CDSCO License for Gastrointestinal endoscopic clip applier

Comprehensive Guide to CDSCO Licensing for Gastrointestinal Endoscopic Clip Applier (Class B Device)

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in navigating the CDSCO licensing maze, we understand the complexities involved in bringing specialized medical devices like the Gastrointestinal Endoscopic Clip Applier to the Indian market. This device, classified as a Class B medical device under CDSCO regulations, plays a critical role in endoscopic procedures including haemostasis, tissue approximation, and closure of GI tract perforations.

CDSCO Regulatory Framework for Gastrointestinal Endoscopic Clip Applier

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Since the notification dated 27.09.2021 (Notification No. 29/Misc./03/2020-DC (182)), the Gastrointestinal Endoscopic Clip Applier has been explicitly included under Class B devices in the gastroenterology category. This classification mandates compliance with the regulatory framework defined for medium-risk devices.

Manufacturers must follow the MD5 license process for manufacturing within India, administered by the respective State Licensing Authority. For imports, the MD15 import license issued by the Central Licensing Authority is applicable.

Risk Classification and License Requirements

The Gastrointestinal Endoscopic Clip Applier is classified as a Class B medical device, indicating moderate risk. This classification requires obtaining an MD5 manufacturing license (Form MD3) for domestic manufacturing and an MD15 import license (Form MD14) for importers.

• Class B (Medium Risk): Licensed by State Authority for manufacturing.
• License Type: MD5 Manufacturing License
• Test License: Mandatory MD13 Test License before MD5

For detailed classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Device

The entire licensing process typically spans 3 to 4 months and involves multiple key steps:

1. Apply for Test License (Form MD13): This prerequisite license enables product testing and takes approximately 1.5 to 2 months.
2. Product Testing: Conduct required testing at CDSCO-approved labs. Refer to the Testing Laboratories list to select an authorized facility.
3. Document Preparation: Prepare comprehensive documents including the Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Submit Manufacturing License Application (Form MD3): Apply via the CDSCO MD Online Portal.
5. Audit by Notified Body: Your manufacturing site will be audited by a notified body certified for Class B devices. Check the Notified Bodies list for eligible auditors.
6. Address Queries: Respond promptly to any queries raised by CDSCO or the notified body.
7. License Grant (Form MD5): Upon successful compliance, the manufacturing license is issued.

Manufacturing License Documents Required

For your Gastrointestinal Endoscopic Clip Applier, prepare the following documents meticulously:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details of Qualified Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, manufacturing process, and validation (see our Device Master File guide)
• Plant Master File (PMF): Manufacturing facility layout, equipment, and quality measures (refer to our Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian medical device standards
• Risk Management File demonstrating compliance with ISO 14971 principles (Risk Management guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15)

If you are an importer aiming to bring the Gastrointestinal Endoscopic Clip Applier into India, you will need an MD15 import license issued by the Central Licensing Authority. The process generally takes 5 to 6 months.

Key steps include:

1. Document Preparation: Gather manufacturing license from country of origin, Free Sale Certificate, CE certificate, ISO 13485:2016, Device and Plant Master Files, Wholesale license, and company constitution.
2. Apply for License (Form MD14) via the CDSCO MD Online Portal.
3. Respond to Queries: Address any clarifications raised by CDSCO.
4. License Issuance (Form MD15)

Full details on the MD15 process are available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate authorized by the exporting country
• CE Certificate or equivalent regulatory approval
• ISO 13485:2016 certification
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Registration Proof

Timeline and Processing Duration

Government Fees and Costs

For a Class B device such as the Gastrointestinal Endoscopic Clip Applier:

• MD5 Manufacturing License
  • Application Fee: ₹5,000
  • Per Product Fee: ₹500
• MD15 Import License
  • Site Fee: $2,000 (approx ₹1.5 lakh)
  • Per Product Fee: $1,000 (approx ₹75,000)

Note that additional costs include testing fees at government-approved labs, audit fees charged by notified bodies, and consultancy fees if applicable.

Common Challenges and Solutions

• Delays in Test License Approval: To avoid bottlenecks, submit a complete and accurate MD13 application with all required documents. Early engagement with testing labs can expedite this phase.

• Document Gaps: Missing or incomplete Device Master File or Risk Management File is a frequent cause of queries. Utilize our detailed guides to ensure thorough documentation.

• Audit Non-Compliance: Prepare your facility well in advance for notified body audits. Conduct internal mock audits to identify and rectify gaps.

• Query Resolution Delays: Assign a dedicated regulatory contact to promptly respond to CDSCO queries to avoid unnecessary delays.

Expert Consultation and Support

With over 25 years of specialized experience, we provide end-to-end support for CDSCO licensing for gastroenterology devices like the Gastrointestinal Endoscopic Clip Applier. Our proven track record includes successful MD5 and MD15 license applications, audit preparation, document compilation, and regulatory strategy.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status using the official CDSCO guidelines.
2. Initiate Test License Application (MD13): Begin early to accommodate testing timeframes.
3. Engage a CDSCO-Approved Testing Laboratory: Select from the official testing labs list.
4. Compile Complete Documentation: Use our Device and Plant Master File guides to prepare robust files.
5. Schedule Notified Body Audit: Identify and book an audit well ahead of your license application submission.
6. Submit Application via CDSCO MD Online Portal: Utilize the streamlined digital process for application and follow-up.

By adhering to these practical steps and leveraging expert guidance, manufacturers and importers of Gastrointestinal Endoscopic Clip Appliers can successfully navigate CDSCO requirements and accelerate market entry in India.

For further personalized assistance and detailed licensing support, feel free to contact us.