CDSCO License for Anoscope, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Anoscopes (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing process, we understand the intricacies involved in obtaining approval for medical devices like the reusable anoscope. This device, classified as Class B under Indian regulations, is pivotal in gastroenterology for the visual examination and treatment of the anus and rectum. Navigating the regulatory framework efficiently ensures timely market entry and compliance with Indian laws.

Understanding the CDSCO Regulatory Framework for Reusable Anoscopes

The Central Drugs Standard Control Organization (CDSCO) governs medical device approval in India under the Medical Device Rules, 2017. The reusable anoscope falls under Class B - low to moderate risk category devices. As per notification 29/Misc./03/2020-DC (182) dated 27.09.2021, this device requires a manufacturing license under form MD5 issued by the State Licensing Authority.

Risk Classification and License Requirements for Anoscopes

• Device: Reusable Anoscope
• Risk Class: B (Low to moderate risk)
• Regulatory Form: MD5 Manufacturing License (Application Form MD3)
• Authority: State Licensing Authority

Class B devices require a thorough but streamlined approval process involving:

• Obtaining a Test License (MD13)
• Product testing at CDSCO-approved labs
• Notified body audit
• Submission of comprehensive documentation

For detailed risk classification, refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Reusable Anoscopes

The entire MD5 license process typically takes 3 to 4 months and involves the following sequential steps:

1. Test License (Form MD13): Apply for and obtain a test license to manufacture the reusable anoscope for testing purposes. This stage takes about 1.5 to 2 months.

2. Product Testing: Send samples for evaluation at CDSCO-recognized laboratories. You can find the list of authorized labs on the CDSCO Testing Laboratories page.

3. Documentation Preparation: Compile all necessary technical and quality documents.

4. Application Submission (Form MD3): Submit your MD5 license application through the CDSCO MD Online Portal, along with all supporting documents.

5. Audit by Notified Body: A notified body will conduct a facility audit. Check the current list of notified bodies authorized for such audits.

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

7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license for the reusable anoscope is granted.

Manufacturing License Documents Required for MD5

To ensure a smooth review process, the following documents must be prepared meticulously:

• Company Constitution Document: Proof of legal entity such as incorporation certificate.
• Proof of Ownership or Lease of Manufacturing Premises: Valid legal documents.
• Technical Staff Qualification Details: CVs and qualifications of key personnel.
• Fire NOC and Pollution Control NOC: From respective authorities.
• Device Master File (DMF): Detailed design, manufacturing, and quality information. Our Device Master File guide can help you prepare this.
• Plant Master File (PMF): Description of your manufacturing facility. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance checklist with medical device standards.
• Risk Management File: Documented risk analysis and mitigation strategies. Learn more about risk management for medical devices.
• Test Reports: From CDSCO-approved labs.
• Labels and Instructions for Use (IFU): Drafts showing compliance with Indian regulations.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures.

Import License Process (MD15) for Reusable Anoscopes

If you plan to import reusable anoscopes into India, an Import License (Form MD15) issued by the Central Licensing Authority is mandatory. The process is slightly different:

• No Test License required.
• Complete document preparation including manufacturing license from country of origin, Free Sale Certificate, CE certificate (if applicable), ISO 13485:2016, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Application submission through the CDSCO MD Online Portal.
• Queries resolution phase.
• License grant within 5 to 6 months.

Refer to our detailed Import License Guide for comprehensive insights.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution
• Company Constitution and address proof

Timeline and Processing Duration Summary

Government Fees and Costs

• MD5 Manufacturing License Fees:

  • Rs. 5,000 per application
  • Rs. 500 per product

• Additional costs include testing fees at government-approved labs and notified body audit fees (varies by auditor).

Common Challenges and Practical Solutions

• Delay in Test License Approval: Begin the MD13 application early and ensure all documents are error-free.
• Non-compliance in Documentation: Engage experienced consultants to create DMF, PMF, and risk files aligned with CDSCO expectations.
• Audit Non-conformities: Conduct internal audits and gap analyses before notified body audit.
• Query Response Delays: Assign dedicated resources for prompt and thorough responses.

Expert Consultation and Support

Our expertise in navigating CDSCO regulations ensures your reusable anoscope license applications are prepared with precision. We provide:

• Detailed gap analysis of your documentation
• Assistance in preparing Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Training on regulatory compliance and QMS implementation

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to initiate your Test License (MD13) application.
2. Compile your device and plant master files using our comprehensive guides.
3. Schedule product testing at approved laboratories early to avoid bottlenecks.
4. Engage a notified body from the official list to plan your audit.
5. Prepare all statutory documents including licenses, NOCs, and certifications.
6. Submit your MD5 license application (Form MD3) and track progress regularly.

By following these actionable steps and leveraging our extensive experience, manufacturers and importers can efficiently obtain CDSCO approval for reusable anoscopes and gain a competitive edge in the Indian gastroenterology device market.