License to Manufacturer for Sale or Distribution of Class A (other than non-sterile and non-measuring) or Class B Medical Device

Deepti Mudgal

Deepti Mudgal

Published on: Mar 26, 2026

Shatakshi Sharma

Updated on: Mar 26, 2026

★★★★★(1 Rating)

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Introduction

A license to Manufacturer for Sale or Distribution of Class A (other than non-sterile and non-measuring) or Class B Medical Device is essential under the Medical Devices Rules, 2017, which is regulated by the CDSCO. It ensures that products meet safety, quality, and performance standards, and grants legal market access.

APPLICABLE PROVISIONS

Rules 5, 6, 7, 20, 22, 26, 29 of the Medical Devices Rules, 2017

WHO CAN APPLY?

1. Degree Holders: A degree in a relevant Engineering branch, Pharmacy, or Science, plus at least two (2) years of experience in medical device manufacturing or testing.
2. Diploma Holders: A diploma in a relevant Engineering branch or Pharmacy from a recognised university, plus at least four (4) years of experience in medical device manufacturing or testing.

DOCUMENTS REQUIRED

1. Power of Attorney
2. Undertaking from the authorised agent

Documents to be submitted by domestic manufacturers or authorised agents with the application for grant of licence to manufacture Class B medical devices:

• Constitution details of the manufacturer or agent
• Site or plant master file (Appendix I)
• Device master file (Appendix II for medical devices or Appendix III for IVDs)
• Essential Principles safety and performance checklist
• Domestic test licenses and quality control data, if any
• Signed undertaking of Fifth Schedule compliance
• Overseas site registration (notarized copy) and Free Sale Certificate from the country of origin as per Rule 36.
• Notarized copy of Quality Management System or Quality Assurance certificates for the manufacturing site
• Valid wholesale or manufacturing license issued under these rules (self-attested copy)
• Latest inspection/audit report (from the last 3 years, if any) by a Notified Body or Regulatory Authority
• For in vitro diagnostic medical devices, a performance evaluation report from a registered laboratory

PROCESS FOR LICENSE

Applicant shall submit Form MD-3 along with the prescribed fee and the required documents to obtain the license to manufacture for sale or distribution of class A (other than non-sterile and non-measuring) or class B medical device. Upon Satisfactory inspection, the licensing authority will issue the license through Form MD-5.

PROCESS OF RENEWAL

The licence shall continue to remain valid without the need for a separate renewal application, provided the licensee deposits the license retention fee as specified in the Second Schedule at intervals of every five years from the date of issue. Updated documents should be submitted only if there are changes in the licensed particulars.

VALIDITY OF LICENSE

The license remains valid indefinitely, provided the retention fee specified in the Second Schedule is paid every five (5) years. Validity is subject to the license not being suspended or cancelled by the Licensing Authority.