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.
