Tag Archive for: medical devices

Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

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On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.

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China to Require All Electromedical Devices Meet Updated Standards

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This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

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China to Implement New Electrical Safety Standards for Medical Devices

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An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.

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China to Accept Foreign Generated Test Reports

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This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

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China’s Green Pathway Registration for Innovative Medical Devices

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China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

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Indonesia Market Summary and Registered Devices Review

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In 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.

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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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CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

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As 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.

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