CDSCO License for Hysteroscopic insufflator

Comprehensive Guide for CDSCO Licensing of Hysteroscopic Insufflator (Class B Medical Device)

As a medical device manufacturer or importer aiming to enter the Indian market, understanding the regulatory framework for your Hysteroscopic Insufflator is crucial. This device, classified as Class B under CDSCO regulations, serves an important role in obstetrics and gynecology by sending gas into the fallopian tube to maintain tubal patency. With over 25 years of experience and having assisted 500+ companies in obtaining their CDSCO licenses, we provide you with a detailed, practical roadmap tailored specifically for your device.

CDSCO Regulatory Framework for Hysteroscopic Insufflator

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India. Since the notification dated 03.06.2022 (File No. 29/Misc./03/2020-DC (181)), your Hysteroscopic Insufflator falls under Class B devices, requiring a State-level manufacturing license (MD5) for production and a Central-level import license (MD15) for importation.

Risk Classification and License Requirements

Your device’s classification as Class B means it is considered low to moderate risk. Consequently, the licensing process is streamlined compared to higher risk devices but still involves rigorous testing and documentation.

• Manufacturing License: MD5 license via State Licensing Authority
• Import License: MD15 license via Central Licensing Authority

For a full understanding of medical device classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Device

The manufacturing license process for your Hysteroscopic Insufflator follows these key steps:

1. Test License Application (Form MD13): Initiate by obtaining a test license, which typically takes 1.5 to 2 months. This allows you to perform product testing at government-approved laboratories.
2. Product Testing: Conduct mandatory product testing through laboratories listed on the CDSCO Testing Laboratories page.
3. Document Preparation: Compile all required documentation including Device Master File, Plant Master File, and risk management documents.
4. Manufacturing License Application (Form MD3): Submit your MD5 application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of your manufacturing facility is conducted by a notified body; you can check the list of notified bodies here.
6. Query Resolution: Address any queries from the authority or notified body promptly.
7. License Grant: Upon successful audit and document verification, the MD5 license is granted.

Manufacturing License Documents Required for Hysteroscopic Insufflator

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – see our Device Master File guide
• Plant Master File (PMF) – detailed in our Plant Master File guide
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File illustrating hazard analysis and mitigation strategies
• Product test reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) in compliance with regulations
• Quality Management System (QMS) documentation (ISO 13485 preferred)

Import License Process (MD15) for Hysteroscopic Insufflator

For importers of the Hysteroscopic Insufflator, the MD15 license is mandatory. The process includes:

1. Document Compilation: Prepare all necessary documents including an existing manufacturing license (if applicable), Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and device-specific files.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Query Management: Respond to any clarification requests from CDSCO promptly.
4. License Issuance: Upon approval, the MD15 import license is granted.

Import License Documents Required

• Manufacturing License of the device
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent conformity assessment
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 2-4 weeks
  • Audit and License Processing: 1-1.5 months

• MD15 Import License: Approximately 5-6 months

Timelines can vary depending on the completeness of documentation and responsiveness during query resolution.

Government Fees and Costs

• MD5 License:

  • Application Fee: Rs 5,000 per application
  • Per Product Fee: Rs 500

• MD15 Import License:

  • For Class B devices: Rs 2,000 per site
  • Rs 1,000 per product

Costs exclude expenses related to product testing, notified body audits, and consultancy fees.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles.

Solution: Engage regulatory experts to pre-review documents and ensure alignment with CDSCO guidelines to avoid back-and-forth.

Challenge: Difficulty in coordinating audits with notified bodies.

Solution: Schedule audits well in advance and select notified bodies from the official list of notified bodies.

Challenge: Product testing delays due to lab backlog.

Solution: Initiate testing early and use multiple CDSCO-approved labs if possible.

Expert Consultation and Support

With our extensive experience guiding over 500 companies through the CDSCO licensing maze, we offer tailored support including document preparation, audit readiness, and liaison with CDSCO officials. Our proactive approach ensures your Hysteroscopic Insufflator licensing is smooth and timely.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status using CDSCO guidelines.
2. Prepare Essential Documentation: Begin compiling your Device Master File, Plant Master File, and risk management documentation.
3. Apply for Test License (MD13): Submit your initial application via the CDSCO MD Online Portal to begin product testing.
4. Select Testing Labs and Notified Body: Engage with approved testing laboratories and notified bodies early in the process.
5. Plan for Audit: Prepare your manufacturing site and QMS for the notified body audit.
6. Submit Manufacturing License Application (MD3): Upon successful testing and audit, apply for your MD5 license.

By following these actionable steps and leveraging expert support, you can confidently navigate the regulatory requirements for your Hysteroscopic Insufflator and successfully access the Indian medical device market.

For detailed guides on MD5 manufacturing licenses and import licenses, visit our MD5 License Guide and Import License Guide.

We look forward to partnering with you on your regulatory journey.