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.
Regulatory News
Global medical device regulatory updates and registration guides
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
Malaysia’s Medical Device (Designated Medical Device) Order 2026 Takes Effect on 1 June: Laser, HIFU and Liposuction Equipment Now Regulated by the MDA
On 1 June 2026, Malaysia’s Medical Device (Designated Medical Device) Order 2026 (official reference P.U.(A) 10) came into force. Made
Philippine FDA Launches the eSumbong Complaint System: What Medical Device Companies Need to Know
On 6 May 2026, the Philippine Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0594, formally launching the new
Malaysia–Thailand Regulatory Reliance Fully Implemented
On 1 May 2026, Malaysia’s MDA (Medical Device Authority) and the Thai FDA (Thai Food and Drug Administration) jointly announced
Thailand’s New Medical Device Labeling Rules from 20 June: e-IFU, SaMD-Specific Requirements and the Two-Year Transition Explained
From 20 June 2026, new rules on medical device labeling and instructions issued by Thailand’s Ministry of Public Health (MOPH)