Latest Headlines
Indonesia Market Summary and Registered Devices ReviewOctober 23, 2020 - 7:15 pm- Thai FDA Ramps Up Documentation Requirements for General Medical DevicesOctober 9, 2020 - 4:40 pm
- Update: 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
Indonesia Market Summary and Registered Devices Review
/in Indonesia, Latest News /by Ilham HidayattulahIn recent years, the government has made healthcare a priority for the 261 million Indonesians, providing a lot of potential for medical device manufacturers of all technology levels. The government has also taken numerous steps to curb corruption through their online e-catalogue and other methods which has helped bring in more foreign companies and investment.
Thai FDA Ramps Up Documentation Requirements for General Medical Devices
/in Latest News, Thailand /by Binh ThaiWith 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.
Vietnam Launches Medical Device Pricing Portal
/in Latest News, Vietnam /by Bryan GilburgOn September 9th, the Vietnamese Ministry of Health (MoH) officially opened the Information Portal of Medical Equipment Pricing. Under the new system, the list price of medical equipment will be published (by configuration) on this Ministry of Health hosted website.
Update: 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.