REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE – MD42

Medfins International > Services > REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE – MD42

REGISTRATION CERTIFICATE TO SELL, STOCK, EXHIBIT OR OFFER FOR SALE OR DISTRIBUTE A MEDICAL DEVICE INCLUDING IN VITRO DIAGNOSTIC MEDICAL DEVICE

To legally sell, stock, exhibit, offer for sale, or distribute medical devices, including in vitro diagnostic (IVD) devices, in India, obtaining a Registration Certificate is mandatory. 

Who Needs to Apply: Any individual or entity involved in the retail, wholesale, or distribution of medical devices or IVDs in India must secure this Registration Certificate. This requirement applies to those without existing licenses under Forms 20B and 21B of the Drugs and Cosmetics Rules, 1945. 

Application Process:

  1. Form MD-41 Submission: Applicants must submit Form MD-41 to the respective State Licensing Authority (SLA), expressing intent to sell, stock, exhibit, or distribute medical devices. 
  2. Required Documentation:
    • Applicant Details: Information about the applicant or firm, including constitution details and identification proof (e.g., Aadhaar card, PAN card).
    • Premises Proof: Ownership documents, rental agreements, Blueprint of the business premises.
    • Competent Technical Staff (CTS): Details of appointed CTS, including educational qualifications and experience certificates. The CTS should possess:
      • A degree from a recognized university/institution, or
      • Registration as a pharmacist, or
      • Completion of an intermediate examination with at least one year of experience in medical device sales. 
    • Good Distribution Practice Compliance: A self-certification confirming adherence to Good Distribution Practices.
    • Storage Compliance Undertaking: A commitment to maintaining appropriate storage conditions for medical devices.
  3. Fee Payment: A fee of ₹3,000 is payable to the SLA upon application submission. 
  4. Application Review: The SLA will review the application and, if satisfactory, issue the Registration Certificate in Form MD-42. Post-Approval Requirements:



  • Display of Certificate: The Registration Certificate must be prominently displayed at the business premises.
  • Maintenance of Records: Accurate records of all purchases and sales, including details like product names, quantities, batch numbers, and expiry dates, must be maintained.
  • Storage Conditions: Adequate space and proper storage conditions, including appropriate temperature and lighting, must be ensured for all medical devices. 

Validity and Renewal: The Registration Certificate remains valid indefinitely, provided a retention fee of ₹3,000 is paid every five years from the date of issuance. 

Note: The mode of payment and application submission will depend on the respective state authority, as it can be online or offline.

FAQs:

  • Can a single MD-42 cover multiple locations?

No, MD-42 is issued for a specific premises. If you operate multiple locations, a separate registration is required for each.

  • How long does it take to get MD-42?

The timeline varies by state, but the State Licensing Authority (SLA) is expected to process the application within one month.

 

How can Medfins help you?

We can assist in obtaining MD-42 (Registration Certificate to Sell, Stock, Exhibit, or Distribute Medical Devices Including IVDs) by ensuring compliance with the regulatory requirements and streamlining the application process. 

  1. Eligibility Assessment
  • Evaluates whether the applicant meets the eligibility criteria (e.g., qualified Competent Technical Staff, proper storage facilities).
  • Advises on any gaps that need to be addressed before submission.
  1. Documentation Preparation
  • Assists in preparing and compiling required documents, such as:
    • Form MD-41 (Application for Registration)
    • Business registration documents (Company Incorporation Certificate, GST, etc.)
    • Competent Technical Staff (CTS) details (Qualification, Experience Certificates)
    • Proof of premises (Rental Agreement, Ownership Certificate)
    • Good Distribution Practice (GDP) self-certification
    • Undertaking for proper storage and handling of medical devices
  1. Application Submission
  • Determines whether the application should be submitted online or offline based on the state’s regulatory system.
  • Guides in fee payment (₹3,000) through the correct mode (online or offline).
  • Ensures proper formatting and compliance to avoid delays or rejections.
  1. Follow-up with Authorities
  • Liaises with the State Licensing Authority (SLA) to track the application’s progress.
  • Responds to any queries or deficiencies raised by the SLA.
  1. Post-Approval Compliance
  • Ensures that MD-42 is displayed at the business premises.
  • Guides on maintaining records as per regulatory requirements.