MD-5 License for Class-A and B
The MD-5 License is issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017, for manufacturers of Class A and Class B medical devices in India. This license is essential for entities involved in in-house manufacturing or assembling of low to moderate risk medical devices such as thermometers, surgical gloves, syringes, and blood pressure monitors.
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Benefits
Legal Manufacturing Authorization
Operate your medical device manufacturing unit in India without regulatory hassle.Market Access & Distribution
Sell legally to hospitals, retailers, government tenders, and export markets.Regulatory Compliance
Avoid penalties, product recalls, and seizure by maintaining CDSCO standards.Boost Investor & Buyer Confidence
Enhances brand reputation and trust among customers and stakeholders.Access to Government Procurement
Participate in public healthcare and GeM tenders that mandate MD-5 compliance.
🛠️ Process of Registration
Product Classification & Scope Determination
We help you determine whether your product falls under Class A or B as per CDSCO.Document Preparation & Gap Assessment
Our experts assist in compiling technical files, SOPs, QMS documentation, and ISO compliance.Application Filing via CDSCO SUGAM Portal
Submission of Form MD-3 for approval by the State Licensing Authority.Site Inspection & Compliance Check
CDSCO may inspect the premises and verify quality standards.Grant of MD-5 License
Upon approval, Form MD-5 is issued allowing legal manufacturing of specified devices.
Documents Required
Duly filled Form MD-3 Application
Cover Letter with company profile
Manufacturing Site Details & Plant Layout
Device Master File (DMF) & Plant Master File (PMF)
ISO 13485 Certificate
Quality Management System Documents
List of Equipment & Manufacturing Process Flow
Labels, Packaging & Instruction for Use (IFU)
Declaration of Conformity
Name & Qualification of Technical Staff
What You’ll Get
Experts in CDSCO Medical Device Licensing
ISO 13485 Guidance & SOP Preparation
End-to-End Documentation Support
State-Level Coordination & Follow-ups
Post-License Compliance & Renewal Assistance
Frequently Asked Questions
MD-5 is for manufacturers of Class A & B devices, while MD-9 is for importers of medical devices.
The State Licensing Authority (SLA), under CDSCO, issues the MD-5 license.
Yes, ISO 13485 certification is mandatory to demonstrate QMS compliance.
The license is valid indefinitely, subject to the payment of retention fees every 5 years.
Yes, provided they are manufactured at the same facility and fall under Class A or B.
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