CDSCO License for Protein supplement for in vitro embryo culture

Introduction to Protein Supplement for In Vitro Embryo Culture and Regulatory Importance

Protein supplements like Human Serum Albumin (HSA), Synthetic Serum Substitute (SSS), and Dextran Serum Supplement (DSS) play a critical role in assisted reproductive procedures by supporting gamete and embryo culture media. Classified under the Obstetrical and Gynecological category and notified by CDSCO under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, these supplements are essential but carry a moderate risk profile (Class B). Regulatory compliance for such devices is vital to ensure safety, efficacy, and market entry in India. As experienced consultants who have assisted over 500 companies, we understand the nuances of navigating the CDSCO licensing process for this specialized product.

CDSCO Regulatory Framework for Protein Supplements in Assisted Reproduction

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India under the Medical Device Rules (2017). Protein supplements for in vitro embryo culture fall under Class B, indicating a low to moderate risk. The regulatory framework mandates obtaining a manufacturing license (MD5 license) from the respective State Licensing Authority before commercialization.

Risk Classification and License Requirements

• Device Risk Class: B (Low Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority
• Process Includes: Test License (MD13), Product Testing, Notified Body Audit, License Grant

For detailed classification and risk management guidance, you can refer to our Medical Device Classification and Risk Management guides.

Manufacturing License Process for Class B Devices (MD5 License)

Successful entry into the Indian market for your protein supplement involves several sequential steps:

1. Apply for Test License (Form MD13): Required to conduct product testing in government-approved labs.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with notified standards.
3. Document Preparation: Compile necessary documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.
4. Filing Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Notified Body Audit: Arrange for a quality system audit by a notified body authorized for MD5 licenses. The list of Notified Bodies can be referenced for selection.
6. Respond to Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon satisfactory compliance and audit, the MD5 manufacturing license will be granted.

Manufacturing License Documents Required

To ensure a smooth application process for your protein supplement, the following documents must be meticulously prepared and submitted:

• Company Constitution Documents: Certificate of Incorporation, Memorandum and Articles of Association
• Proof of Ownership or Lease of Premises: Registered lease agreement or ownership documents
• Technical Staff Details: Qualification and experience certificates of technical personnel involved in manufacturing
• Fire NOC and Pollution Control NOC: From local authorities
• Device Master File (DMF): Detailed product specifications, formulation, manufacturing process, and controls (Reference Guide)
• Plant Master File (PMF): Manufacturing facility details, equipment, environment control (Guide)
• Essential Principles Checklist: Demonstrating compliance with CDSCO notified standards
• Risk Management File: Addressing identified risks and mitigation strategies
• Test Reports from Approved Labs: Confirming product safety and performance
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
• Quality Management System Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15 License) for Protein Supplements

If you plan to import protein supplements into India, an MD15 import license must be obtained from the Central Licensing Authority. The process includes:

• Preparation of comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and product-specific master files.
• Application submission via the CDSCO MD Online Portal.
• Review and queries resolution by CDSCO.
• Grant of MD15 License typically within 5-6 months.

For detailed guidance, our Import License Guide provides step-by-step insights.

Import License Documents Required

• Valid Manufacturing License of the exporter
• Free Sale Certificate issued by the competent authority
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution documents

Timeline and Processing Duration

Note: Timelines may vary depending on document completeness and audit scheduling.

Government Fees and Costs

• Test License (MD13): Nominal fees as per CDSCO norms
• MD5 Application Fee: Rs 5,000 per application
• Per Product Fee: Rs 500 per product
• Audit and Testing Fees: Variable based on notified body and testing laboratory charges

Budgeting for these fees upfront ensures smooth financial planning.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants underestimate the detail required in Device and Plant Master Files. We recommend using our detailed guides and checklists to avoid delays.
• Audit Non-Compliance: Lack of preparedness for notified body audits is a common hurdle. Conduct internal mock audits and train your quality team thoroughly.
• Delayed Testing: Coordinate with approved testing laboratories early to schedule testing slots and avoid bottlenecks.
• Regulatory Queries: Timely and clear responses to CDSCO queries significantly shorten approval times.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO license acquisitions, we provide end-to-end support:

• Gap analysis and document preparation
• Liaison with notified bodies and CDSCO officials
• Training for compliance and audit readiness
• Strategic planning for timeline optimization

Our proven approach helps manufacturers of protein supplements and other Class B devices achieve regulatory approval efficiently.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your product’s risk class as Class B.
2. Prepare Your Master Files: Start compiling your Device Master File and Plant Master File using our practical guides.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Schedule testing with government-approved labs early.
5. Plan for Audit: Identify and engage a notified body from the official Notified Bodies List.
6. Submit Manufacturing License Application (MD3): Once testing is complete, file your MD5 application.

Taking these actionable steps with expert support will streamline your path to market entry. Contact us today to kick-start your CDSCO licensing journey for protein supplements used in assisted reproductive technologies.