Emerging Markets Regulatory Tracker: Australia, China (Vol. 4 No. 28)
This article was originally published in PharmAsia News
Australia’s TGA has announced a one-year extension to submit reclassification applications for partial total hip, knee and shoulder joint implants. In China, the FDA issued notices on a voluntary recall of medical devices from GE Medical Systems and Smith & Nephew.
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India’s health ministry has laid out basic steps towards an overhaul of drug regulation at the local level, identifying a number of areas of concern.
China has released the results of back on proposed standards for the accreditation of clinical trial committees, investigators and sites.
China has finalized revised rules for the classification of medical devices, which will come into effect from the start of next year.