What is Sale and Purchase License (MD-42)?
Form MD-42 is a Registration Certificate issued by the State Licensing Authority under the Medical Devices Rules, 2017, for entities involved in selling, stocking, exhibiting, offering for sale, or distributing medical devices in India. This license is crucial for ensuring that all entities involved in the medical device supply chain maintain proper storage conditions, employ qualified technical personnel, and follow record-keeping requirements set by the regulatory authority. Its importance lies in maintaining the safety and efficacy of medical devices as they move from manufacturers to end users.
When Do You Need Distribution Compliance Support?
Support for wholesalers, distributors, retailers, importers, and online sellers handling medical devices in India.
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Medical Device Wholesalers & Distributors
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Medical Device Retailers
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Importers Engaged in Domestic Distribution
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Institutional Suppliers
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Stockists & Storage Facilities
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Entities Offering Medical Devices for Sale Through Online Channels
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Incomplete technical documentation
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Non-compliant labelling and Instructions for Use (IFU)
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Understanding QMS and distribution compliance requirements.
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Delays caused by CDSCO queries
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Errors during portal submission
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Insufficient technical evidence for products
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Delays in inspection or review processes
Our Approach and What You Will Get
Structured support for product classification, documentation review, CDSCO submission, query handling, and post-license compliance for MD-42.
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Product classification assessment
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Regulatory strategy development
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Evaluating supplier documentation and distribution compliance.
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Documentation gap analysis
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Preparation and review of required regulatory documentation
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Review of label and IFU compliance
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Support with agreements and authorizations
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Submission via online CDSCO portal
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Handling government queries
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Comprehensive regulatory coordination
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Regulatory applicability assessment for MD-42
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Device classification guidance
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Documentation checklist and gap analysis
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Review of business and premises documents
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Competent person eligibility check
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Storage and infrastructure compliance advice
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Preparation of MD-42 application documents
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Assistance with State Licensing submissions
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Support for regulatory query responses
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Coordination until license approval
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Guidance on labelling and distribution compliance
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Post-license compliance and record-keeping support
Why Choose Tacit Medtek and Case Example
End-to-end regulatory support for medical device distribution licensing, compliance, documentation, and submission management in India.
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Skilled regulatory affairs professionals
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In-depth knowledge of CDSCO medical device regulations
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Complete end-to-end project management
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Support for startups and established firms
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Expertise in documentation and compliance
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Timely coordination with clear communication
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Tailored regulatory solutions
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Assistance for various device categories
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Emphasis on compliance and speedy execution
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Challenge: A healthcare distribution startup intended to wholesale surgical disposable medical devices in India but was unclear about the licensing requirements under the Medical Devices Rules, 2017. They also struggled with documentation preparation, appointing qualified competent technical person, and meeting storage and record-keeping compliance for regulatory approval.
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Our Approach: We performed a thorough regulatory assessment, identified licensing requirements, prepared the MD-42 application, reviewed business and premises compliance, advised on technical competent person eligibility, and supported the client through submission and query handling with the State Licensing Authority.
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Outcome: The client successfully obtained the MD-42 Registration Certificate for sale and distribution of medical devices, allowing lawful stocking and wholesale of surgical disposable products in India, while enhancing operational compliance and regulatory preparedness.
FAQ
Frequently Asked Questions
A medical device can be imported into India by an entity holding a valid Import License issued under MDR 2017 (Form MD-15), along with compliance with applicable regulatory requirements.
No. If the trader/distributor is involved exclusively for stock, sale and distribution of medical device only, then they are required to obtain Form MD-42.
The concerned State Licensing Authority.
The State Licensing Authority may process and issue Form MD-42 within the prescribed timeline under MDR 2017, subject to satisfactory review of the application and documents.
The registration certificate remains valid perpetually, subject to payment of retention fee as applicable under MDR 2017.
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