WholeSale License

One of the licenses issued by CDSCO is the Wholesale Licence MD 41-42, which allows a company to Sell, Stock, Exhibit the medical device. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India

This license is important for companies that want to sell, stock, or exhibit medical devices in India. Without this licence, it is illegal to engage in these activities.

Businesses usually have to submit an application to the regulatory body in their nation or state, together with supporting documentation and proof of compliance with the necessary legislation, in order to get a wholesale licence for medical devices.

List Of Documents Required For Medical Device Wholesale License

  •  Identity proof (e.g., PAN card, Aadhaar card)
  •  Document Evidence In Respect of Ownership or Occupancy on Rental of The Premises
  •  Educational Qualification Details of Competent Technical Staff
  •  Experience Details Competent Technical Staff
  •  Brief Description on Other Activities Carried Out by Applicant
  •  Self Certificate of Compliance With Respect To Good Distribution Compliance
  •  An Undertaking to The Effect That The Storage Requirement to Sell,Stock
  •  Any other document like GST,TRADE LICENSE,PremisePlan etc.
  •  Firm should be at Commercial Place

Who Needs Wholesale License For Medical Device?

In India, a wholesale licence is typically required by entities engaged in the wholesale distribution of drugs and medicines.

In How Many Days You Will Obtain The Medical Device Wholesale License In India?

After the submission of the required information, you will be able to get the licence after 90 to 120 working days via CDSCO’s Online System, allowing you to market and distribute the device in India.

Validity Of Sale and Distribution Licence Of Medical Device

The registration certificate issued in Form MD-42 is valid for 5 years from the date of issue.

How Will ELT MediLaw Assist You?

We are proud to provide a wide range of services across the country. Our ELT Medilaw team is well versed in standards of regulatory affairs, enabling the clients to help them sell and distribute their medical devices in the whole country without any compliance difficulties.

We have depth & breadth of understanding and nexus in the regulatory ecosystem across national and internationally. ELT believes in the value of customer satisfaction as its utmost priority and enables the rendering of service in the most smooth manner.