Tag Archive for: device classification

Thai FDA Ramps Up Documentation Requirements for General Medical Devices

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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.

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LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

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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.

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CHINA: REGULATORY AND COMMERCIAL UPDATES

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The 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

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THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

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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.

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India Seeks Input on IVD Equipment Classification

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All 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.

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India Seeks Input on Medical Device Classification

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All 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.

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South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning

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The 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.

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Vietnam Launches Medical Device Pricing Portal

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On 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.

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Submission Changes in China: ToCs and the eRPS

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Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

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Singapore Releases New Guidance of Medical Device Software

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Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.

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