CDSCO License for Percussor.

Introduction to Percussor and Its Regulatory Importance in India

A Percussor is a small hammerlike device primarily used by physicians during neurological physical examinations to deliver light taps on specific body parts. This simple yet crucial diagnostic aid falls under the Class A (low risk) medical device category according to the CDSCO classification. Despite its straightforward design, regulatory compliance is essential to ensure safety, quality, and market access in India.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we understand the nuances involved in securing your Percussor manufacturing or import license efficiently. This guide outlines detailed steps, timelines, costs, and documentation specifically tailored for Percussors to help you enter the Indian market confidently.

CDSCO Regulatory Framework for Percussor (Class A Neurological Device)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Percussors, categorized as Class A devices under neurological devices, fall into the low-risk bracket. Consequently, the regulatory pathway involves obtaining a Manufacturing License (MD5) from the respective State Licensing Authority.

The regulatory framework mandates compliance with essential principles of safety and performance, adherence to quality management systems, and submission of technical documentation, including Device Master File (DMF) and Plant Master File (PMF).

Risk Classification and License Requirements for Percussor

As per the Medical Device Classification, Percussors are classified as Class A devices due to their non-invasive, low-risk nature. This classification determines the licensing pathway:

• Manufacturing License: MD5 (Application Form MD3) issued by the State Licensing Authority.
• Import License: MD15 (Application Form MD14), issued by the Central Licensing Authority.

Given Percussor’s Class A status, manufacturers must obtain the MD5 license before commercializing the device in India.

Manufacturing License Process (MD5) for Percussor

The MD5 license process for a Percussor involves several sequential steps:

1. Test License (Form MD13): Apply for a test license which allows you to manufacture the device for testing purposes. This phase typically takes 1.5 to 2 months.
2. Product Testing: Conduct product testing at government-approved laboratories to demonstrate compliance with applicable standards. Refer to the Testing Laboratories list for authorized labs.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, risk management files, and QMS documents.
4. Application Submission: Submit the MD5 license application using Form MD3 through the CDSCO MD Online Portal.
5. Notified Body Audit: Undergo an audit by a notified body. You can select from the list of notified bodies approved by CDSCO.
6. Queries and Clarifications: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon satisfactory review and audit, the MD5 manufacturing license for Percussor is granted.

Manufacturing License Documents Required for Percussor

To ensure a smooth approval process, manufacturers should assemble the following documents:

• Company Constitution (e.g., Memorandum of Association, Articles of Association)
• Proof of Ownership or Lease Agreement of the manufacturing premises
• Details and qualifications of technical staff involved in manufacturing
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing facility and quality systems (Plant Master File Guide)
• Essential Principles Checklist showing conformity to safety and performance standards
• Risk Management File illustrating hazard analysis and mitigation measures (Risk Management Guide)
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Percussor

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

1. Document preparation including proof of manufacturing license from the country of origin.
2. Submission of the application on Form MD14 via the CDSCO MD Online Portal.
3. Addressing queries from the CDSCO.
4. License grant.

Since Percussor is a Class A device, the MD15 license fees are relatively moderate. Note that unlike manufacturing licenses, test licenses are not required here.

Import License Documents Required for Percussor

The documentation for import licensing includes:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Here is an estimated timeline for a Percussor MD5 manufacturing license:

• Test License (MD13): 1.5 to 2 months
• Product Testing at Government Lab: 2 to 3 weeks
• Notified Body Audit: 3 to 4 weeks
• Application Review and Queries Resolution: 3 to 4 weeks
• Total Duration: Approximately 3 to 4 months

Import licenses (MD15) generally take around 5 to 6 months due to central authority review processes.

Government Fees and Costs

For Percussor as a Class A device, the fees are as follows:

• MD5 Manufacturing License Application Fee: Rs 5,000
• Per Product Fee: Rs 500

These fees are to be paid via the CDSCO portal during application. Additional costs may include:

• Notified Body audit fees (varies by body)
• Testing laboratory charges
• Consultant fees if you engage regulatory experts

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with essential principles.

Solution: Prepare a detailed checklist and ensure all documents such as Device Master File and Risk Management are complete. Our Device Master File guide and Risk Management guide can help streamline this.

Challenge: Difficulty coordinating with notified bodies or government testing labs.

Solution: Plan your audits and testing well in advance. Consult the list of notified bodies and testing laboratories early.

Challenge: Addressing technical queries from CDSCO inspectors.

Solution: Maintain open communication and respond promptly with supporting documents. Engage regulatory consultants with experience in CDSCO audits.

Expert Consultation and Support

With over two decades of experience guiding medical device manufacturers and importers, we offer comprehensive support for Percussor licensing:

• Gap analysis of your existing documentation
• End-to-end application preparation and submission
• Coordination with notified bodies and testing labs
• Mock audits and readiness assessments
• Timely resolution of CDSCO queries

Our expertise has helped 500+ companies successfully obtain licenses, saving them time and avoiding costly rejections.

Getting Started with Your CDSCO License Application for Percussor

Ready to enter the Indian market with your Percussor? Follow these practical steps:

1. Assess your product classification: Confirm Percussor as Class A and the appropriate licensing route.
2. Gather your documentation: Use our guides to prepare Device Master File and Plant Master File.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.
4. Plan for product testing: Schedule testing with a CDSCO-approved laboratory.
5. Select a notified body: Choose from the notified bodies list and schedule audit.
6. Prepare for audit and inspections: Conduct internal mock audits to ensure compliance.
7. Submit MD5 license application (Form MD3): After successful testing and audit.
8. Respond to any queries: Provide clarifications promptly.
9. Obtain your license: Begin manufacturing and marketing legally in India.

Navigating CDSCO licensing for Percussor can be complex, but with the right preparation and expert guidance, you can achieve compliance smoothly. Contact us today to leverage our extensive experience and ensure your success in the Indian medical device market.