Non Conviction Certificate

In India, approved medical devices are regulated like pharmaceuticals under the 1940 Drugs and Cosmetics Act and its 1945 Rules. For approved medical devices in India, the Central Drugs Standards Control Organization (CDSCO) sped up the application procedure for awarding market standing certifications and non conviction certificates.

This action is being done to help importers or makers of medical devices in India file their requests for Non-Conviction Certificates of Notified Medical Devices. This applies to Indian makers and importers of medical devices who have an active license for manufacturing or importing and who want to get a Non-Conviction Certificate of Notified Medical Devices.

Why Is The Non Conviction Certificate Required?

The non conviction certificate mainly certifies that a firm or a manufacturer who is held a valid drug manufacturing license for a certain period has not been convicted under Drug & Cosmetic Act, 1940.

What Is The Validity Of The Non Conviction Certificate?

Depending on when the license expires, the Market Standing Certificate will be valid for one year from the date of issuance.

How Does The Non Conviction Certificate Look Like?

It is certified that M/s ———————————- situated at —————————— ————— are holding valid drug manufacturing license No.——————- valid till _______________ The firm has not been convicted under Drug & Cosmetic Act, 1940 and rules there under in _______ State.

State Drug Controller,

Certifying & Licensing Authority

Directorate General Health Services

Also Read – Market Standing Certificate

What Is The Procedure Of Obtaining The Non Conviction Certificate?

The State Drug Controller of the Central Licensing Authority of the Directorate General of Health Services must receive an application from manufacturers who have active licences to make medical devices for sale or distribution.

What All Documents Are Needed In Order To Obtain A Non Conviction Certificate?

  • The purpose of the application should be made crystal clear in the covering letter. Any other significant or pertinent information, including the list of papers being presented (indexed with page numbers), may be included in the covering letter. The authorized signatory must properly sign and stamp the covering letter, confirming their name and title as well as the name and address of the company.
  • List of goods that call for a non-conviction certificate (in compact Disc also).
  • The manufacturer or importer must sign a legal declaration on a 100 Rupee registered, notarized stamp stating that no legal action has been taken against them or that they have not been found guilty as a result of unfavorable events, market complaints, or Not of Standard Quality (NSQ) reports of any products in India.
  • List of goods that call for a non-conviction certificate (in compact Disc also).
  • A legitimate copy of the Central Licensing Authority’s license authorizing the manufacture of medical devices for sale, distribution, or import, as well as the license’s approved product list.

What Do You Need To Get Non Conviction Certificate?

To get non conviction certificate in India you have to follow the process and submit the necessary documents such as:-

  • Cover Letter
  • Affidavit from Magistrate (not below Grade I) on Rs. 50 Stamp paper
  • GMP Certificate
  • Approved Product List
  • Others
  • Application Fee : Rs 250
  • Service Charge (Grama one| B1| K1) :Rs 100
  • ServiceTime (Days) : 30 Days

What Is The Eligibility To Get Non Conviction Certificate?

To get the non conviction certificate the agency should have a Valid ASU Number.

Who Will Issue The Non Conviction Certificate?

The state drug controller of the certifying & Licensing Authority of the directorate general health services who has issued the license shall issue the non conviction certificate.

How ELT Corporate will help you to Get Non Conviction Certificate?

The ELT corporate will help you understand the term non conviction certificate and explain to you when you require it. You can simply get in touch with the team and they will help you and resolve your queries. If you need non conviction certificate then we will help you to get it as soon as possible.