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      To demonstrate the business of pharmaceuticals and medical device obtaining Market Standing Certificate is necessary. The certificate is issued by the CDSCO (Central Drugs Standard Control Organisation). To understand more about the CDSCO Market Standing read out for its implication and process.

      Why Is The Market Standing Certificate Required?

      In India, the Drugs and Cosmetics Act of 1940 and its Rules from 1945 govern recognised medical devices as drugs. The Central Drugs Standards Control Organization (CDSCO) expedited the application process for issuing market standing certificates and non-conviction certificates for notified medical devices in India.This action is being taken to assist Indian medical device importers or manufacturers in submitting their applications for Market Standing Certificates of Notified Medical Devices.This applies to Indian importers and manufacturers of medical devices who wish to get a Market Standing of Notified Medical Devices and who hold a current manufacturing or import license.

      Why Is The Market Standing Certificate Required?

      The market standing certificate basically certifies to the particular medical device manufacturer who has a valid license is allowed to manufacture for sale of various kinds of medical devices. It also verifies that the firm or manufacturer is manufacturing for sale for some particular year.

      What Are The Types Of Market Standing Certificate?

      When you apply to obtain the Market Standing Certificate then you must understand about the two types of Market Standing registry:

      • Domestic Market Standing Certificate – This certificate is issued to the business or companies that work in INDIA or within a jurisdiction of the region from where the certificate is issued.
      • International Market Standing Certificate – The certificate is issued to those businesses or companies that work in multiple countries and jurisdictions.

      Benefits Of CDSCO Market Standing Certificate

      When you apply to obtain the MSC then you must understand the license have multiple benefits for your business and companies:

      • Increased Business Opportunities – CDSCO Market Standing in business is mandatory when a business want to enter in the certain government and public sector tender or contract bid. This will help you to secure higher amount of loans for your business through MSC.
      • Competitive Advantage – When you work to acquire more business opportunities then you will find that MSC certified companies have more competitive advantages over non Certified one.
      • Improved Company Credibility & Reputation – The certificate plays a vital role to improve the company reputation and status in the industry. It boost the company credibility and reputation among the suppliers, investors, and customers. 

      Eligibility To Obtain CDSCO Market Standing Certificate

      A company that activity deal with the manufacturing and selling of the specific product must apply to obtain Market Standing Certificate.

      Who Will Issue The Market Standing Certificate?

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

      What Is The Procedure Of Obtaining The Market Standing Certificate Or The Non Conviction Certificate?

      Manufacturers with active licenses to produce medical devices for sale or distribution must submit an application to the State Drug Controller of the Central Licensing Authority of the Directorate General Health Services.

      • Fill the relevant application form.
      • Prepare and submit necessary documents. 
      • Pay required fee to the government bodies.
      • Regulatory authority will review the application and verify the documents.
      • Once the concerned authority is satisfied then certificate will be issued by the company.

      How Does The Market Standing Certificate Look Like

      This is to certify that M/s.__________________________________________________ are holding license No. _______________valid till________ for manufacture for sale of various kinds of Medical Devices. It is further certified that the firm is manufacturing for sale, ________________________ for the last three years ______, ________, and ________.

      State Drug Controller,

      Certifying & Licensing Authority

      Directorate General Health Services

      List Of Documents Required To Obtain Market Standing Certificate

      • Covering Letter – The purpose of the application should be made crystal apparent 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.
      • 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 licence’s approved product list.
      • Bills of Entry and Import Information (if an import) over the last three years for the products in question.
      • 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.
      • Products that need a Market Standing Certificate list (in compact Disc also).

      What Is The Validity Of The Market Standing Certificate?

      The Market Standing Certificate shall be valid for one year from the date of issuance or until the license expiration date, whichever comes first.