A Class B manufacturing licence is mandatory if you plan to manufacture low-moderate risk medical devices in India under the Medical Devices Rules, 2017 (MDR 2017). Class B devices are regulated by the State Licensing Authority (SLA).

This detailed guide covers the entire process, from classification to licence grant, so you can apply correctly and avoid common rejections.

What Devices Need a Class B Manufacturing Licence?

Class B medical devices are low-to-moderate risk devices. Common examples include:

• Hypodermic needles and syringes
• Blood pressure monitors
• Surgical gloves (sterile)
• Urinary catheters
• Suction equipment
• Hearing aids
• Ultrasound transducers

The exact classification is decided based on the parameters given in the First Schedule of MDR 2017 and the latest CDSCO Class-wise list.

Who Grants the Class B Manufacturing Licence?

• Authority: State Licensing Authority (State Drugs Controller)
• Application Form: Form MD-3 (regular licence) or Form MD-4 (Loan Licence)
• Licence Issued in: Form MD-5 (regular) or Form MD-6 (Loan Licence)

Step-by-Step Process to Get Class B Manufacturing Licence

Step 1: Confirm Device Classification

Verify that your device is Class B using the CDSCO Class-wise list and First Schedule parameters. Wrong classification is one of the most common reasons for rejection.

Step 2: Ensure Quality Management System (QMS) Compliance

Your manufacturing site must comply with the Quality Management System requirements specified in the Fifth Schedule of MDR 2017. Most manufacturers implement ISO 13485:2016 as it aligns closely with these requirements.

Step 3: Appoint Competent Technical Staff

You must appoint:

• Manufacturing in-charge: Degree in relevant Engineering / Pharmacy / Science + 2 years experience or Diploma + 4 years experience
• Testing in-charge: Degree / Diploma in relevant field + minimum 2 years testing experience

Step 4: Prepare Required Documents

Key documents for your Class B manufacturing licence application include:

• Covering letter
• Duly filled Form MD-3 / MD-4
• Constitution documents of the firm
• Site / Plant Master File (Appendix I of Fourth Schedule)
• Device Master File (Appendix II or III of Fourth Schedule)
• Essential Principles Checklist
• Undertaking for QMS compliance (Fifth Schedule)
• Layout of manufacturing premises
• List of equipment and instruments
• Details of technical staff
• ISO 13485 certificate (highly recommended)
• Fee challan

Step 5: Submit Online Application

Submit the application through the designated online portal of the Ministry of Health & Family Welfare / CDSCO along with the prescribed fee.

Step 6: Notified Body Audit

For Class B devices, a registered Notified Body must audit your manufacturing site for QMS compliance.

• Audit should be completed within 90 days of application
• Notified Body submits the audit report to the State Licensing Authority within 30 days of audit completion

Step 7: Scrutiny & Grant of Licence

The State Licensing Authority scrutinises the documents and audit report. If everything is satisfactory, the Class B manufacturing licence is granted in Form MD-5 (or MD-6 for loan licence) within 20 days of receiving the audit report.

Important Timelines for a Class B Manufacturing Licence

Class B Manufacturing Licence Validity & Retention Fee

The licence remains valid in perpetuity, subject to payment of licence retention fee every 5 years as specified in the Second Schedule of MDR 2017.

Common Reasons for Class B Manufacturing Licence Rejection

• Incomplete or incorrect Device Master File / Plant Master File
• Non-compliance with Fifth Schedule (QMS)
• Lack of qualified technical staff
• Improper classification of device
• Incomplete Essential Principles Checklist

Class B Manufacturing Licence FAQs

How long does a Class B manufacturing licence take?

The Notified Body audit is due within 90 days of application, and the licence is granted within 20 days of the audit report reaching the State Licensing Authority. Document scrutiny time varies by state.

Who issues the Class B manufacturing licence?

The State Licensing Authority (State Drugs Controller) issues it in Form MD-5, or MD-6 for a loan licence.

How Satori OCS Can Help You

Navigating the Class B manufacturing licence process requires accurate documentation, proper QMS implementation, and coordination with Notified Bodies and the State Licensing Authority.

At Satori One Click Solutions (Satori OCS), we provide end-to-end support for medical device manufacturers, including:

• Device classification support
• Preparation of Plant Master File & Device Master File
• QMS (ISO 13485) gap assessment and implementation
• Complete documentation for Form MD-3 / MD-5
• Coordination with Notified Bodies
• Liaison with State Licensing Authorities

We have successfully helped multiple clients obtain manufacturing and import licences under MDR 2017.