What is an MD 42 License?
An MD 42 License is issued to entities dealing with low to moderate risk medical devices as categorized under the Medical Device Rules (MDR) 2017. The license ensures that the company meets required safety, quality, and documentation standards before selling or distributing medical devices in the Indian market. This license applies to traders, distributors, stockists, and wholesalers of medical devices.
Eligibility Criteria for MD 42 License
To obtain the license, the applicant must meet certain eligibility conditions:
A registered business entity (proprietorship, partnership, LLP, or company)
Adequate storage facilities for medical devices
A qualified technical person (TP) with the required educational background
Proper documentation of the supply chain and inventory management
A defined process for record maintenance and quality management
Meeting these criteria ensures that the business adheres to the regulatory norms laid out by the CDSCO.
Documentation Required for MD 42 License Registration
Applicants must submit the following documents:
Business registration documents such as GST and incorporation certificates
Details of the technical person
Layout of the premises
Proof of storage facilities
List of medical devices intended for distribution
Undertaking of compliance with MDR 2017
Authority letter and identity proofs
Accurate and complete documentation helps in faster approvals.
MD 42 License Registration Process in Delhi NCR and Haryana
Create Login on CDSCO Portal:
Businesses must first register on the CDSCO Sugam Portal, which serves as the online platform for application processing.Form Submission:
The applicant must fill out the required form (Form MD-42) and upload all documents in the prescribed format.Payment of Government Fees:
The necessary government fees must be paid online during the application process.Inspection (If Applicable):
In some cases, the licensing authority may conduct a site inspection to verify the premises and storage facilities.Approval and Issuance of License:
Upon verification, the authority issues the MD-42 License, allowing lawful distribution of medical devices.
Why MD 42 License is Important?
The license helps ensure transparency, regulatory compliance, and accountability in the medical device distribution chain. It also boosts business credibility and enables companies to partner with reputable manufacturers and hospitals.
Agile Regulatory – Your Trusted Partner for MD 42 License Registration
Agile Regulatory offers professional assistance for obtaining the MD 42 License in Delhi NCR and Haryana, ensuring a smooth and error-free process. From preparing documents and managing portal filings to guiding you through compliance requirements under MDR 2017, our team handles every step with precision. Businesses rely on us for timely approvals, expert support, and an end-to-end hassle-free experience. With Agile Regulatory, you get reliable consultation and complete regulatory support tailored to your business needs.
