CDSCO License for Birthing bed/table, powered

Introduction: Understanding Powered Birthing Beds and Their Regulatory Importance

Powered birthing beds, also known as birthing tables, play a crucial role in obstetrical and gynecological care by providing ergonomic support during labor and delivery. As Class A medical devices under the CDSCO classification, these beds are considered low-risk but still require strict compliance with regulatory norms to ensure patient safety and device efficacy. Navigating the CDSCO licensing process for such devices can be complex without expert guidance, especially given the specific documentation, testing, and audit requirements.

With over 25 years of experience and having assisted 500+ companies in securing CDSCO approvals, we understand the unique challenges manufacturers and importers face. This comprehensive guide details everything you need to know about obtaining the MD5 manufacturing license for powered birthing beds in India.

CDSCO Regulatory Framework for Powered Birthing Beds

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, classifying devices based on risk and intended use. Powered birthing beds are categorized under obstetrical and gynecological devices, notified specifically under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022.

As a Class A device, it falls under the purview of the State Licensing Authority for manufacturing licenses. The regulatory framework mandates compliance with quality management systems, product testing, and conformity to essential principles to ensure safety.

Risk Classification and License Requirements for Birthing Beds

Powered birthing beds are classified as Class A devices, representing the lowest risk category. This classification requires manufacturers to obtain the MD5 manufacturing license (Application Form MD3) issued by the State Licensing Authority.

Key requirements include:

• Obtaining a test license (Form MD13) before manufacturing
• Product testing at government-approved laboratories
• Submission of comprehensive documentation including Device Master File and Plant Master File
• Audit by a notified body listed on the CDSCO website

Manufacturing License Process (MD5) for Powered Birthing Beds

The manufacturing license process for Class A devices like powered birthing beds typically spans 3 to 4 months and includes the following steps:

1. Test License Application (Form MD13): Submit an application for a test license to manufacture samples for testing. This process takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing of the device at CDSCO-approved labs, such as those listed here.
3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. Manufacturing License Application (Form MD3): Submit the application for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an on-site audit by a notified body to verify compliance.
6. Resolution of Queries: Address any observations or queries raised by the department or notified body.
7. Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required

For powered birthing beds, the document checklist includes:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Documents
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities and quality systems (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with CDSCO requirements
• Risk Management File outlining hazard analysis and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Powered Birthing Beds

For importers, the MD15 import license is mandatory before introducing powered birthing beds into the Indian market. This license is issued by the Central Licensing Authority and generally takes 5 to 6 months.

Key steps include:

• Preparing complete import documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO and CE certificates
• Submitting the application on the CDSCO MD Online Portal
• Responding to queries during the evaluation process

Unlike manufacturing licenses, a test license is not required for import applications.

Import License Documents Required

Import license applications for powered birthing beds require:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate demonstrating compliance with international standards
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

For import licenses (MD15), expect a total duration of 5 to 6 months.

Government Fees and Costs

The fee structure for Class A powered birthing beds is as follows:

• Test License (MD13): Included in overall fees
• Manufacturing License (MD5): Rs 5,000 per application plus Rs 500 per product

Note: Additional costs include fees for product testing at government-approved laboratories and notified body audit charges, which can vary.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-select government-approved labs and schedule testing early. Maintain clear communication with labs to expedite reports.

Challenge 2: Documentation Gaps

• Solution: Use comprehensive templates for Device Master File and Plant Master File. Regularly update risk management and QMS documents.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal mock audits before notified body visits. Ensure facility readiness and staff training.

Challenge 4: Query Resolution Delays

• Solution: Prepare detailed, evidence-backed responses promptly. Engage regulatory consultants for expert handling.

Expert Consultation and Support

Navigating CDSCO licensing for powered birthing beds requires specialized knowledge of regulatory nuances, document preparation, and procedural compliance. Our seasoned team, with a track record of supporting 500+ clients, provides end-to-end assistance—from test license application to post-audit follow-up.

We also offer tailored training for your technical and regulatory teams, ensuring smoother audits and faster approvals. Leveraging our expertise can significantly reduce approval timelines and mitigate risks of non-compliance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification & Eligibility: Confirm your powered birthing bed falls under Class A as per the latest CDSCO notification.
2. Prepare Preliminary Documentation: Begin compiling your company constitution, ownership proofs, and technical staff credentials.
3. Apply for Test License (Form MD13): Submit your application via the CDSCO MD Online Portal. Early submission accelerates downstream processes.
4. Coordinate Product Testing: Engage with CDSCO-approved labs promptly to schedule testing.
5. Organize Device and Plant Master Files: Utilize our detailed Device Master File guide and Plant Master File guide to ensure completeness.
6. Plan for Notified Body Audit: Review the list of notified bodies and schedule audits accordingly.
7. Submit Manufacturing License Application (Form MD3): Once testing and documentation are complete, apply online.

Our dedicated team is ready to support you at every step, ensuring a seamless journey towards CDSCO MD5 licensing for your powered birthing beds. Reach out today to start your application process with confidence.