Simplifying Global Compliance
A series of joint assessments of EU device notified bodies found a “generally satisfactory” level of compliance with legal requirements and best practices, but revealed multiple issues with organizational requirements and quality management systems, according to an interim report by the Notified Bodies of Government. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More
Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More
The U.S. Food and Drug Administration has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
The U.S. Food and Drug Administration’s medical device center may prequalify scientifically validated tools to support the development and regulatory evaluation of new devices. Read More
Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency, saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
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