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 […]
Regulatory News
Global medical device regulatory updates and registration guides
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
Entering Southeast Asian Markets: How to Choose an ISO 13485 Certificate
In recent years, more and more Chinese medical device companies have made Southeast Asia a key region for overseas expansion.
Countdown to Indonesia’s New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare
From 18 October 2026, the scope of mandatory halal certification in Indonesia will expand further to cover cosmetics, chemical products,
Hyaluronic Acid Fillers Going to Southeast Asia: Regulatory Focus Points and Document Checklist
Hyaluronic acid (sodium hyaluronate) fillers are generally placed in the highest risk class in the main Southeast Asian markets (Class
How Can Hong Kong and Macao Medical Devices Take the “Green Lane” into the Greater Bay Area? A Complete Guide to the GBA Connect Application Process
For Hong Kong and Macao medical devices that want to enter the Guangdong-Hong Kong-Macao Greater Bay Area market but have
Where to Start with “Smart Crib” Compliance
– From an ordinary baby product to a vital-signs monitoring device: one extra function can mean a completely different compliance
Vietnam’s New Medical Device Labeling Rules Take Effect on 1 July 2026: Five Mandatory Items, Supplementary Labels and Font-Size Requirements Explained
The Vietnamese government has issued Decree No. 37/2026/ND-CP (detailing the Law on Product and Goods Quality), fully replacing Decrees 43/2017/ND-CP