Clarification(ICB/EPSA6/RDF-Routine/MD/10/22)
January 4, 2023
Tender Code: ICB/EPSA6/RDF-Routine/MD/10/22
Tender Type: ICB
Closed Date: 01/16/2023 2:00pm
Opening Date: 01/16/2023 2:30pm
Product category: Medical Instruments
Download File: Download
To: All participants of tender with Ref. No. ICB/EPSA6/RDF-Routine/MD/10/22
Subject: Clarification on tender with ref. No. ICB/EPSA6/RDF-Routine/MD/10/22
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 Specific Certificate from EFDA (for Quoted Model) & Valid Product specific Certificate from SRA Region (WHO Certificate for Refrigerators);
- Second Priority: Valid Product specific Certificate from SRA Region (WHO Certificate for Refrigerators);
- For Laundry Machine: – Valid Product Specific Certificate of Directive 426/2016/or Full Product Quality Assurance from SRA Region.
The Valid Product Specific Certificate from SRA Region 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, Directive 426/2016. | Please Refer link:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main |
6 | Medicine and Healthcare Products Regulatory Agency, UK | |
7 | Health Canada, Canada | |
8 | Ministry of Food and Drug Safety, South Korea |
We hope the above points clarify your request.
With Best Regards
CC:
- Deputy Director General (Inbound Logistics)
- Medical Equipment Tender Management Team
- Archive
EPSA