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The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Read More
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Read More
The EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Read More
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Read More
Regulatory agencies in Asia have rolled out multiple emergency measures for medical devices and diagnostics to help respond to the COVID-19 outbreak. Read More
The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Read More
Device contract manufacturer Minnesota MedTec was found to be lax in training its production staff and handling customer complaints, according to a Form 483 received following an inspection of the firm’s Maple Grove, Minnesota facility. Read More