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

Invoicing Requirements for Medical Device Software in India

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India is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.

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Thailand Implements New Medical Device Regulations

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On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.

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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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Navigating the New Vietnamese Public Medical Device Pricing Portal

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The new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.

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Australia’s TGA Continues Alignment with EU Regulations

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the TGA made significant changes concerning software, spinal implants, personalized devices, drug administering products, and companion diagnostics that affect many medical device manufacturers. Additionally, the Active Implantable Devices (AIMD) classification will be absorbed into Class III as of November 25, 2021.

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India Temporarily Suspends Customs Duties for Covid-19 Related Medical Devices

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On Saturday, the Indian Ministry of Finance released a Notification (No. 28/2021–Customs) exempting the following medical devices from customs duties effective immediately until July 31st. The Notification comes as the Indian government continues to take additional steps to battle the ongoing COVID-19 emergency. 

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Sales Target Spotlight: Philippines’ St. Luke’s Medical Center

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St. Luke’s Medical Center (SLMC) in both Quezon City and Taiguig/Global City are top-tier hospitals with Joint Commission International (JCI) accreditation that operate at the quality of international standards. The use of novel technologies for procedures such as 2D and 3D breast ultrasound, laser dermatology procedures, robotic assisted urological surgeries, etc. make SLMC a great target for innovative medical device manufacturers.

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Sales Target Spotlight: China’s Boao Hope City

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The Chinese national government has established a special economic zone on Hainan Island with a focus on medical devices and wellness. Medical device manufacturers seeking sales growth in China should be aware of the Boao Hope City development particularly those with new and innovative devices.

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New Advertising Exemption in Thailand

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A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.

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Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories

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The Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories.

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