Asia/Pacific

ARTICLES

India to Enforce New Code for Marketing Devices

As India gets ready to enforce its new medical device regulations in January, the government is gearing up to release a new uniform code for medical device marketing practices. Read More

NPPA to Revisit Price Controls on Coronary Stents in Early 2018

India’s National Pharmaceutical Pricing Authority said it will revisit the ceiling prices imposed earlier this year on coronary stents. Read More

India Aims to Ease Import Process for Medical Devices

Medical device and IVD imports to India should not be held up at ports because of “slight confusions” over product names, pending applications during mergers and acquisitions, or shelf-life issues if the importers have valid registration certificates and import licenses, according to the Central Drugs Standard Control Organization. Read More

TGA Updates Regulatory Framework for 3D-Printed, Personalized Medical Devices

Australia’s Therapeutic Goods Administration is proposing five changes to its regulatory approach for 3D-printed and… Read More

Devicemakers Support TGA’s Approach to Beefing Up Sanctions And Penalties

Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance. Read More

AdvaMed Petitions for Relief From India’s Device Price Caps

AdvaMed filed a petition with the U.S. Trade Representative seeking relief from India’s new price controls on certain medical devices. Read More

China to Allow Use of Overseas Trial Data in Device Applications

In a significant policy shift, China plans to accept data from foreign clinical trials in its medical device approval process if the device is already approved overseas. Read More

China’s New Device Catalog Makes Significant Classification Changes

Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More

China Looks West for Boost to Medical Device Industry

Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials. Read More

Australia Issues Update on Medical Device Reform

Australia’s Therapeutic Goods Administration released a status report on regulatory reforms for medical devices, including upcoming changes. Read More