Latest Headlines
India To Require Local Certification of All Power CordsSeptember 24, 2020 - 5:21 pm- South Korea Releases Guidance for Software using Big Data, AI, and Machine LearningSeptember 18, 2020 - 5:40 pm
- India Seeks Input on Medical Device ClassificationSeptember 15, 2020 - 5:21 pm
- India Seeks Input on IVD Equipment ClassificationSeptember 15, 2020 - 3:44 pm
- CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LISTSeptember 1, 2020 - 4:32 pm
- THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKETAugust 17, 2020 - 9:52 pm
- CHINA: REGULATORY AND COMMERCIAL UPDATESAugust 17, 2020 - 5:38 pm
- LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILANDAugust 10, 2020 - 9:52 pm
- ARTIFICIAL INTELLIGENCE (AI) SOFTWARE REGISTRATION IN SINGAPOREJuly 23, 2020 - 5:58 pm
- VOLUNTARY MEDICAL DEVICE REGISTRATION IN HONG KONGJuly 10, 2020 - 11:17 pm
India To Require Local Certification of All Power Cords
/in India, Latest News /by Gunjan VermaWith effect from December 1, 2020, India power cords, cord sets, plugs and sockets must carry the Mark of Conformity (product approval mark) which has been established by the Central Government of India through the Bureau of Indian Standards (BIS) Act (2016), BIS Rules 2018, and BIS Conformity Assessment Regulations (2018).
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 News /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 News /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 News /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 News, 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 News /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 News, 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.