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MD-42 Registration

Registration of notified medical devices under Form MD-42 for devices listed in the CDSCO schedule.

Import RequirementsManufacturing Requirements

Introduction

MD-42 Registration is the regulatory process for notified medical devices that have been brought under the regulatory ambit through specific CDSCO notifications. Form MD-42 is used for registration of these devices.

Devices covered under MD-42 are those that were previously unregulated but have been notified by the Government of India for mandatory registration. This includes a wide range of medical devices across different risk classes.

This registration is mandatory for manufacturers and importers of notified devices to continue marketing them legally in India.

Why This Service is Legally Required

Registration under MD-42 is mandatory for all notified medical devices as per CDSCO notifications issued under the Medical Devices Rules, 2017.
Devices cannot be manufactured, imported, or sold without valid MD-42 registration after the notification deadline.
Non-compliance results in product seizure and penalties under the Drugs and Cosmetics Act.

Applicable Acts, Rules & Regulations

Primary Legislation

  • Medical Devices Rules, 2017
  • Drugs and Cosmetics Act, 1940
  • Specific CDSCO notifications listing devices requiring MD-42 registration

Supporting Guidelines & Standards

  • CDSCO guidelines for MD-42 submissions
  • Relevant Indian and ISO standards for specific device categories

Governing Authorities and Departments

  • Central Drugs Standard Control Organisation (CDSCO)
  • Drugs Controller General of India (DCGI)

Scope of This Service / Registration

All medical devices listed under CDSCO notifications requiring Form MD-42 registration.
Applicable to both imported and domestically manufactured notified devices.

Import-Related Requirements

Form MD-42 application through CDSCO online portal.
Free Sale Certificate from country of origin.
Authorised Indian Agent appointment.
Product technical documentation.
Performance and safety data.

Manufacturing-Related Requirements

Form MD-42 application for domestic manufacturers.
Manufacturing License from State Drug Licensing Authority.
GMP compliance certificate.
Quality Management System documentation.

Licenses and Approvals Involved

  • MD-42 Registration Certificate from CDSCO
  • Manufacturing License (for domestic manufacturers)
  • Wholesale License for distribution

Documents Required

1Duly filled Form MD-42
2Device description and specifications
3Intended use documentation
4Performance and safety data
5Quality system certificate
6Free Sale Certificate (for imports)
7Manufacturing license copy (for domestic)
8Labelling details

Step-by-Step Registration Process

1

Device Identification

Confirm the device is covered under MD-42 notification and determine applicable requirements.

2

Documentation

Prepare technical documentation, performance data, and quality certificates.

3

Online Filing

Submit Form MD-42 through the CDSCO online portal.

4

Fee Payment

Pay prescribed fees through the portal.

5

Review and Approval

CDSCO reviews the application and grants registration upon satisfaction.

Regulatory Timelines

Indicative timelines: 2-6 months depending on device risk class and documentation completeness.

ℹ️ Timelines are indicative and subject to change based on regulatory authority workload and documentation completeness.

Government Fees

  • Registration fees follow the fee structure prescribed for the relevant device class under the Medical Devices Rules.
  • Fees are payable online through the CDSCO portal.
  • Subject to periodic revision.

ℹ️ Fees are subject to revision by the respective government authorities.

Common Challenges & Compliance Risks

Identifying whether a device falls under MD-42 notification.
Incomplete technical documentation.
Classification disputes for borderline devices.
Meeting notification deadlines for registration.

How Globallex Compliance Helps

Device notification and classification verification.
Complete documentation preparation for MD-42 submission.
Online application filing and fee payment assistance.
Query management and CDSCO liaison.
Ongoing compliance monitoring for new notifications.
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Disclaimer: The information provided on this page is for general informational purposes only and does not constitute legal advice. Regulations, fees, and procedures are subject to change. Please consult with Globallex Compliance for the latest regulatory position and personalized guidance.