Get in Touch

REGISTRATION CERTIFICATE TO SELL, STOCK,
EXHIBIT OR OFFER FOR SALE – MD42

Comprehensive MD 42 Compliance Support for Your Medical Devices

Navigate the path to MD 42 certification with expert guidance and tailored quality management system (QMS) solutions from Medfins International LLP

Get a Free Consultation

What is MD 42?

The MD 42 license, issued by State Licensing Authorities (SLAs), grants permission to retailers, wholesalers, stockists, and importers for sale, stocking, exhibiting, or distributing medical devices in India.
Key areas covered under MD 42:
● Legal Authorization to Sell & Distribute
● Access to a Growing Market
● Eligibility to Partner with Importers
● Structured Business Operations
● Good Distribution Practices (GDP) Alignment

Why It Matters:

An MD-42 license is essential for legally stocking, selling, exhibiting, or distributing medical devices in India under the Medical Device Rules, 2017. It safeguards your business from regulatory action, enables partnerships with manufacturers and importers, and enhances your credibility in a highly regulated market.

Services We Offer Under MD 42

Break down your offerings as a list or grid:

  • ️ Premises & Eligibility Check — Confirm storage, Competent staff, etc.,
  • ️ Verification Of Legal Documents
  • MD 41 Application Preparation
  • ️ Depends on SLA’s either Offline or Online Application Submission
  • ️ Fee Payment Assistance (₹3,000) and SLA tracking
  • ️ Guidance for Audit

Struggling with MDR compliance? Let Medfins guide
you through.

Schedule a Free Call

Why Choose Medfins for MD -42 Compliance?

  • Proven success with Successful MD 42 Certifications
  • Dedicated team for End-to-End Documentation & Implementation Support
  • Fast, Accurate, and Audit-Ready Deliverables

Step-by-Step Process

Visual timeline or steps:

  • Confirm storage, staff, business credentials
  • Collection of technical and legal documents
  • Verification Of Legal Documents
  • MD 41 Preparation & Self-Certify GDP Compliance
  • Application Submission through Offline or Online
  • SLA Review & Site Inspection
  • MD 42 License Issuance

The forms required for Manufacturing License in case of class A and B notified medical devices:

Applicant type

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

Fee Structure:

Applicant Type Application License
Manufacturer Form MD-3 Form MD-5
Test License Form MD-12 Form MD-13

FAQ

Who needs an MD-42 license?
Any entity involved in the retail, wholesale, or distribution of medical devices — including hospitals, pharmacies, stockists, and online sellers — must obtain an MD-42 license, regardless of device class.
Form MD-41 is the application form submitted to the SLA, while Form MD-42 is the actual license issued once your application is approved and your premises meet the required standards.
● PAN & GST certificates
● Premises proof (rental/ownership)
● Qualification proof of technical staff
● Self-declaration for GDP compliance
● Business registration documents and additional documents requested by the SLA’s
The timeline varies by state, but typically around 30 days after submission — depending on document completeness and SLA inspection timelines.

Related Blogs

Case Study 1: U.S. Endotracheal Tube Manufacturer
Case Study 1: U.S. Endotracheal Tube Manufacturer
Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k)…

Read More

MD-27 Permssion
MD-27 Permssion
MD-27 Permssion PurposeMD-26 is the application form used to seek permission from the Central Licensing…

Read More

The Role of Indian Authorized Agent in Medical Device Industry
The Role of Indian Authorized Agent in Medical Device Industry
The Role of Indian Authorized Agent in Medical Device Industry The medical device industry in…

Read More

Get the care you deserve

With our expertise and commitment, you can expect exceptional support for all your regulatory compliance needs.
How this works?
  • Fill out the registration form
  • Schedule a consultation
  • Meet with our regulatory expert
  • Receive tailored guidance
  • Make payment online or via invoice
  • Your project will be initiated by our Executive team

Schedule a Consultation