How to Manufacture Class A & B Medical Devices in India: State FDA License Guide

A quick guide on the Class A & B Medical Device manufacturing license — covering State FDA rules, Form MD-3/MD-5, fees, and timelines for manufacturers.

Every manufacturer entering India’s device market must secure a Class A & B Medical Device manufacturing license before commercial production begins. This applies specifically to low and low-to-moderate risk devices under the Medical Devices Rules, 2017.

Getting these right upfront saves months of avoidable back-and-forth with regulators. This article walks through eligibility, the application route, documentation, and the real-world timeline for a State FDA Medical Device license covering Class A and Class B products.

Understanding Class A & B Medical Device Manufacturing License

The Central Drugs Standard Control Organisation notified the Medical Devices Rules, 2017, classifying every device into four risk-based categories — Class A, B, C, and D.

• Class A devices carry minimal or no invasiveness, such as thermometers.
• Class B devices are low-to-moderate at risk with limited invasiveness, such as needles and suction cannula.
• Both categories are treated as low risk Medical Device license India cases compared to Class C/D devices.
• Class A devices remain largely self-regulated, though a license is still required for manufacturing.

Who Can Apply for a State FDA Medical Device License

Not every applicant qualifies straightaway. Eligibility is tied to holding a valid manufacturing base and prior licensing.

Any manufacturing company or authorised manufacturer holding a valid Wholesale Manufacturing License can apply. The applicant must intend to manufacture Class A or Class B devices for sale or distribution within India.

The State Licensing Authority, appointed by CDSCO, is the competent body granting this permission. It enforces all norms on manufacture, sale, and stock of these devices across its jurisdiction.

Applying via Form MD-3 MD-5: Step-by-Step

The entire licensing route is built in two forms — the application and the resulting grant of license.

• The manufacturer files Form MD-3 with the State Licensing Authority to request a manufacturing grant.
• Required documents include a cover letter, notarised quality certificates, and the test license used for quality control data.
• Additional filings cover the firm’s constitution, site ownership or tenancy proof, and the Device Master File.
• A signed undertaking confirming Fifth Schedule compliance and the Site Master File must also be submitted.
• The SLA reviews the file, and a Notified Body audits the manufacturing site for Class B devices.
• Once the audit clears, the SLA issues the manufacturing license in Form MD-5..

Table 1: Key Forms for Class A & B Medical Device Manufacturing License

Drug Approval Timeline India Comparison and Fee Structure

While drug approvals and device licenses follow separate regulatory tracks, manufacturers often compare timelines across product categories when planning submissions.

For Class A/B devices, government fees stand at INR 5,000 per manufacturing site, plus INR 500 per individual device. These charges apply regardless of whether the applicant is a domestic or foreign-backed manufacturer.

The license itself carries 5 years expiry, but the applicant must complete a renewal payment before the five-year mark from the date of issue. The State Licensing Authority may suspend or cancel it at any time for valid cause.

Figure 1: Class A & B Medical Device Manufacturing License Process Flow

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Practical Tips for a Smooth Application

A few recurring issues slow down otherwise straightforward applications. Keep these in mind before submission.

• Ensure that the Device Master File and Plant Master File are complete and internally consistent.
• Confirm that the Fifth Schedule undertaking is signed and matches the site details on record.
• Keep the Wholesale Manufacturing License current before filing Form MD-3.
• Prepare for the Notified Body audit well ahead of the review stage for Class B devices.

Since the State Licensing Authority handles both document review and the physical site audit, a well-organised submission reduces the chance of repeated queries.

Conclusion:

• A Class A & B Medical Device manufacturing license is mandatory for any company manufacturing low or low-to-moderate risk devices in India.
• The State FDA Medical Device license is granted by the State Licensing Authority under CDSCO’s Medical Devices Rules, 2017.
• The process runs through Form MD-3 & MD-5 — application and final grant respectively.
• Class A and Class B fall under the low-risk Medical Device license India category, though Class B needs a site audit.
• Government fees are INR 5,000 per site and INR 500 per device.
• The overall timeline typically runs 4-5 months from application to final license.
• The license has 5 years  expiry but needs a renewal payment five years before the issue.