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Regulatory Updates Regulatory Requirements for Medical Device Sterilization
Three obligations are taken on by a manufacturer that supplies a sterile device in India. The process has to be...
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Regulatory UpdatesUS FDA Compliance FDA PMA eSTAR Draft Guidance: What
On September 18, 2026, FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)...
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US FDA Compliance FDA CDRH Annual Reporting Requirements for
Manufacturers often assume that making a laser product means an annual FDA filing. That assumption is wrong. The obligation depends...
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Regulations Food Packaging and Labelling Requirements in
On September 4, 2026, the UK Food and Standards Agency released packaging and labelling guidance. It provides the legal requirements...
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CDSCO ComplianceRegulations CDSCO Post-Approval Change Applications for Medical
A CDSCO medical device licence is not a finish line. Manufacturing sites move, designs get refined, labels get...
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Regulations Veterinary Pharmaceuticals Regulations and Registration in
Japan has a well-defined framework for veterinary medicines. For global regulatory teams and animal health companies, however, meeting...
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Regulations Managing Label Changes Under IVDR for
Since IVDR came into effect, IVD manufacturers have had to respond to changes across clinical evidence, quality management,...
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Cosmetics InsightsRegulations Cosmetics Regulations & Registration Process in
Anyone planning to put cosmetics on the EU market must notify the products in accordance with Regulation (EC)...
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