MD-5 License Class-A and B

Experience a seamless, hassle-free & timely registration with our expert consultants.

✔Our in-house team handles over 50 types of business licenses.
✔We provide end-to-end services across India.
✔Ensuring smooth and continuous adherence to all legal requirements.

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Applicability

MD-5 License is required for:

✔Manufacturers of low-risk (Class A) medical devices
✔Manufacturers of low-moderate risk (Class B) medical devices
✔Companies producing diagnostic kits, surgical instruments, or disposables
✔Entities seeking to sell medical devices through retail or institutional channels
✔Manufacturers applying for government healthcare procurement

Licensing Process

Product Classification & Scope Determination

Determine whether your product falls under Class A or B as per CDSCO guidelines.

Document Preparation & Gap Assessment

Compile 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 and Plant Layout
✔Device Master File (DMF) and Plant Master File (PMF)
✔ISO 13485 Certificate
✔Quality Management System Documents
✔List of Equipment and Manufacturing Process Flow
✔Labels, Packaging and Instruction for Use (IFU)
✔Declaration of Conformity
✔Name and Qualification of Technical Staff

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Rajesh Sharma

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Founder, RS Enterprises

“Bizotic Supervision Private Limited made our GST registration process incredibly smooth. Their team handled everything from documentation to filing, saving us weeks of effort. Highly recommended for any startup!”

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Director, Mehta Foods Pvt. Ltd.

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CEO, Gupta Trading Co.

“From company incorporation to annual ITR filing, Bizotic Supervision Private Limited has been our trusted partner for 3 years. Their pricing is transparent and service quality is consistently excellent.”