CDSCO License for Birthing bath

Comprehensive Guide to CDSCO Licensing for Birthing Bath (Class A Medical Device)

Birthing baths serve a critical role in pediatrics and neonatology by providing a warm, soothing environment for mothers before and during childbirth. Designed to support natural birthing processes, these devices are typically large baths filled with heated water and may include diagnostic attachments or connectors. Given their direct impact on maternal and neonatal health, regulatory compliance is paramount. As seasoned consultants with over 25 years of experience and having supported 500+ companies in CDSCO licensing, we present a tailored roadmap for obtaining the CDSCO manufacturing license (MD5) for your Class A Birthing Bath.

CDSCO Regulatory Framework for Birthing Baths

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Birthing baths fall under the Class A category, which are low-risk devices. The regulation ensures that devices meet essential safety and performance standards before they reach healthcare providers and patients.

Your device’s regulatory approval is based on the File No. 29/MiscJ03/2020-DC (150), notified on 23rd August 2021, affirming its classification and compliance requirements.

Risk Classification and License Requirements

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (issued by State Licensing Authority)
• Application Form: MD3

Class A devices require compliance with basic safety standards, quality management systems, and audit by a notified body. This class benefits from a relatively streamlined approval process compared to higher-risk devices.

For a detailed understanding of device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Birthing Baths

The MD5 license process involves several well-defined steps:

1. Test License (Form MD13): Begin by applying for a test license, allowing limited manufacture for testing purposes. This step typically takes 1.5 to 2 months.

2. Product Testing: Obtain product testing from government-approved laboratories. Testing is mandatory to demonstrate compliance with essential principles.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Quality Management System documents, and labels.

4. License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: Your manufacturing site will undergo an audit by a government-recognized notified body to verify compliance.

6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory review and audit, the license is granted.

The entire process typically spans 3 to 4 months.

For a step-by-step walkthrough, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required

Successful MD5 applications require the following documentation:

• Company Constitution Documents (e.g., Incorporation Certificate, Partnership Deed)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Technical Staff Qualification Details (e.g., Engineers, Quality Managers)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Comprehensive details on device design, components, and manufacturing processes. Our Device Master File guide clarifies this requirement.
• Plant Master File (PMF): Details on manufacturing facilities and quality controls. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrates compliance with safety and performance standards.
• Risk Management File: Risk assessment and mitigation strategies aligned with ISO 14971 are expected. Check our Risk Management guide.
• Product Test Reports from government-approved labs. See the list of Testing Laboratories.
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents reflecting ISO 13485 or equivalent practices

Import License Process (MD15) for Birthing Baths

For companies importing birthing baths into India, an MD15 Import License issued by the Central Licensing Authority is mandatory.

Key steps include:

1. Document Preparation: Assemble key documents including existing manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), DMF, PMF, wholesale license, and company constitution.

2. Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Promptly address any CDSCO queries.

4. License Grant: Typically within 5 to 6 months.

Fees vary by risk class and product count.

For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration

Total Estimated Time: 3 to 4 months for MD5 Manufacturing License.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product
• Testing Costs: Variable depending on lab and tests; typically ₹50,000 - ₹1,00,000
• Audit Fees: Paid directly to notified bodies; consult the List of Notified Bodies for guidance.

Budgeting for these costs upfront will avoid delays.

Common Challenges and Solutions

• Delayed Test Reports: Engage government-approved labs early to schedule testing.
• Incomplete Documentation: Use comprehensive checklists; our Device and Plant Master File guides are invaluable.
• Audit Non-Compliance: Pre-audit internal checks and quality system training reduce risk.
• Query Delays: Assign a dedicated compliance officer to respond promptly.

Our extensive experience enables us to foresee and mitigate these issues efficiently.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. We offer end-to-end consultancy, including:

• Regulatory strategy and classification
• Document preparation and gap analysis
• Coordination with notified bodies and labs
• Application submission and follow-up
• Audit readiness and training

Partnering with experts accelerates your time-to-market and ensures compliance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your birthing bath is Class A.
2. Enroll on CDSCO MD Online Portal: Register your organization here.
3. Prepare Test License Application: Submit Form MD13 to initiate manufacturing for testing.
4. Schedule Product Testing: Contact government-approved labs early.
5. Compile Documentation: Use our Device and Plant Master File templates.
6. Engage a Notified Body: Book audits in advance.
7. Submit Manufacturing License Application: Apply using Form MD3.

By following this structured approach, manufacturers and importers can confidently navigate CDSCO requirements for birthing baths, ensuring a smooth path to regulatory approval and successful market entry in India.