CDSCO License for Perineal warmer

Comprehensive Guide to CDSCO Licensing for Perineal Warmers (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in navigating India's medical device regulations, we understand the nuances involved in obtaining CDSCO licenses. This guide focuses specifically on Perineal Warmers — a Class B obstetrical and gynecological device intended for pain relief in the vulva post-episiotomy. Our goal is to provide you with detailed, actionable insights into the regulatory framework, timelines, costs, and documentation for obtaining your manufacturing or import license in India efficiently.

Understanding Perineal Warmers and Their Regulatory Importance

Perineal warmers play a vital role in postpartum care by alleviating pain and promoting healing after episiotomies. Given their direct interaction with body tissues and sensitive applications, these devices fall under Class B risk category as per CDSCO’s classification. This classification dictates the regulatory pathway, including mandatory testing, audits, and documentation to ensure safety and efficacy before market entry.

CDSCO Regulatory Framework for Perineal Warmers (Class B Devices)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. For Class B devices like Perineal Warmers, the manufacturing license is granted by the State Licensing Authority via the MD5 license process, which ensures compliance through rigorous testing and audits.

Manufacturers must first obtain a Test License (Form MD13) to conduct product testing, followed by submission of a comprehensive manufacturing license application (Form MD3). All applications are submitted online through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Perineal Warmers

• Risk Class: B (Low-Moderate risk)
• License Type: Manufacturing License - MD5
• Issuing Authority: State Licensing Authority
• Applicable Forms: MD13 (Test License), MD3 (Manufacturing License Application), MD5 (License Grant)

For importers, the process involves obtaining an MD15 import license from the Central Licensing Authority, which has different documentation and timelines.

Manufacturing License Process for Perineal Warmers (MD5)

1. Apply for Test License (MD13): Submit product samples for mandatory testing at government-approved labs (Approved Testing Laboratories) after obtaining a test license. This process typically takes 1.5 to 2 months.

2. Product Testing: Testing ensures compliance with Indian standards and safety requirements.

3. Prepare Documents: Compile all technical files, including Device Master File and Plant Master File, risk management documentation, and quality management system evidence.

4. Submit Manufacturing License Application (MD3): Upload complete documentation via the CDSCO portal.

5. Audit by Notified Body: A designated notified body conducts on-site audits to verify compliance. You can consult the List of Notified Bodies authorized for Class B devices.

6. Queries and Clarifications: Address any queries raised by CDSCO or the notified body promptly to avoid delays.

7. Grant of License (MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Perineal Warmers

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board Clearance
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File describing manufacturing site and quality controls (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with MDR
• Risk Management File specific to Perineal Warmers (Risk Management Guide)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (e.g., ISO 13485:2016 certifications)

Import License Process for Perineal Warmers (MD15)

For importers wanting to bring Perineal Warmers into India, the MD15 import license is issued by CDSCO’s Central Licensing Authority. The process includes:

• Document preparation including manufacturing license from the country of origin, free sale certificate, ISO 13485 certificate, CE marking (if applicable), Device Master File, Plant Master File, wholesale drug license, and company constitution.

• Submitting the application online via the CDSCO portal.

• Responding to any departmental queries.

• License issuance usually takes 5-6 months.

For detailed guidance on import licensing, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for Distribution in India
• Company Constitution

Timeline and Processing Duration

The entire process for manufacturing Perineal Warmers may take approximately 4 to 6 months from test license application to final manufacturing license grant.

Government Fees and Costs

• MD5 Manufacturing License (Class B):

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• Test License (MD13): No separate fee specified, but testing costs at government-approved labs vary based on product complexity.

• Import License (MD15):

  • Site Fee for Class B: $2,000
  • Per Product Fee for Class B: $1,000

Ensure timely payment of fees through the CDSCO MD Online Portal to avoid processing delays.

Common Challenges and Solutions

Challenge: Delays in product testing due to sample non-compliance or incomplete test license applications.

Solution: Engage early with notified testing labs listed on the CDSCO portal and meticulously complete the MD13 application with all supporting documents.

Challenge: Non-conformity during notified body audits causing repeated inspections.

Solution: Prepare thoroughly with internal mock audits and ensure your Quality Management System aligns with ISO 13485 standards.

Challenge: Responding to CDSCO queries can be time-consuming.

Solution: Assign dedicated regulatory personnel or engage expert consultants to provide timely and compliant responses.

Expert Consultation and Support

With over 25 years of industry experience, we have supported over 500 companies in successfully obtaining CDSCO licenses for devices like Perineal Warmers. Our hands-on approach includes:

• Gap analysis and document preparation
• Liaising with notified bodies and testing laboratories
• Audit readiness and mock inspections
• Timely query management and follow-ups

Contact us to leverage our expertise and streamline your CDSCO licensing journey.

Getting Started with Your CDSCO License Application for Perineal Warmers

1. Evaluate Your Device Class: Confirm that Perineal Warmers are Class B and require MD5 licensing.

2. Register on the CDSCO MD Online Portal: This is mandatory for all submissions.

3. Apply for Test License (MD13): Prepare samples and submit your application for testing.

4. Engage a Notified Body: Use the List of Notified Bodies to select a qualified auditor.

5. Prepare Documentation: Compile all technical files and quality system documents thoroughly.

6. Submit Manufacturing License Application (MD3): Upload your complete dossier and await audit scheduling.

7. Respond to Queries Promptly: Ensure swift resolution of any regulatory questions.

8. Receive License (MD5): Begin manufacturing and marketing your Perineal Warmers legally in India.

Embarking on your CDSCO licensing process with clear guidance and expert support ensures compliance, reduces delays, and accelerates your time-to-market. Reach out to us for tailored assistance at every step.

For more detailed information on specific documents, testing protocols, and audit preparations, explore our comprehensive guides on MD5 Licensing and Risk Management.

We look forward to partnering with you on your regulatory journey for Perineal Warmers in India.