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    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...
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    Asia Regulatory Roundup: AHWP to Harmonize Device Submissions in Asia (10 November 2015)

    AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...
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    Major Changes Set for Taiwan’s Medical Device Registration Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory changes will take effect starting 1 July 2015.  First, TFDA will introduce a two-step review program for marketing authorization appli...