To: All participants of tender with Ref. No. ICB/EPSA6/MoH-SDG/Neuro/MD/20/22
Subject: Clarification on tender with ref. No. ICB/EPSA6/MoH-SDG/Neuro/MD20//22
Dear Sirs,
Reference is made to the above captioned tender. We hereby clarify that the evaluation will be done as per the priority given below:-
First Priority: Valid Product Certificate from EFDA & Valid Product Certificate from SRA Region;
In case of no bidder with 100% line item under 1st priority:
Bidders with more line item under 1st priority (EFDA & SRA) registered from the lot item will be given priority than bidders with less item registered (SRA & EFDA). Bidders without Valid Product Certificate from SRA Region will be rejected
Second Priority: Valid Product Certificate from SRA Region;
The Valid Product Certificate from SRA Regions are:
S.No.
Stringent Regulatory Authority (SRA)
Remark
1
US Food and Drug Administration, USA
2
Ministry of Health, Labor and Welfare, Japan
3
Therapeutic Goods Administration (TGA), Australia
4
Health Science Authority, Singapore
5
Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017, 90/385/EEC Active Implantable medical devices.
