Explore

close

All Categories

    • New year 2022 celebration started

      New year 2022, event booking, hotel booking and more

    • Home cleaning services near you

      Home cleaning, pet control, home cleaning services near me, professional house cleaners, local home cleaning service, residential cleaning services, maid service near me, deep cleaning home service, affordable house cleaning, eco-friendly home cleaning, same day cleaning service, apartment cleaning near me, trusted home cleaners, local maid services, house cleaning and sanitizing, move-in cleaning, move-out cleaning, kitchen and bathroom cleaning

    • Software jobs waiting for you

      Jobs in New york, High pay salary

    • Spa Center For Womens

      No:2, 4th Avenue, Newyork, USA, Near to Airport

    • Online classes for School Students

      Schools, university, colleges, online classes, tution centers, distance education..

    • Buy Iphone13 Pro now

      Iphone 13, 12, 11 and all apple product available

    • Now easy to buy Villas, Plots and Flats

      Greater Noida

    • Best AC Service Expert near you

      Service expert, ac service, best AC service near me, AC repair expert near me, air conditioner technician nearby, local AC service provider, split AC repair near me, window AC service near me, emergency AC repair near me, AC installation and maintenance, affordable AC service expert, certified AC technician near me, air conditioning repair service, same day AC service near me, home AC servicing near me, AC gas refill service near me, HVAC expert near me
menu
close

All Categories

 

Send enquiry

Get Your Medical Device Wholesale License with Agile Regulatory

12, Apr 2025 70

What is a Medical Device Wholesale License?

A Medical Device Wholesale License (Form MD-42) is issued by the State Licensing Authority (SLA) under the Medical Devices Rules, 2017. It allows a business to legally sell, stock, exhibit, or distribute Class A and Class B medical devices in India.

If you’re involved in the wholesale or distribution of items like thermometers, BP monitors, syringes, or surgical gloves, this license is mandatory. Selling medical devices without it is a punishable offense under the Drugs and Cosmetics Act.

Who Needs This License?

This license is required by:

  • Distributors or wholesalers dealing in Class A or B medical devices

  • Pharmacy chains and online medical stores

  • Hospitals and clinics that supply medical devices

  • Importers who want to distribute devices in India

  • Startups entering the medical device distribution market

Agile Regulatory offers tailored guidance based on the size and structure of your business.

Classification of Medical Devices

India classifies medical devices based on their risk levels:

ClassRisk LevelExamplesALowBandages, surgical dressings, thermometersBLow to ModerateBP monitors, nebulizers, syringesCModerate to HighInfusion pumps, dialysis machinesDHighHeart valves, pacemakers

MD-42 license is only required for Class A and Class B devices. For Class C and D devices, different approvals apply (like Form MD-43).

Why Work with Agile Regulatory?

We understand that getting a license from a government body can be intimidating. That’s where Agile Regulatory comes in. We have the experience, systems, and team to get your license approved fast—with complete transparency.

Here’s how we help:

✅ End-to-End Assistance
From document preparation to final approval, we handle everything.

✅ Expert Guidance
We help you identify your product class and ensure proper categorization.

✅ Fast Processing
Our team knows the steps, follow-ups, and best practices to speed things up.

✅ PAN India Service
Whether you're in Delhi, Mumbai, Bengaluru, or a smaller city—we can assist you remotely.

Key Requirements for the License

To get an MD-42 license, you’ll need to meet certain basic infrastructure and staffing criteria:

1. Suitable Premises

  • Adequate storage space with good ventilation

  • Clean and dust-free environment

  • Refrigeration (if required for certain devices)

  • Racks and fire safety measures

2. Qualified Technical Staff

You must appoint a “competent person” who:

  • Holds a degree in Pharmacy, Science, or related field

  • Has at least 1 year of experience in sales/distribution of drugs or medical devices

We can assist in evaluating or arranging suitable staff for your license application.

Documents Required

Here’s a list of documents you’ll typically need:

For the Company:

  • Business registration certificate (Proprietor/LLP/Pvt Ltd)

  • PAN Card and GST certificate

  • Rent agreement or ownership proof for premises

  • Site layout/blueprint

For the Competent Person:

  • Degree certificate

  • Experience certificate (at least 1 year)

  • ID and address proof

  • Appointment letter and resume

Other:

  • List of medical devices to be sold

  • Cold storage equipment (if needed)

  • Declaration forms

Agile Regulatory provides full support to ensure that all documents are in the correct format, verified, and ready for submission.

Step-by-Step Process with Agile Regulatory

Getting the MD-42 license involves multiple steps. We make it seamless:

Step 1: Free Consultation

We start with a call to understand your product range, business type, and eligibility.

Step 2: Document Preparation

Our experts guide you in compiling and organizing all required documents.

Step 3: Online Application

We register your company on the CDSCO’s SUGAM portal and file the MD-42 application.

Step 4: Site Inspection

A Drug Inspector may inspect your premises. We help prepare for this visit and ensure compliance with layout, hygiene, and equipment requirements.

Step 5: License Approval

If everything is in order, your Form MD-42 license will be issued. It has perpetual validity, subject to periodic fee payment every 5 years.

Government Fee Structure

As per the Medical Devices Rules, the standard government fee is:

  • ₹3,000 for license application

  • ₹500 as inspection fee (if applicable)

Our consulting charges vary based on scope and location. Get in touch for a transparent quote.

Timeline for License Approval

Typically, the license process takes 30–45 working days. This can vary depending on document readiness and inspection timelines.

With Agile Regulatory, we ensure that delays are minimized through proactive coordination and tracking.

What Happens After Getting the License?

Once your license is issued:

  • You can legally stock, sell, and distribute Class A & B medical devices.

  • Maintain records of sales and purchases.

  • Keep your storage and display conditions in compliance.

  • Update licensing authorities if there are any changes to the premises or staff.

We also offer post-license compliance support to help you stay audit-ready at all times.

Why Our Clients Trust Agile Regulatory

Here’s what sets us apart:

  • 🎯 5+ years of experience in regulatory licensing

  • 🔍 Deep knowledge of medical device classifications

  • 📍 PAN India presence – remote and on-ground support

  • 🧾 100% documentation accuracy

  • 🕒 Quick turnaround time

  • 📞 Dedicated relationship manager

Whether you’re setting up your first distribution outlet or scaling your operations across states, we’re with you at every step.

Ready to Start?

Getting a Medical Device Wholesale License doesn’t have to be overwhelming. With Agile Regulatory, you’ll have a reliable partner who knows the process inside and out.

Let us handle the legalities while you focus on building your business.

Agile Regulatory

Joined on 08, Aug 2025  

Other Post

Related Posts

  • Hair Care Clinic in Madurai - Renew Hair and Skin Care

  • Which is the most trusted institute for CA Intermediate preparation in Bangalore?

  • Buy Verified PayPal Accountsv

  • Purchase Effective Progesterone Capsules in the Middle East

  • Why Regular Visits to a Physician Are Essential for Your Health

  • Sexologist doctor near me

  • Turkey SMM Panel in 2026

  • Reddy Anna

  • real estate builders in Chennai - Traventure Homes

  • Unlock Business Success with a CRM Users Email List

  • How Business Directories Can Boost Your Online Visibility

  • Learn everything about Farmtrac 60, Sonalika 750, Sonalika 60, and New Holland tractors

  • Protect Your Property With the Help of Waterproofing Services in Mohali | Chandigarh | Tricity

  • Author Jones

  • Comparing Direct Drive and Gearbox Wind Turbines: Which Is Right for the Future?

  • Radhakrishna Netralay & Superspeciality Eye Hospital

  • Sildalist 120mg: Affordable Solution for Erectile Dysfunction (ED) Issues

  • Chia Seeds

  • Your Trusted Pharmacy Near Ludhiana Pavilion Mall – Guardian Pharmacy

  • E-commerce Website and App Development Services in Dubai – Levon Venture Solutions

  • Where to Buy Healthy Cookies That Actually Taste Great

  • Expert Labour Laws Compliance Services in Noida – Gupta & Company Consultants

  • Bladder Cancer Treatment in Yamunanagar with GM Oncology Team

  • Rediscover Balance - Iyengar Yoga Retreat Journey with AdiYogum

  • Book a Taxi from Pune to Lonavala for a Relaxing Getaway

  • Bangalore to Adiyogi Chikkaballapur by Taxi – A Divine Road Trip

  • The Ultimate Guide to PPF for Auto Why Car Paint Protection Film is Worth It

  • Best Hair Salon in Yamunanagar: Style, Quality & Care You Can Trust

  • Shreyan1122

  • Your Dream Starts Here: Internships in France with a Culinary Twist

  • Why Do We Need Pest Control? 10 Reasons You Shouldn’t Ignore It

  • Embrace Your Beauty with Confidence at Hair By Saha

  • ommurugacateringservice

  • Hinex ST Complete Balanced Nutrition 400g

  • https://zekond.com/

  • Online Iowa MMJ Card Doctor for Fast Approval

  • Season of Rejuvenation: How Monsoon Boosts the Power of Ayurveda Treatments

  • DEAN Foundation: Compassionate Hospice & Palliative Care Services

  • Best Residential Interior Designers in Gurgaon

  • Boost Visibility & Credibility with PRWeb

  • Renewal Master Program. PDU In this 60 PDU pack, we have princ2 certification, six sigma certificati

  • Kashmiri Saffron Online | Nimbark Foods

  • Medical Billing Services in California – Optimize Your Revenue Cycle with DocsMed

  • Frazier Pest Control – Your Neighborhood Pest Professionals

close

What service do you need? Fairsearches will help you

List your business for FREE

List your business for FREE with FairSearches! Gain visibility, connect with customers, and enjoy unbiased, reliable results. Our platform helps you grow without hidden fees. Start today and take your business to the next level with transparent, fair search solutions.

Add my business arrow_forward

Free support: +91 8750 299 299   |   Email: admin@fairsearches.com

Top Category

Trending Category

HELP & SUPPORT

Popular Tags

Get In Touch

Address: A-12 B. D. Enclave Yusufpur Chak Saberi Greater Noida 201009

Phone: +91 8750 299 299

Email: admin@fairsearches.com

Dharam Vir Infotech Private Limited

Dharam Vir Infotech Private Limited collaborates with Fairsearches.com to deliver innovative digital solutions and lead-generation services.

SOCIAL MEDIA

Copyright © 2014 Proudly powered bylogique soft.