Class A & B Manufacturing
(Forms MD-3 & MD-5)
Obtain the essential MD-5 manufacturing license from the State Licensing Authority (SLA) for low-to-moderate risk medical devices.
Consult Our CDSCO Experts
Low & Low-Moderate Risk Devices
Companies established in India intending to manufacture and sell Class A or Class B medical devices (including IVDs) require a manufacturing license from the State Licensing Authority (SLA) under CDSCO's jurisdiction.
Class A: Low Risk
Devices with minimal potential for harm.
- Bandages
- Tongue depressors
- Surgical drapes
Class B: Low-Moderate Risk
Devices requiring standard regulatory controls.
- Stethoscopes
- Syringes
- Standard surgical instruments
The Licensing Process (MD-3 to MD-5)
Form MD-3 is the application submitted electronically, and Form MD-5 is the resulting manufacturing license issued by the SLA upon successful review.
Online Application (Form MD-3)
Submit details about the company, facility, responsible personnel, and the proposed medical devices via the CDSCO portal.
Documentation Submission
Upload facility layouts, design dossiers, labeling information, and QMS documentation. ISO 13485 certification is highly recommended to demonstrate QMS compliance.
SLA Inspection
The State Licensing Authority may conduct an on-site inspection of the manufacturing facility to verify adherence to the Medical Device Rules, 2017.
MD-5 Grant & Validity
Upon approval, the MD-5 license is granted. It is permanently valid, provided the mandatory license retention fees are paid every 5 years.
Simplify Your Application
While Class A & B devices carry lower risk, the regulatory documentation must still be flawless. Our team ensures your MD-3 application is complete and accurate.
- Technical dossier preparation
- QMS (ISO 13485) implementation
- SLA communication & audit support