CDSCO License for Percussion hammer, manual

Comprehensive Guide to CDSCO Licensing for Percussion Hammer (Manual) – Class A Neurological Device

Manufacturers and importers of the percussion hammer, a manual neurological device used by physicians to test reflexes, must navigate the regulatory framework of the Central Drugs Standard Control Organization (CDSCO) to legally market their product in India. With over 25 years of experience supporting 500+ companies, we provide you with a precise roadmap to secure your CDSCO manufacturing or import license efficiently.

Understanding Percussion Hammer and Its Regulatory Importance

The percussion hammer is a Class A medical device under CDSCO’s risk classification system, indicating a low-risk device. Despite its simplicity, regulatory compliance is crucial to ensure safety, efficacy, and quality. The device is covered under Notification 29/Misc/03/2020-DC (201) dated 27.09.2021, which governs neurological diagnostic tools.

CDSCO Regulatory Framework for Percussion Hammer (Manual)

Class A devices fall under the State Licensing Authority's jurisdiction for manufacturing licenses, governed by the MD5 license process. Importers must secure the MD15 license from the Central Licensing Authority. The regulatory framework ensures that all devices meet quality benchmarks through testing, documentation, and audits.

Risk Classification and License Requirements for Percussion Hammer

• Risk Class: A (Low risk)
• Applicable License: MD5 Manufacturing License for local manufacturers
• License Authority: State Licensing Authority
• Testing and Audit: Mandatory testing from government-approved labs and audit by a notified body
• Application Portal: CDSCO MD Online Portal

Detailed Manufacturing License Process (MD5) for Percussion Hammer

1. Obtain Test License (Form MD13): Before applying for manufacturing license, apply for a test license which typically takes 1.5 to 2 months for approval.
2. Product Testing: Submit the percussion hammer samples to government-approved testing laboratories. Approved labs can be found on the Testing Laboratories list.
3. Document Preparation: Prepare comprehensive documentation including Device Master File and Plant Master File.
4. Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body conducts an on-site audit; refer to the Notified Bodies List to select an authorized auditor.
6. Respond to Queries: Address any observations or queries raised during audit or by the CDSCO.
7. Grant of License (Form MD5): Upon successful audit and document verification, the license is issued.

Manufacturing License Documents Required for Percussion Hammer

• Company Constitution (Incorporation certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – including specs, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – detailing manufacturing facilities and quality control (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Product Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Percussion Hammer

If you are an importer, the MD15 license from the Central Licensing Authority is required.

• No test license required but you must provide certificates such as Free Sale Certificate, CE Certificate, and ISO 13485:2016.
• Submit application on the CDSCO MD Online Portal.
• Process duration is approximately 5-6 months.
• Respond promptly to any departmental queries.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution and Authorized Signatory details

Timeline and Processing Duration

Import license (MD15) typically requires 5 to 6 months due to central processing and additional documentation verification.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Included in the manufacturing license process
• Audit and Testing Costs: Variable; testing laboratories may charge separately (approx Rs. 30,000 - Rs. 50,000 depending on complexity)

For import license (MD15), fees vary by risk class and product quantity.

Common Challenges and Solutions

• Delayed Test Reports: Coordinate closely with approved labs to prioritize testing; consider multiple labs to avoid bottlenecks.
• Incomplete Documentation: Use comprehensive checklists and consult expert guides like our MD5 License Guide to ensure all files are accurate.
• Audit Non-compliance: Pre-audit internal checks and mock audits can help prepare for notified body inspections.
• Query Resolution Delays: Maintain a dedicated regulatory contact to respond promptly to CDSCO communications.

Expert Consultation and Support

Navigating the CDSCO licensing for your percussion hammer can be complex. Our expert team has successfully guided 500+ companies through this process, ensuring timely approvals and compliance. We offer tailored regulatory consulting, document preparation, and liaison with notified bodies and CDSCO officials.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device's risk class as Class A using Medical Device Classification.
2. Gather Documentation: Begin compiling all mandatory documents including technical and quality files.
3. Apply for Test License on the CDSCO MD Online Portal: Initiate the application via the CDSCO MD Online Portal.
4. Engage a Notified Body: Select an accredited notified body early to schedule audits.
5. Plan Testing Schedule: Coordinate with approved laboratories for sample testing.
6. Prepare for Audit: Conduct internal quality and compliance audits ahead of the official inspection.

Taking these practical steps will streamline your pathway to obtaining the MD5 manufacturing license for your percussion hammer, enabling you to confidently enter the Indian market.

For personalized assistance, feel free to reach out to our regulatory experts who can provide end-to-end support tailored to your specific needs.