The Medical Device/IVD Wholesale & Retail License, regulated by the Central Drugs Standard Control Organization (CDSCO), is a vital part of India’s medical device regulatory framework. At Medral Global, we assist entities in obtaining this license to ensure compliance with the strict standards that maintain the quality, safety, and efficacy of medical devices and in vitro diagnostics (IVDs) throughout the supply chain.
The Medical Device Rules, 2017, mandate that any entity involved in the wholesale or retail sale of medical devices and IVDs must obtain this license. This regulation is essential to maintain supply chain integrity, prevent substandard or counterfeit products, and guarantee that devices reaching healthcare providers and patients are safe and effective.
Process:
The steps to obtain a wholesale or retail license for medical devices and IVDs include:
- Application Submission: Applicants must submit Form MD-41 to CDSCO, along with required documents such as proof of premises, storage facility details, qualifications of the responsible person, and an undertaking of regulatory compliance.
- Inspection: CDSCO inspects the premises to verify compliance with standards related to cleanliness, temperature control, pest control, and record-keeping.
- Approval: Upon satisfactory inspection and document verification, CDSCO issues the wholesale or retail license in Form MD-42, authorizing the entity to sell specified medical devices and IVDs.
Who can apply for the MD-42 License?
- Importer
- Seller
- Dealer
- Distributor
- Retailer
- Wholesaler
Documents Required for MD-42 Registration:
- Company incorporation certificate
- Partnership deed (for partnership firms)
- Site plan of business premises
- List of partners/directors
- Proof of business premises address
- Utility bills (Electricity/Landline/Water)
- Authorized person’s PAN card or Aadhar card
- GST Registration Certificate copy
- Degree certificate of the competent person
- Experience letter of the competent person
Benefits of Wholesale and Retail Licensing System
The licensing system ensures that only authorized entities handle the distribution of medical devices and IVDs, reducing counterfeit risks and maintaining product quality and safety throughout the supply chain. This safeguards healthcare providers and patients by ensuring the reliability and effectiveness of medical devices.
Additionally, the system promotes transparency and accountability, allowing regulatory authorities to monitor and control device distribution effectively. This helps promptly identify and address any issues, fostering trust in the medical device industry and strengthening India’s overall healthcare system.