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India’s Central Drug Standards Control Organization has issued a draft guideline on good manufacturing practices for medical devices and diagnostics — the latest in an effort to increase the quality of medtech products, which are governed loosely under the country’s drug laws. Read More
An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warn. Read More
The FDA has warned Miami-based Trucare Biomedix-USA over slips on supplier audits, purchasing controls and other good manufacturing practices. Read More
Inadequate CAPA procedures led all other causes for Form 483s issued to devicemakers in fiscal 2014, while purchasing control issues jumped from sixth place to third in the FDA’s annual ranking of inspection observations. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More