Corona (COVID-19) diagnostic test kit registration
Use of Corona (COVID-19) virus diagnostic test kits (IVDs) requires registration with the Ministry of Health. It is forbidden to import and sell without a license.
Corona virus diagnostic test s are divided into several groups and varying accuracy:
– Immunological / Serology IgG/ IgM based
– Molecular diagnostics
– Open and Closed kits (dedicated/ machine specific)
– Research only IVDs
The Ministry of Health has recently imposed the requirement for Special Clinical Trial Validation of Serologic, IgG/ IgM based, Fast result Corona tests / kits.
Sponsors must perfom and provide a validation clinical trial to validate the kit.
It is a mandatory requirement in order to obtain a license.
Mind Pharma Europe will process your quality test kits to become available quickly. Best technology and products should be registered smoothly, without delay. Public safety is an embedded priority for us.
We, at Mind Pharma Europe consult, assess the documentation and certifications required (CE, ISO, licenses etc). Our team provides guidance and consultation on such registrations.
We assemble the Corona test application dossier “full kit dossier”, process submissions and escort till license.
Once license is issued, we support the launch of product and can handle import licenses and permits.
Our support extends beyond registration!
Need more information? Need to process submission? Contact us here.
Mind Pharma, managed by Shavit Fragman provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.