Max House,
Tower- C, 7th Floor, Bahapur, Okhla Industrial, Estate, Phase-
3, Opposite Okhla Railway Station, New Delhi-110020, India
Contact
Person
1
. Mr. Sandeep Dua 2
. Charlene Holm
Designation
Head Technical
& compliance IMETA Regional Technical &
Compliance Director
Tel
+91 11 2692
9000 (eight
lines) +91 11 2692 9000
Fax
+91 11 2692
9001
Email
ID
sandeep.dua@bsigroup.com
Charlene.Holm@bsigroup.co
m
Website
Valid
From
30 March 2026
Valid
Upto
11 August
2027
Accreditation Standard
ISO/IEC
17021-1:2015 and IAF MD 9
Scopes of
accreditation
ISO/IEC
17021-1:2015 and ISO/IEC 17021-3:2017
Main Technical Areas (as per IAF MD 8:2023)
Description (Main Technical Areas)
Technical Areas
A1.1
Non-Active Medical Devices
Non-implantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.3
Active Implantable medical devices
General active implantable medical devices
Implantable medical devices other than specified above
A1.4
In Vitro Diagnostic Medical Devices (IVD)
In Vitro Diagnostic Medical Devices (IVD)
Reagents and reagent products, calibrators and control materials for:
Clinical Chemistry
Immunochemistry (Immunology)
Haematology / Haemostasis / Immunohematology
Microbiology
Infectious Immunology
Histology/Cytology
Genetic Testing
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
