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) | NKB Regovanta
Submit details about the company, facility, responsible personnel, and the proposed medical devices via the CDSCO portal.
Documentation Submission | NKB Regovanta
Upload facility layouts, design dossiers, labeling information, and QMS documentation. ISO 13485 certification is highly recommended to demonstrate QMS compliance.
SLA Inspection | NKB Regovanta
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 | NKB Regovanta
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