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Australia’s Therapeutic Goods Administration outlines a proposed new regulatory framework for in vitro diagnostic devices in a new consultation paper. Read More
India’s Central Drugs Standard Control Organization is calling on Johnson & Johnson to compensate patients who suffered serious adverse events linked to the company’s ASR hip implants. Read More
The past year has seen a flurry of activity around China’s medical device regulations and much of the reforms have been focused on encouraging innovation while at the same time beefing up post-market enforcement. But for the reforms to be successful, the regulators should consult more with industry, according to attorneys at Ropes & Gray. Read More
The Philippines Food and Drug Administration issued a warning that the Johnson & Johnson First Aid To Go Kit includes devices that have not gone through the registration process and are considered counterfeit and unapproved devices. Read More
Following consultation with stakeholders, India’s Drugs Controller General adopted essential principles for safety and performance of medical devices marketed in India. Read More
In response to price controls imposed by India’s National Pharmaceutical Pricing Authority, Abbott pulled its Xience Alpine drug-eluting stent from the Indian market. Read More
In a reshuffle of regulatory authorities in China, the FDA will split into separate units for medical products and foods, with medical devices handled by the State Drug Administration within the National Market Supervision Administration (NMSA). Read More
India’s Central Drugs Standard Control Organization is requiring laboratories that test medical devices and in vitro diagnostics to register with the agency. Read More
India’s CDSCO issued answers to frequently asked questions on its new medical device rules and said licenses granted after Jan. 1, 2018 will remain valid indefinitely. Read More