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Market Standing & Non-Conviction Guidance

This document provides guidance for obtaining a market standing or non-conviction certificate from the Central Drugs Standard Control Organization for notified medical devices in India. It outlines the purpose, scope, submission process, and requirements for the application, which includes a covering letter, valid manufacturing or import license, import details for the last 3 years if applicable, a legal undertaking that no adverse actions have been taken against the company, and a list of products requiring the certificate. The certificate will be valid for 1 year or until the license expires, whichever is earlier.

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DINESH GUMMADI
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79 views2 pages

Market Standing & Non-Conviction Guidance

This document provides guidance for obtaining a market standing or non-conviction certificate from the Central Drugs Standard Control Organization for notified medical devices in India. It outlines the purpose, scope, submission process, and requirements for the application, which includes a covering letter, valid manufacturing or import license, import details for the last 3 years if applicable, a legal undertaking that no adverse actions have been taken against the company, and a list of products requiring the certificate. The certificate will be valid for 1 year or until the license expires, whichever is earlier.

Uploaded by

DINESH GUMMADI
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd

GUIDANCE DOCUMENT FOR OBTAINING MARKET STANDING OR NON-CONVICTION

CERTIFICATE OF NOTIFIED MEDICAL DEVICES

Guidance Document
(Medical Device and Diagnostics Division)

Title: GUIDANCE DOCUMENT FOR


OBTAINING MARKET STANDING/NON-
CONVICTION CERTIFICATE OF NOTIFIED
MEDICAL DEVICES
Doc No.: CDSCO/MD/GD/MSC/NC/01/00
Date : 01.05.2019

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION


DIRECTORATE GENERAL OF HEALTH SERVICES
MINISTRY OF HEALTH & FAMILY WELFARE
GOVERNMENT OF INDIA

Page 1 of 2
GUIDANCE DOCUMENT FOR OBTAINING MARKET STANDING OR NON-CONVICTION
CERTIFICATE OF NOTIFIED MEDICAL DEVICES
1. PURPOSE: To provide guidance to Indian manufacturers or importers for
submission of application to CDSCO for obtaining Market Standing or Non-
Conviction Certificate of Notified Medical Devices.

2. SCOPE: This guidance document is applicable to those medical device


manufacturers or importers in India who are having valid manufacturing license
or import license and intend to obtain Market Standing or Non-Conviction
Certificate of Class C & D Notified Medical for tender purpose.

3. MODE OF SUBMISSION: Offline (Hard Copy)

4. GUIDANCE:

An application shall be made to the Central Licensing Authority by the


manufacturer, having a valid License to manufacture for sale or for distribution of
notified Medical Device

4.1 Covering Letter – The covering letter should clearly specify the intent of
the application. The list of documents that are being submitted (Index with
page no’s) as well as any other important and relevant information may be
provided in the covering letter. The covering letter should be duly signed
and stamped by the authorized signatory, indicating the name &
designation of the authorized signatory along with the name and address
of the firm.

4.2 A valid copy of license to manufacture for Sale or for Distribution or


Import License of Medical Devices along with approved product list
issued by Central licensing Authority.

4.3 Bills of Entry and Import Details (in case of import) of last 3 years for
applied products.

4.4 Legal Undertaking on 100 Rupees registered notarized stamp from the
manufacturer or importer stating that no action has been initiated against
them or been convicted due to adverse events, market complaint and Not
of Standard Quality (NSQ) report of any product in India.

4.5 List of products for which the Market Standing or Non-Conviction


Certificate is required (in compact Disc also).

Note: Validity of the Market Standing or Non-Conviction Certificate will be 1


year from the date of issuance or till validity of license, whichever is earlier.

Page 2 of 2

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