Thailand Implements New Medical Device Regulations

On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.

New Advertising Exemption in Thailand

A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.

LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.

THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

Thai FDA Ramps Up Documentation Requirements for General Medical Devices

With the announcement of The Regulations and Conditions Of Maintaining Technical Documents For Safety And Effectiveness Of The Medical Device, the Thai FDA has begun requiring the local medical device License Holder to provide upon request technical documents for any registered device. As the registration process for most General Medical Devices (all but 10 device types fit into this category) does not involve technical documents, this new requirement will impact most medical devices.

THAI FDA PLANS TO CHARGE FEES FOR EXPERT REVIEW IN MEDICAL DEVICE REGISTRATIONS PROCESS

Thailand to Implement New Medical Device Classification System

The Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.