Medical Device Manufacturing License (MD-42) in Uttar Pradesh – Step-by-Step Guide

If you're planning to start or already operating a medical device retail or wholesale business in Uttar Pradesh, securing the MD-42 License is a legal mandate. As per the Medical Device Rules, 2017, this license is essential for selling, distributing, or exhibiting for sale any Class A or B medical devices in India.

In this article, we’ll walk you through everything you need to know about the MD-42 License in Uttar Pradesh – from eligibility to documents, process, and compliance requirements.

What is MD-42 License?

The MD-42 License is issued under the Medical Device Rules, 2017 by the State Licensing Authority (SLA). It is applicable for entities involved in the sale, stock, exhibition, offering for sale, or distribution of Class A and B medical devices.

This license is crucial for:

• Retailers

• Wholesalers

• Distributors

• Optical & Contact Lens Shops

• Medical Equipment Stores

Without this license, operating such a business in Uttar Pradesh is deemed illegal and can attract penalties under the Drugs and Cosmetics Act.

Who Needs MD-42 License in Uttar Pradesh?

Any individual, firm, or organization intending to sell, stock, or distribute medical devices in UP must obtain the MD-42 license. This includes:

• Optical shops selling lenses and frames

• Pharmacies selling devices like BP monitors, thermometers, syringes, etc.

• Distributors of diagnostic kits or surgical equipment

• E-commerce retailers dealing in medical devices

Psr Compliance is a leading consultancy firm specializing in regulatory compliance, certifications, and licensing for businesses across India.