Any entity intending to sell, stock, exhibit, or distribute medical devices by wholesale in India must obtain a Registration Certificate in Form MD-42 from the State Licensing Authority (SLA). This rule applies universally, regardless of whether the devices are imported or manufactured domestically.

Key Compliance Requirements

Applying for an MD-42 license requires a specific set of documentation demonstrating the competence and infrastructure of the trading entity:

• Competent Person: You must appoint a competent technical person who holds a degree from a recognized university and has at least one year of experience in dealing with medical devices.
• Storage Infrastructure: Proof of adequate storage facilities, particularly if handling temperature-sensitive devices (e.g., IVD reagents).
• Traceability: Maintaining meticulous records of purchase and sale to ensure batch-level traceability in the event of a recall.

Without an MD-42 license, your distribution network in India is operating illegally and risks immediate seizure of goods.

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