What are the import regulations for medical devices?
The Import of Medical Devices regulations depends on the country or region. Generally, they involve compliance with stringent standards ensuring safety, efficacy, and quality control. These regulations typand post-market surveillance.
What are the key challenges faced by medical device companies in navigating the regulatory landscape in India?”
Medical device regulation in India encounters several challenges navigating the regulatory landscape. These include complex registration processes, evolving quality standards, and the need for local clinical data.
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