 companies whose medical device business licenses
TGA Follows the EU MDR Extension: Australia’s New Transition Timeline for Medical Devices
In the medical device industry, almost every extension of the EU MDR (Medical Device Regulation) transition period affects product lines
Global Regulatory Convergence Accelerates: An In-Depth Look at the IMDRF Regulatory Reliance Playbook
If your company is expanding into several overseas markets at once – say the EU, ASEAN and Latin America –
Condom Registration in Thailand: A Medical Device Category with Its Own Legislation
In most countries’ medical device classification systems, condoms are just one of many low-risk products. In Thailand, however, their status