MD-42 License Registration in Uttar Pradesh: A Complete Guide for Manufacturers
The medical device industry in India is rapidly expanding, and with this growth comes the need for proper regulatory compliance. In Uttar Pradesh, manufacturers dealing with specific categories of medical devices must obtain the MD-42 License, a mandatory approval issued by the State Licensing Authority (SLA) under the Medical Device Rules (MDR), 2017. This license is particularly required for manufacturers producing non-notified Class A medical devices at the state level. Understanding the process, documentation, and compliance requirements can help businesses avoid delays and operate smoothly.
What is an MD-42 License?
The MD-42 License is a manufacturing license granted to entities involved in the production of Class A medical devices that fall under the State Authority’s purview. Unlike higher-risk categories (Class B, C, and D), which require CDSCO approval, the MD-42 license ensures compliance at the state regulatory level. It certifies that the manufacturer follows quality management systems, safety practices, and regulatory standards mandated by MDR-2017.
Why is MD-42 Registration Important?
Manufacturing medical devices without a valid license is a violation of Indian regulatory law. Obtaining the MD-42 License helps a business:
Operate legally within Uttar Pradesh
Improve credibility among buyers and distributors
Meet institutional tender requirements
Maintain adherence to regulatory protocols
Build trust in the healthcare supply chain
In a competitive medical device market, compliance not only protects your business but also supports long-term sustainability.
Eligibility Criteria
To apply for the MD-42 License, a manufacturer must:
Have a dedicated and compliant manufacturing facility
Appoint a competent Technical Person (TP) with required qualifications (Pharmacy, Engineering, Biomedical, etc.)
Maintain quality control systems
Ensure the premises meet Good Manufacturing Practices (GMP) guidelines
Documents Required for MD-42 License Registration
Businesses must prepare the following documents:
Completed application form under the MD-42 category
Constitution documents: Partnership Deed / MOA / AOA / Proprietor ID
Manufacturing site layout plan
List of machinery and equipment
Details of Quality Management System (QMS)
Technical staff qualification certificates
Device Master File (DMF) and Plant Master File (PMF)
Proof of manufacturing premises
Undertaking of compliance with MDR-2017
Preparing accurate documentation is crucial as errors can result in application rejection or delays.
Step-by-Step Registration Process
Preparation of Documents – Gather all compliance papers, technical documents, and details of the manufacturing premises.
Online Application on the State Portal – Submit the application under the MD-42 medical device manufacturing category.
Scrutiny by State Licensing Authority – The authority reviews documents and may request additional details.
Site Inspection – A physical inspection is conducted to verify compliance with QMS and facility standards.
Issuance of MD-42 License – Upon successful review and inspection, the SLA grants the license.
How Agile Regulatory Helps
Agile Regulatory specializes in providing complete assistance for MD-42 License Registration in Uttar Pradesh. From documentation support and portal filing to coordination with the State Licensing Authority, our team ensures a smooth and efficient approval process. We help manufacturers understand regulatory requirements and stay compliant under MDR-2017 with professional guidance at every step. For expert consultation and hassle-free licensing services, Agile Regulatory is the trusted partner for medical device businesses across India.