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- 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
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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Vietnamese MOH Establishes New Medical Device Advisory Council
/in Latest Updates, Vietnam/by David VoOn November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to help with the regulatory transition.
China Regulatory and Commercial Updates
/in China, Latest Updates/by Bryan GilburgThe NMPA has continued to stay busy this year, releasing numerous guidance documents and updates to their regulatory requirements. Here are some of the most important updates from the last few months.
Indonesia Market Summary and Registered Devices Review
/in Indonesia, Latest Updates/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 Updates, 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 Updates, Vietnam/by David VoOn 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 Updates/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 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.