The MD-03 application form is submitted to the State Licensing Authority to apply for a license to manufacture or import medical devices. Upon approval, the MD-5 certificate is granted for manufacturing purposes.

• Examples of Class A (Sterile/Measuring) Devices:
  • Amino acid analyzers
  • Lipid profile analyzers
  • Breath-alcohol test systems
  • Osmometers
  • Blood cell count analyzers
  • Sterile dental dressing forceps
• Examples of Class B Devices:
  • Spirometers
  • Oxygen concentrators
  • Blood pressure monitoring devices
  • Digital thermometers

1. Application Submission: Submit the MD-03 application via the Ministry of Health and Family Welfare's online portal, including all required documents.
2. Quality Management System (QMS) Compliance: Ensure that the manufacturing facility meets QMS standards. Class A devices do not require an audit before licensing, while Class B devices do.
3. Notified Body Audit: For Class B devices, an audit will be conducted within 90 days of application submission.
4. License Issuance: If all requirements are met, the MD-5 license will be issued within 20 days for Class B devices and 45 days for Class A devices.

The government fee for submitting the MD-03 application is ₹5,000 for registering the manufacturing site, plus an additional ₹500 for each device being registered.

The following documents are required:

1. Constitution details of the domestic manufacturer or authorized agent.
2. Site or plant master file.
3. Device master file.
4. Test license (for domestic manufacturers).
5. Compliance undertaking stating adherence to the Fifth Schedule.
6. Additional documents such as labels, product brochures, and Instructions for Use (IFU).
7. Performance evaluation report (for in vitro diagnostic devices).

cdscoregistration.com offers comprehensive support throughout the MD-5 licensing process, including:

• Guidance on QMS compliance.
• Dossier preparation and application submission.
• Audit coordination for Class B devices.
• Ongoing support for maintaining compliance and renewing licenses.

Compliance with MD-5 is essential for manufacturers to ensure that their medical devices meet safety, efficacy, and quality standards, allowing them to legally produce and distribute their products in the Indian market.

If you need assistance with the MD-5 registration process, you can contact us at cdscoregistration.com for expert guidance and support to simplify your medical device manufacturing registration.

The overall timeline for grant of MD-05 takes 4 to 6 months.

The Notified Body is responsible for conducting a comprehensive audit of the manufacturing site for Class B devices. Their assessment ensures that the facility complies with applicable standards and regulations. The audit report submitted by the Notified Body is critical for the State Licensing Authority’s decision-making.

The QMS is crucial for ensuring that manufacturing processes meet consistent quality standards. It encompasses practices and procedures that manufacturers must adhere to in order to maintain compliance with the Fifth Schedule and ensure the safety and efficacy of medical devices.

Manufacturers should:

• Review and ensure compliance with relevant standards and regulations.
• Maintain thorough documentation of their QMS and manufacturing processes.
• Conduct internal audits to identify and address potential non-conformities.
• Train staff on compliance requirements and audit procedures.

Yes, in vitro diagnostic medical devices require a performance evaluation report to be submitted with the application. This report must demonstrate the device's effectiveness and compliance with relevant standards.

To ensure your application is complete:

• Use a checklist of required documents, including constitutional details, master files, compliance undertakings, and performance evaluation reports.
• Confirm that all documents are properly signed and dated.
• Review the application thoroughly for accuracy and completeness.

Yes, manufacturers must continuously comply with regulatory requirements and maintain the QMS. This includes periodic audits, updating documentation, and renewing licenses as needed. Regular training for staff on compliance is also advisable.

Significant changes to the manufacturing process or device specifications may require re-evaluation and re-submission of documents to the State Licensing Authority. It's essential to consult with us before making changes.

cdscoregistration.com provides ongoing support for maintaining compliance, including:

• Regular updates on regulatory changes.
• Assistance with license renewals and re-evaluations.
• Training programs for staff on compliance and quality management.
• Audit preparation and support to ensure continued adherence to standards.