IVD Kits

Services for ivd kits

Select a service to send an enquiry.

Import licence for notified IVD kits. Documentation, application filing, authority query handling and follow-up until approval.

Test licences to import or manufacture IVDs. Documentation, application filing, authority query handling and follow-up until approval.

Licensing for IVD manufacturers across all risk classes. Documentation, application filing, authority query handling and follow-up until approval.

Registration number for IVDs outside the notified list. Documentation, application filing, authority query handling and follow-up until approval.

Permission to evaluate IVD performance in India. Documentation, application filing, authority query handling and follow-up until approval.

Certificate for export and overseas registrations. Documentation, application filing, authority query handling and follow-up until approval.

IVD label review against Indian rules. Documentation, application filing, authority query handling and follow-up until approval.

QMS implementation and certification assistance. Documentation, application filing, authority query handling and follow-up until approval.