CDSCO License for Gastroscope, General & Plastic Surgery

Introduction to Gastroscope Regulatory Compliance in India

Gastroscopes, primarily used in general and plastic surgery, are vital medical devices designed as flexible tubes equipped with a light and video camera to facilitate internal examination and tissue sampling. Given their critical role in diagnostics and surgical interventions, regulatory compliance for gastroscopes under the Central Drugs Standard Control Organisation (CDSCO) framework is paramount to ensure safety, efficacy, and quality in the Indian healthcare market.

With over 25 years of experience guiding more than 500 medical device manufacturers and importers, we understand the nuances of CDSCO licensing, especially for Class B devices like gastroscopes categorized under Dermatological & Plastic Surgery (Notification 29/Misc./03/2020-DC (147), dated 26.7.2021). This comprehensive guide walks you through the entire process, avoiding common pitfalls while providing practical, actionable insights.

CDSCO Regulatory Framework for Gastroscope (Class B Device)

Gastroscopes fall under Class B risk classification, meaning they have a low to moderate risk profile. Under the CDSCO medical device regulations, Class B devices require a manufacturing license known as the MD5 license, issued by the State Licensing Authority. This licensing scheme ensures that manufacturers comply with quality, safety, and performance standards before marketing their devices.

For importers, the MD15 import license issued by the Central Licensing Authority applies, ensuring imported gastroscopes meet Indian regulatory norms.

Risk Classification and License Requirements for Gastroscope

• Risk Class: B (Low to Moderate)
• License for Manufacturing: MD5 (Application Form MD3)
• Issuing Authority: State Licensing Authority
• License for Import: MD15 (Application Form MD14)
• Issuing Authority: Central Licensing Authority

Class B devices like the gastroscope require a test license (MD13) before the manufacturing license application, involving product testing in government-approved laboratories.

For detailed classification, visit our Medical Device Classification guide.

Manufacturing License Process for Gastroscope (MD5)

The MD5 manufacturing license process involves several crucial steps:

1. Test License Application (Form MD13): Initiate by applying for a test license, which authorizes limited production for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of the gastroscope in CDSCO-approved testing laboratories to validate compliance with Indian standards. Use the Testing Laboratories list to select authorized labs.

3. Document Preparation: Assemble all required documentation, including Device Master File (DMF), Plant Master File (PMF), and risk management files.

4. Application for MD5 License (Form MD3): Submit the comprehensive application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit of manufacturing premises and quality systems. Refer to the Notified Bodies list for available auditors.

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

7. Grant of MD5 License: Upon successful compliance, the license is granted on Form MD5, permitting full-scale manufacturing.

This end-to-end process usually takes around 3 to 4 months.

Manufacturing License Documents Required for Gastroscope

To facilitate a smooth application, ensure you have the following documents ready:

• Company Constitution: Incorporation certificate, partnership deed, or equivalent.
• Proof of Ownership or Lease of Manufacturing Premises: Legal ownership documents or lease agreements.
• Technical Staff Details: Qualification and experience certificates of technical personnel.
• Fire NOC and Pollution Control NOC: Certificates from relevant authorities.
• Device Master File (DMF): Detailed device design, manufacturing processes, and specifications. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of manufacturing facilities, equipment, and quality assurance systems. Learn more via our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist with Indian medical device standards.
• Risk Management File: Comprehensive risk analysis and mitigation strategies aligned with ISO 14971. For insights, visit our Risk Management guide.
• Test Reports: Certificates from CDSCO-approved laboratories demonstrating device safety and performance.
• Labels and Instructions for Use (IFU): Samples conforming to regulatory requirements.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related internal policies.

Import License Process for Gastroscope (MD15)

Importers of gastroscopes must secure an MD15 license from the Central Licensing Authority. The process includes:

1. Document Compilation: Gather manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate, DMF, PMF, company constitution, and wholesale license.

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

3. Departmental Review: The CDSCO evaluates the documentation and may raise queries.

4. Query Resolution: Promptly address any clarifications.

5. Grant of MD15 License: Upon approval, the import license is issued, enabling lawful importation.

The entire process generally takes 5 to 6 months.

Import License Documents Required for Gastroscope

• Valid Manufacturing License from the country of origin.
• Free Sale Certificate proving the device is legally sold in the origin country.
• ISO 13485:2016 Certificate verifying quality management.
• CE Certificate or equivalent certification.
• Device Master File and Plant Master File.
• Wholesale License for import distribution.
• Company Constitution and Address Proof.

Timeline and Processing Duration for Gastroscope Licensing

Being proactive with document readiness and prompt query responses can significantly reduce delays.

Government Fees and Costs for Gastroscope Licensing

• MD5 License (Class B):

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

• MD15 Import License:

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

Additional costs include testing laboratory charges (varies by lab and test scope) and notified body audit fees, which typically range between INR 50,000 to INR 1,50,000 depending on audit complexity.

Common Challenges and Practical Solutions

• Delays in Testing: Selecting government-approved labs early and scheduling tests promptly can prevent bottlenecks.
• Incomplete Documentation: Use checklists and expert validation to ensure completeness before submission.
• Audit Non-compliance: Prepare thoroughly with mock audits and corrective action plans.
• Query Resolution Delays: Establish a dedicated regulatory liaison for timely responses.

Our experience shows that manufacturers who engage with notified bodies early and maintain transparent communication with CDSCO authorities navigate the process more efficiently.

Expert Consultation and Support for Gastroscope Licensing

Navigating the CDSCO regulatory landscape requires expertise. We offer end-to-end consulting, including:

• Gap analysis and readiness assessment
• Document preparation and review
• Coordination with notified bodies and testing labs
• Application filing and follow-up
• Training on post-market surveillance and compliance

Our track record of successfully obtaining licenses for over 500 medical devices reflects our commitment to your regulatory success.

Getting Started with Your CDSCO License Application for Gastroscope

1. Assess Device Classification: Confirm your gastroscope’s Class B status via official CDSCO guidelines.
2. Compile Preliminary Documentation: Begin assembling your DMF, PMF, QMS certifications, and company legal documents.
3. Apply for Test License (MD13): Submit your initial test license application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Engage with CDSCO-approved laboratories early to align testing timelines.
5. Prepare for Audit: Coordinate with a notified body for the mandatory audit; schedule it in parallel with document finalization.
6. Submit MD5 Application: Once test reports and audit readiness are confirmed, apply for the manufacturing license on Form MD3.
7. Monitor Application Status: Regularly track your application through the CDSCO portal and address any queries immediately.

Embarking on your CDSCO licensing journey for the gastroscope with informed preparation and expert guidance ensures timely market entry and regulatory compliance. Reach out to our team to leverage our 25+ years of consultancy experience and make your regulatory process seamless and efficient.