What Is the MD-42 License?

The MD-42 license (also referred to as Form MD-42 or MD 42 registration certificate) is a mandatory regulatory authorization in India for entities involved in the sale, stocking, exhibition, offering for sale, or distribution of medical devices, including in-vitro diagnostic (IVD) devices.

Issued under the Medical Devices Rules, 2017 (as amended by the Fifth Amendment via G.S.R. 754(E) on September 30, 2022), this certificate is provided by the State Licensing Authority (SLA), often referred to as the state-level drug control or FDA equivalent. It ensures compliance with safety, quality, storage, and traceability standards for medical devices across all risk classes (A, B, C, and D).

Key Details

• Who needs it? Retailers, wholesalers, stockists, distributors, importers (in certain contexts), hospitals, pharmacies, diagnostic centers, or any business dealing in the supply chain for medical devices—even if exclusively handling devices and not drugs. This became mandatory starting September 30, 2022, for those without prior equivalent licenses (like Form 20B/21B for drugs).
• Application process: Businesses submit Form MD-41 (application for grant of registration certificate) to the SLA, often via the online Sugam portal. This includes site inspections, document verification (e.g., premises details, storage conditions, responsible person qualifications), and compliance checks. Upon approval, the SLA issues the MD-42 certificate.
• Validity: Typically indefinite (lifetime registration in many cases), but subject to renewals, inspections, or changes in regulations/business details.
• Purpose and benefits: It legalizes operations in India’s growing medical device market (valued at over ₹1.2 lakh crore and expanding in 2026), prevents unauthorized distribution, enforces proper storage (e.g., temperature controls for biologics), and enables traceability from manufacturer to end-user. It also supports import activities in some scenarios (e.g., when paired with other forms like MD-15).

Important Notes and Variations

There is some variation in how sources describe the issuing authority and exact scope:

• Most references (from regulatory consultants, CDSCO-aligned sites, and official amendment explanations) confirm it is issued by the State Licensing Authority for sale/stock/distribution activities (wholesale/retail).
• A few sources mention Central Licensing Authority (CLA) involvement for higher-risk manufacturing (Class C/D), but the core MD-42 form is primarily the registration certificate for distribution/sale, distinct from manufacturing licenses (e.g., MD-5/MD-9 forms).

This is separate from drug licenses (Forms 20B/21B under the Drugs and Cosmetics Act) but serves a similar role for devices. Non-compliance can lead to penalties, seizure of goods, or business restrictions.

If you’re applying for or renewing an MD-42 in India (e.g., as a wholesaler or retailer), consult the latest CDSCO guidelines or a regulatory consultant, as requirements may include premises standards, qualified personnel, and ongoing compliance.

By Mark Smith

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