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DEC L A R A T I O Nofcon F OR M ITY: (Note: According To First Schedule On Rules of Classification of Medical Device)

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47 views

DEC L A R A T I O Nofcon F OR M ITY: (Note: According To First Schedule On Rules of Classification of Medical Device)

Uploaded by

ppc
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Date: 11/11/2024

DECLARATION OF CONFORMITY

I, Mitul Suthar of Griportho Sugicals Private Limited (GSPL), hereby declare that the below
mentioned medical device-

(i) complies with all the requirements under the Act;


(ii) has been classified according to the classification rules as specified in First Schedule
on Rules of Classification of Medical Device; and
(iii) conforms to requirements specified in APPENDIX 1 of Third Schedule on Essential
Principles for Safety and Performance of Medical Devices under Medical Devices
Regulations 2012.

(A) Particulars of medical device


Generic name : Pins & Wires and Instrument Set
Specified name : Pins & Wires and Instrument Set
Brand/model : Griportho
Country of origin : India
Manufacturer : Griportho Surgicals Private Limited (GSPL)
Manufacturing site : R.S No. 99/2, P-2, Village & Post: Karmasiya kheda,
Rasulabad –Vitoj Road, Tal: Waghodia, Dis: Vadodara, Gujarat, India -391510
Risk-based classification : Class C
Classification rule : Rule 8
(Note: according to First Schedule on Rules of Classification of Medical Device)
GMDN code : 32854, 66933

Medical device registration number or any approval code:


Certificate number : 180309QS/NB
Issuance date : 11/09/2018
Expiry date : 10/09/2023

(B) Quality Management System certificate (“QMS”)


Conformity Assessment Body issuing the certificate:
Certificate number : MD-QMS/91/R/I/2395/e, MD-QMS/91/R/N/2395/b
Issuance date : 11/05/2023
Expiry date : 19/05/2026

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(C) Standard Applied

No. Standard Ref. No. Title Description


1. ISO 13485:2016 Medical devices — Quality management systems —
Requirements for regulatory purposes
2. EN ISO 14630:2012 Non-active Surgical Implants – General Requirement

3. EN ISO 14602:2011 Non-active surgical implants. Implants for osteosynthesis.


Particular requirements
4. EN ISO 14971:2019/A11:2021 Medical Devices - Application of Risk Management for
Medical Devices
5. EN ISO 10993-1:2020 Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing
6. EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity
(ISO 10993-3:2014)
7. EN ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests
for in vitro cytotoxicity
8. EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for
local effects after implantation
9. EN ISO 10993-10:2021 Biological evaluation of medical devices -- Part 10: Tests
for irritation and skin sensitization
10. EN ISO 10993-11:2018 Biological evaluation of medical devices -- Part 11: Tests
for systemic toxicity
11. EN ISO 15223-1:2021 Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied -
Part 1: General requirements (ISO 15223-1:2016,
Corrected version 2017-03)
12. EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and
routine control of a sterilization process for medical
devices
13. EN ISO Sterilization of health care products - Microbiological
11737-1:2018/A1:2021 methods - Part 1: Determination of a population of
microorganisms on products (ISO 11737-1:2018)
14. EN ISO 20417:2021 Information to be Supplied by the manufacturers of
medical devices.
15. ISO 5832-1:2016 Implants for Surgery- Metallic Materials Part 1: Wrought
Stainless steel.
16. ISO 5832-3:2021 Implants for surgery - Metallic materials - Part 3: Wrought
titanium 6-aluminium 4-vanadium alloy
17. ISO 5835:1991 Implants for surgery -- Metal bone screws with
hexagonal drive connection, spherical under-surface of

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head, asymmetrical thread
-- Dimensions
18. ISO 5838-2:1991 Implants for surgery — Skeletal pins and wires, Part 2:
Steinmann skeletal pins — Dimensions
19. ISO 5838-3:1993 Implants for surgery — Skeletal pins and wires, Part 3:
Kirschner skeletal wires
20. ISO 10334:1994 Implants for surgery — Malleable wires for use as sutures
and other surgical applications
21. EN ISO 6892-1:2019 Metallic materials — Tensile testing — Part 1: Method of
test at room temperature
22. ISO 7800:2012 Metallic materials — Wire — Simple torsion test

23. ISO 7801:1984 Metallic materials — Wire — Reverse bend test

24. ASTM E1086 –22, Method for emission spectrometric analysis of austenitic
and ferritic stainless steels point to plane technique (First
Revision).
25. ASTM E18:2022 Standard Test Methods for Rockwell Hardness of Metallic
Materials
26. IS: 10146 Specification for Polyethylene and its copolymer for safe
use in contact with foodstuff, Pharmaceuticals & Drinking
Water
27. IS 9879-98 Method for emission spectrometric analysis of austenitic
and ferritic stainless steels point to plane technique
28. ISO/TR 20416:2020 Medical devices — Post-Market Surveillance for
manufacturers
29. MEDDEV 2.7.1 Rev 4 Clinical Evaluation: A Guide For Manufacturers And
Notified Bodies Under Directives 93/42/EEC and
90/385/EEC
30. MEDDEV 2.12-1:2013 (Rev8) Guidelines on a Medical Devices Vigilance System

31. MEDDEV 2.4/1 revision 8 Guidelines for the Classification of Medical Devices

32. MEDDEV 2.12/2 revision 2 Guidelines on Post Market Clinical Follow-Up Studies: A
Guide for Manufacturer And Notified Body
33. MDCG 2020-7 Post-market clinical follow-up (PMCF) plan template a
guide for manufacturers and notified bodies
34. MDCG 2020-8 Post-market clinical follow-up (PMCF) evaluation report
template. A guide for manufacturers and notified bodies
35. NB-MED/2.12/Rec1 Post-marketing surveillance (PMS) post
market/production
36. ISO/TR 24971:2020 Medical devices — guidance on the application of ISO
14971

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37. ISO/TR 20416:2020 Medical Devices - Post-Market Surveillance for
Manufacturers

I am fully responsible with all the information provided in this declaration. This declaration of
conformity is valid from 11/11/2024.

I fully understand and acknowledge that it is an offence under Section 76 of the Medical Device
Act 2012 [Act 737] to make, sign or furnish any declaration, certificate or other document
which is untrue, inaccurate or misleading.

Authorised Signature Official Stamp :

______________________
Name: Mr. Mitul Suthar
Designation: Plant Manager/ MR
Date: 11/11/2024
Note: MDA Guidelines for Declaration of Conformity (DOC)

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