Manufacturing License (MD-5): Class A & B
The State Licensing Authority grants the Manufacturing License in Form MD-5 as per the Medical Devices Rules, 2017 for Class A (low-risk) and Class B (low-moderate risk) medical devices. The application is submitted via Form MD-3, followed by evaluation of the manufacturing site, quality management system, and technical documentation. MD-5 legally permits the production and marketing of these devices in India, ensuring compliance with CDSCO quality and safety requirements. Obtaining this license helps manufacturers avoid regulatory penalties, facilitates smooth market entry, and builds credibility with healthcare professionals and customers.
When Do You Need MD-5 Support
and What Are the Key Challenges?
Support for manufacturers preparing to commercialize Class A or B medical devices under the Medical Devices Rules, 2017.
-
When the medical device design or prototype is finalized and ready for commercial production
-
Before manufacturing, assembling, or processing Class A or B medical devices
-
Prior to sale, distribution, or marketing in India
-
When establishing a new manufacturing facility
-
When adding new Class A or B devices to an existing product line
-
To demonstrate compliance with Medical Devices Rules, 2017
-
To implement a quality management system (ISO 13485) for manufacturing operations
-
Regulatory Complexity
-
Incorrect Classification
-
Documentation Errors
-
GMP & Infrastructure Requirements
-
Regulatory Queries & Delays
Our Approach and What You Will Get
Structured support for device classification, documentation, GMP readiness, and state-level licensing approval for medical device manufacturing.
-
Device classification and regulatory pathway assessment
-
Gap analysis and documentation preparation (DMF, PMF, SOPs)
-
Filing the MD3 application and coordinating with the State Licensing Authority
-
GMP compliance support and ISO 13485 implementation
-
Query handling, inspection readiness, and end-to-end approval support
-
Complete Licensing Support
-
Accurate Documentation & Dossier Preparation
-
Faster & Smoother Approvals
-
GMP & Facility Compliance Guidance
-
Dedicated Regulatory Expertise
-
End-to-End Coordination
-
Post-License Support
Why Choose Tacit Medtek and Case Example
End-to-end support for Loan License applications, compliance planning, documentation, and regulator coordination for medical device businesses.
-
Expert knowledge of CDSCO regulations and licensing
-
Complete support for Manufacturing License documentation
-
Focus on minimizing delays and regulatory issues
-
Help with application preparation, review, and submission
-
Strong emphasis on quality and compliance
-
Timely project management and client support
-
Experience with diverse medical device categories
-
Guidance to simplify and speed up approvals
-
Efficient coordination for faster outcomes
-
Dedicated to a smooth and successful licensing process
-
Challenge: A startup medical device company planned to manufacture a Class B digital thermometer in India but lacked clarity on regulatory requirements, documentation, and the State Licensing Authority submission process under the Central Drugs Standard Control Organization (CDSCO).
-
Our Approach:
- Verified device classification and applicable regulatory pathway for MD-5.
- Conducted gap analysis for Quality Management System (ISO 13485 readiness).
- Prepared complete MD-5 application, including Device Master File, Plant Master File, and labeling compliance.
- Coordinated with State Licensing Authority and supported query resolution during review.
-
Outcome:
- The client successfully obtained the MD-5 Manufacturing License within 4-5 months.
- Enabled compliant production and smooth market entry in India.
FAQ
Frequently Asked Questions
Yes. CDSCO has established support mechanisms to assist startups, innovators, manufacturers, and importers regarding regulatory procedures and medical device approval pathways. Applicants may contact the CDSCO Public Relation Office (PRO) Cell for general regulatory guidance.
- PRO Cell: CDSCO PRO Cell
- Email: startupinnov@cdsco.nic.in
Generally, fees submitted for medical device licence applications are non-refundable under the Medical Devices Rules, 2017, even if the application is withdrawn or cancelled.
Yes. Manufacturers may use laboratories recognized or registered under applicable CDSCO requirements for device testing, evaluation, or performance verification.
Audits of manufacturing facilities for applicable Class A and Class B medical devices are conducted by Notified Bodies authorized and registered by CDSCO.
Manufacturing Licence applications for Class A and Class B medical devices are submitted to the respective State Licensing Authority where the manufacturing facility is located.
Inspection requirements depend on the device category and risk classification. Certain Class A devices may qualify for simplified review, while audits or inspections are commonly applicable for Class B devices and specific Class A categories such as sterile or measuring devices.
The concerned licensing authority generally assigns the applicable CDSCO-registered Notified Body during the application review process.
Yes. Manufacturers are generally required to provide declarations or undertakings confirming that their manufacturing site complies with applicable requirements under the Medical Devices Rules, 2017.
Yes. Devices intended exclusively for export should be appropriately identified in the application and related documentation as export-only products.
Manufacturing Licences issued under the Medical Devices Rules, 2017 generally remain valid unless suspended or cancelled, subject to compliance with applicable retention fee and regulatory requirements.
Enquire Now
Fill in the form and our team will get back to you shortly.
Reach our regulatory experts directly.