A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China

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Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.

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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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Philippines FDA Alters Requirements for Radiation Licensing During COVID-19

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FDA’s Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.

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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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Philippines FDA Announces New Requirement for All Medical Devices

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On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.

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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’s CDSCO Extends List of Notified Devices

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On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.

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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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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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