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The International Medical Device Regulators Forum has issued a proposed document explaining how to use quality management systems to regulate software as medical devices. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
A years-long standoff between the U.S. FDA and Maquet ended with a consent decree calling for the devicemaker to improve quality at its three subsidiaries. Read More
The China Food and Drug Administration plans to revise its device good manufacturing practices to include specific GMPs for sterile and implantable devices. The revisions, outlined in a Feb. 9 draft guidance, aim to bring GMPs for these products up to par with international standards, Seth Goldenberg, director of global regulatory strategy at NAMSA, tells GMP. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
China’s medical device authority released a draft regulation outlining how it will accredit medical institutions that conduct clinical trials for devices. Read More
Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says. Read More
Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More
San Antonio, Texas, contract manufacturer Voss Plastics received a 10-citation warning letter for serious lapses in good manufacturing practices and lack of written procedures for adverse event reporting. Read More