Licences, registrations and compliance for importers and manufacturers of medical devices.
Select a service to send an enquiry.
For importers bringing notified medical devices into India. Documentation, application filing, authority query handling and follow-up until approval.
EnquireImport small quantities for testing, trials and evaluation. Documentation, application filing, authority query handling and follow-up until approval.
EnquireState licensing authority route for lower-risk devices. Documentation, application filing, authority query handling and follow-up until approval.
EnquireCDSCO licensing for moderate to high-risk devices. Documentation, application filing, authority query handling and follow-up until approval.
EnquireFor devices that are new to the Indian market. Documentation, application filing, authority query handling and follow-up until approval.
EnquireRegistration number through the CDSCO portal. Documentation, application filing, authority query handling and follow-up until approval.
EnquirePermission to conduct clinical investigations. Documentation, application filing, authority query handling and follow-up until approval.
EnquireCertificates required for export and overseas registration. Documentation, application filing, authority query handling and follow-up until approval.
EnquireQuality management system set-up and audit readiness. Documentation, application filing, authority query handling and follow-up until approval.
EnquireReview of device labels against Indian requirements. Documentation, application filing, authority query handling and follow-up until approval.
EnquireMajor and minor change filings for approved devices. Documentation, application filing, authority query handling and follow-up until approval.
EnquireLicences to sell medical devices wholesale. Documentation, application filing, authority query handling and follow-up until approval.
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