Medical Device/IVD Wholesale & Retail License
The Medical Device/IVD Wholesale & Retail License, regulated by the Central Drugs Standard Control Organization (CDSCO), is an integral part of India's medical device regulatory framework. This licence ensures that entities involved in the distribution of medical devices and in vitro diagnostics (IVDs) comply with stringent standards to maintain the quality, safety, and efficacy of these products throughout the supply chain.
The Medical Device Rules, 2017, mandate that any entity intending to engage in the wholesale or retail sale of medical devices and IVDs must obtain a licence. This regulation is crucial for maintaining the integrity of the supply chain, preventing the circulation of substandard or counterfeit products, and ensuring that medical devices reaching healthcare providers and patients are safe and effective.
Process:
The process of obtaining a wholesale or retail licence for medical devices and IVDs involves several steps:
Application Submission: Applicants must submit their application in Form MD-41 to the CDSCO, along with required documents such as proof of premises, details of storage facilities, qualifications of the responsible person, and an undertaking of compliance with the regulatory requirements.
Inspection: The CDSCO conducts an inspection of the premises to ensure they meet the necessary standards for storage and distribution. The inspection evaluates factors such as cleanliness, temperature control, pest control measures, and the adequacy of record-keeping systems.
Approval: If the inspection is satisfactory and all documents are in order, the CDSCO grants the wholesale or retail licence in Form MD-42. This licence authorises the entity to engage in the wholesale or retail sale of the specified medical devices and IVDs.
Who can apply for the MD 42 Licence?
- Importer
- Seller
- Dealer
- Distributor
- Retailer
- Wholesaler
What are the documents required for MD 42 registration?
- Company's incorporation certificate
- Partnership deed, in the case of a partnership firm
- Site plan of the business premises
- List of partners/directors
- Proof of address of the business promises
- Electricity bill/Landline bill/Water bill
- Authorised person PAN card or Aadhar Card
- Copy of GST Registration Certificate
- Degree of a competent person
- Experience letter of a competent person
The wholesale and retail licensing system offers several benefits. It ensures that only authorised entities handle the distribution of medical devices and IVDs, reducing the risk of counterfeit products entering the market. By enforcing strict compliance with regulatory standards, it helps maintain the quality and safety of medical devices throughout the supply chain. This ultimately benefits healthcare providers and patients by ensuring that the medical devices they use are reliable and effective.
Moreover, the licensing system promotes transparency and accountability in the distribution process. It allows regulatory authorities to monitor and control the distribution of medical devices and IVDs, ensuring that any issues can be quickly identified and addressed. This contributes to building trust in the medical device industry and enhances the overall healthcare system in India.