China – Chinese regulators delay medical device UDI implementation

China’s National Medical Products Administration (NMPA) has extended the trial period for its medical device unique device identification (UDI) program in response to the...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA explains how it will handle lapsed conformity assessments due to MDR...

Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – New compliance dashboard for post-market medical device reviews

From 19 October 2020, the process by which the Therapeutic Good Administration (TGA) engages with sponsors will change. A new Post Market Review Compliance Dashboard...

China – China asks for global distribution of its COVID-19 vaccines

China is in talks to have its locally-produced COVID-19 vaccines assessed by the World Health Organization, as a step toward making them available for...

India – Researchers in India develop paper-strip COVID-19 test

India's drug authority last month approved a paper-strip test for COVID-19 that shows results in less than an hour, the head of the government...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea’s MFDS publishes draft regulatory revision and new guidance documents

South Korea’s Ministry of Food and Drug Safety (MFDS) solicited public feedback on a draft revision to its medical device regulatory system that would,...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan PMD Act revisions include fast-track reviews for some medical devices and...

Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations of new and updated...

Australia – Australia to permit some self-test IVDs after industry calls for change

The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India’s CDSCO proposes extensive risk classification lists for medical devices and IVDs

Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products...
Hong Kong regulator will continue to recognize South Korean approvals

China – Medical device usability testing in China: Key considerations for manufacturers

New guidance on medical device usability testing from China’s National Medical Products Administration (NMPA), anticipated to be issued in late 2020, will entail compliance...

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