What is an MD 41 & 42 License?

MD 41 42 License

The State Licensing Authority offers the MD 42 Legal Medical Device Registration Certificate to retailers, wholesalers, and stockists, allowing them to sell, stock, exhibit, offer for sale, or distribute medical devices, including In-Vitro diagnostic equipment.

The retailer, wholesaler, or stockiest must submit form MD 41 to the State Licensing Authority to get form MD 42, the Medical Device Registration Certificate. 

What is an MD 41 License?

The State Licensing Authority will issue, approve, or reject the application presented in Form MD-41 (Application for Grant of Registration Certificate to Sell, Stock, Exhibit, or Offer for Sale or Distribute a Medical Device, Including an In Vitro Diagnostic Medical Device)

What Is The Importance of an MD 42 License?

It is important if you are a wholesaler, retailer, and stockiest of medical devices, and this license helps build trust in the products you sell, safe and quality medical devices. 

How do I get my MD 42 license?

Primarily, the State Licensing Authority Issues the MD 42 License after checking all the important items. Furthermore, when convinced that the applicant has followed all the rules and regulations of Medical Devices, the license is provided in Form 42

What Documents are Required for an MD 42 License?

Documents which are needed are mentioned below – 

  • Details of the applicant or firm including its constitution, along with identification proof, such as an Adhar card or PAN card.
  • Documentary evidence in respect of ownership or occupancy on rental of the premises. 
  • Educational Qualification Details of competent technical staff. 
  • Experience Details Of competent technical staff. 
  • A brief description of other activities carried out by the applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises
  • Self-certificate of compliance concerning Good Distribution Compliance.
  • An undertaking to the effect that the storage requirement to sell, stock, exhibit, or offer for sale or distribute a medical device will be complied with 

Any other Documents like GST, Trade License, Premise Plan, etc. 

What is the Government Fee for an MD 42 License?

The government fee for the MD 42 is Rs. 3000, which is required from everyone applying for it. But it’s liable to change according to modifications in updates, so directly talk to the experienced in the field. 

Who Needs To Fill MD 42 License?

  1. Wholesalers of medical items and in vitro diagnostics (IVD)
  2. Retailers of medical devices and IVD
  3. Stockists of medical devices and IVD

What is the Renewal Cost for MD 42 License?

The Client has to pay Rs.3000 for the renewal of the Medical Device Registration Certificate MD 42.

Who Qualifies As Compititent Technical Staff For MD 42 Registration Service?

  • A person who holds a degree from a recognized University/Institution, Who is a registered pharmacist, or Who has passed the intermediate examination with one year of experience in dealing with the sale of medical devices.
  • The Candidate should appoint a Competent Technical Staff to direct and supervise the sales activity of medical devices. The Competent Technical Staff must hold the above educational qualifications and experience.

Why Amazon, Flipkart, and other E-Commerce Portals are Asking for an MD 42 License?

Amazon and Flipkart are requesting an MD 42 license, which is required to sell medical equipment in India. All medical devices imported, produced, or marketed in India require an MD 42 license. The CDSCO issued this license.

Expert Advice

A Medical Device Registration Certificate MD 42 is essential for Wholesalers, Retailers, and Stockists of medical devices. This MD 42 certificate is valid for 5 years. If you are a wholesaler and retailer you must carry the license. For more details and information directly talk to the experts through the mentioned number on the page.

FAQ

What is a wholesale license for medical devices in India?

India’s Medical Devices Wholesale License

The Central Drugs Standard Control Organization (CDSCO) in India uses the CDSCO MD 41 form to register certain medical devices that have an Indian counterpart.

Is a Drug License required for medical devices?

In India, only registered medical devices are regulated as pharmaceuticals under the Pharmaceuticals and Cosmetics Act of 1940 and the Rules of 1945.

What is the MD 42 license used for?

The State Licensing Authority provides the MD 42 Legal Medical Device Registration Certificate to retailers, wholesalers, or stockists so that they can sell, store, exhibit, offer for sale, or distribute medical devices, including in-vitro diagnostic instruments.

What is the Validity of the MD 42 License?

Form MD 42 is valid for five years from the date of the issuance. 

Who is the Consultant for the MD 42 License?

ELT Consultancy is one of the best consultancies in the world, as they have all the experienced members on their team.

ls medical devices online without MD 42 Registration?

No, you can not sell Medical Devices without an MD 42 license.

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