CDSCO License for Flexible video duodenoscope, reusable

Comprehensive Guide to Obtaining CDSCO License for Flexible Video Duodenoscope (Reusable) – Class B Medical Device

As a reusable flexible video duodenoscope, this medical device plays a critical role in gastroenterology by enabling accurate visual examination and therapeutic interventions in the duodenum, the initial segment of the small intestine. Given its direct contact with sterile internal tissues and its reusable nature, regulatory compliance is paramount to ensure patient safety and device efficacy. In India, such devices are classified as Class B under the Central Drugs Standard Control Organization (CDSCO) regulatory framework, necessitating specific licensing protocols before manufacturing or import.

Having successfully assisted over 500 companies in navigating the complex CDSCO licensing process, we provide an expert, step-by-step guide tailored for manufacturers and importers of reusable flexible video duodenoscopes.

CDSCO Regulatory Framework for Flexible Video Duodenoscope (Reusable)

The CDSCO governs medical device regulation in India under the Medical Device Rules, 2017. The flexible video duodenoscope falls under the gastroenterology category and is notified under the Gazette Notification No. 29/Misc./03/2020-DC (182) dated 27.09.2021. This classification as a Class B device means it is considered low-moderate risk, requiring a manufacturing license (MD5) issued by the State Licensing Authority.

Compliance with Indian medical device standards, sterile processing protocols, and quality management systems (ISO 13485:2016) is mandatory. The device must also adhere to the Essential Principles of Safety and Performance as outlined by CDSCO.

Risk Classification and License Requirements for Flexible Video Duodenoscope (Reusable)

Class B devices, such as reusable flexible video duodenoscopes, are classified as low to moderate risk. Consequently, manufacturers are required to obtain an MD5 manufacturing license before commencing production. The MD5 license process involves:

• Obtaining a Test License (Form MD13)
• Conducting product testing at CDSCO-approved laboratories
• Submitting a comprehensive application (Form MD3) for the MD5 license
• Undergoing an audit by a notified body

For detailed classification, you can visit our Medical Device Classification resource.

Manufacturing License Process (MD5) for Flexible Video Duodenoscope

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, a test license is mandatory. This allows for product testing and validation.

• Timeline: Approximately 1.5 to 2 months
• Process: Submit Form MD13 via the CDSCO MD Online Portal

Step 2: Product Testing

Test your reusable flexible video duodenoscope at a CDSCO-recognized testing laboratory. Testing typically covers biocompatibility, sterilization validation, electrical safety, and performance standards.

• Find authorized labs here: Testing Laboratories
• Tip: Early engagement with testing labs can mitigate delays.

Step 3: Prepare Application (Form MD3) for MD5 License

Compile all required documentation and submit the manufacturing license application through the CDSCO portal.

Step 4: Audit by Notified Body

An on-site audit of your manufacturing facility and quality systems will be conducted by a notified body listed here: Notified Bodies List for MD5 Audit.

Step 5: Respond to Queries & License Grant

Address any observations raised during audit or by CDSCO officials promptly to facilitate license approval.

Manufacturing License Documents Required for Flexible Video Duodenoscope

To expedite your MD5 license application, ensure submission of the following comprehensive documents:

• Company constitution documents (e.g., incorporation certificate)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire safety and pollution control clearances
• Device Master File (DMF) detailing design, manufacturing process, and validation (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing environment and quality controls (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test reports from CDSCO-approved labs
• Product labels and Instructions For Use (IFU) in English and regional languages
• Quality Management System (QMS) documents including ISO 13485 certification

Import License Process (MD15) for Flexible Video Duodenoscope

If you are an importer of reusable flexible video duodenoscopes, obtaining an MD15 import license from the CDSCO Central Licensing Authority is mandatory.

Process Overview:

• Prepare and submit Form MD14 application through the CDSCO MD Online Portal
• Include all requisite documents (listed below)
• Respond promptly to any CDSCO queries
• Await license grant on Form MD15

Note: Test license is not required for import license.

Import License Documents Required

• Valid manufacturing license of the foreign manufacturer
• Free Sale Certificate or Certificate of Market Authorization from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent quality certification
• Device Master File and Plant Master File
• Wholesale license for distribution in India
• Company constitution and address proof

Full details and professional assistance can be found in our Import License Guide.

Timeline and Processing Duration

Pro Tip: Initiate documentation and testing early to align timelines and avoid bottlenecks.

Government Fees and Costs

For the flexible video duodenoscope (Class B), the fee structure is as follows:

• MD5 Manufacturing License:
  • Application fee: Rs 5,000
  • Per product fee: Rs 500
• MD13 Test License:
  • Fees vary; consult CDSCO portal
• MD15 Import License:
  • Site fee: $2,000 USD
  • Per product fee: $1,000 USD

Note that additional costs may include testing fees, audit charges, and consultancy fees if outsourcing the process.

Common Challenges and Solutions

Challenge: Delays in Product Testing

Solution: Early selection of CDSCO-approved labs and pre-submission consultations can expedite testing. Maintain clear communication to track progress.

Challenge: Incomplete Documentation

Solution: Use detailed checklists, such as those found in our MD5 License Guide, to ensure completeness. Engage experienced consultants for document preparation.

Challenge: Audit Non-Compliance

Solution: Regular internal audits and training of personnel on CDSCO requirements reduce audit findings. Prepare a mock audit prior to official inspection.

Challenge: Query Resolution Delays

Solution: Assign dedicated regulatory personnel or consultants to respond quickly and accurately to CDSCO queries.

Expert Consultation and Support

With over 25 years of regulatory consultancy experience and supporting 500+ companies, we specialize in guiding manufacturers and importers of gastroenterology devices like flexible video duodenoscopes through CDSCO licensing. Our services include:

• Comprehensive documentation support
• Strategic planning of testing and audits
• Liaison with CDSCO and notified bodies
• Training and compliance gap analysis

Leverage our expertise to minimize risks and accelerate your market entry.

Getting Started with Your CDSCO License Application for Flexible Video Duodenoscope

1. Assess your Device Classification: Confirm your device as Class B to determine the correct licensing pathway.
2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to access application forms and status tracking.
3. Compile Essential Documents: Begin gathering your Device Master File, Plant Master File, QMS certificates, and related documents.
4. Apply for Test License (MD13): Submit your application early to initiate product testing.
5. Schedule Testing: Engage a CDSCO-approved laboratory and coordinate sample submissions.
6. Prepare for Audit: Align your manufacturing practices with CDSCO standards and notified body requirements.
7. Submit MD5 License Application (Form MD3): Once testing is complete, file your manufacturing license application.
8. Monitor and Respond: Track application status actively and respond promptly to any queries.

Starting your CDSCO licensing journey with a clear roadmap and expert support ensures compliance and smooth market access for your reusable flexible video duodenoscope. Contact us today to leverage our deep regulatory expertise and accelerate your licensing process.