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

India Extends Deadline for Class C and D Import Licenses

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On May 16th, 2024 India’s CDSCO extended allowances for the importation of Class C and D Medical Devices currently under review.

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Indonesia Invests in Quality Healthcare Access

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On May 6th, 2024 the President of Indonesia, Joko Widodo launched the new hospital-based Specialist Doctor Education Program which supports Indonesia’s growing commitment to the healthcare industry and provides strong support for investment in Indonesia. 

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Indonesia Implements GDPMD Requirement

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On April 30th, 2024, the Ministry of Health in Indonesia announced that it will be implementing a Good Distribution Practice of Medical Devices (GDPMD) requirement.

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Indonesia Boosts Medical Device Sales Prospects

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Recent developments have made the Indonesian market an even more attractive place to generate medical device sales growth.

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Asia Actual Summit in Indonesia

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April 23rd to 27th, 2024, Asia Actual Indonesia hosts Asia Actual USA, Singapore, China, Vietnam, Philippines, and Thailand, for a Summit.

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Medical Device Risk Classification Problems in Vietnam

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According to a report published on May 7th, 2024, contractors have been apprehended misrepresenting IVD and Medical Device risk classification to participate in bidding parties.

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Philippines Issues Guidance on Medical Device Labeling

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On April 5th, the CDRRHR provided guidance for CMDR medical device labeling in the Philippines related to previously CMDN labeled stock.

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Innovative Medical Device Registration in Japan

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In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.

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Medical Device Consultation in Japan

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Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).

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Australia’s SaMD Regulatory Deadline

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Beginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.

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