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- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
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South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning
/in South Korea/by Sarah BaikThe South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.
India Seeks Input on Medical Device Classification
/in India, Latest Updates/by Gunjan VermaAll formerly unregulated medical devices are now being transitioned to require registration in India under the Medical Device Rules, 2017. These products should be Registered prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023 depending on the product’s risk classification.
India Seeks Input on IVD Equipment Classification
/in India, Latest Updates/by Gunjan VermaAll IVD related equipment, instruments and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.
CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST
/in China, Latest Updates/by Bryan GilburgAs part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.
THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET
/in Latest Updates, Thailand/by Binh ThaiImporting 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.
CHINA: REGULATORY AND COMMERCIAL UPDATES
/in China, Latest Updates/by Bryan GilburgThe NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China
LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND
/in Latest Updates, Thailand/by Binh ThaiThe 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.
VietNam: High Growth Fast Market Access
/in Latest Updates, Vietnam/by David VoVietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.