CDSCO License for Endometrial biopsy curette, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Endometrial Biopsy Curette (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we understand the nuances of India’s medical device regulatory landscape. If you manufacture or import a reusable endometrial biopsy curette—a Class B obstetrical and gynecological surgical instrument used for removing endometrial tissue for biopsy—this guide will provide you with precise, actionable steps for securing your CDSCO manufacturing or import license efficiently.

CDSCO Regulatory Framework for Reusable Endometrial Biopsy Curette

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, amended periodically. Your device, classified as Class B per the MDR (medium risk), falls under State Licensing Authority jurisdiction for manufacturing licenses and Central Licensing Authority for imports. The regulatory framework ensures patient safety and device efficacy by mandating proper licensing, testing, documentation, and audits.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. The reusable endometrial biopsy curette’s classification as Class B means you must obtain an MD5 manufacturing license (Form MD3) from the State Licensing Authority. For imports, an MD15 license is required from the Central Licensing Authority.

Refer to the Medical Device Classification guide for a detailed overview.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process for reusable endometrial biopsy curettes typically spans 3 to 4 months and involves the following steps:

1. Test License (Form MD13): Apply for a test license to manufacture and test your device sample; this step takes about 1.5 to 2 months.
2. Product Testing: Submit your device samples to government-approved testing laboratories for safety and performance validation. Use the CDSCO Testing Laboratories list.
3. Document Preparation: Compile all required documentation including technical files and compliance reports.
4. License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal along with fees.
5. Audit by Notified Body: An audit conducted by a notified body per the notified list ensures your facility and process meet regulatory standards. Find the list of notified bodies here.
6. Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body.
7. Grant of License (Form MD5): Upon successful completion, you receive your manufacturing license allowing commercial production.

Manufacturing License Documents Required

For a reusable endometrial biopsy curette, you must prepare the following comprehensive documentation to support your MD5 application:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF): Details on design, specifications, and manufacturing processes. Explore our Device Master File guide.
• Plant Master File (PMF): Manufacturing site layout, equipment, and quality controls. Refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian MDR
• Risk Management File demonstrating identification and mitigation of hazards (Risk Management guidance)
• Government-approved Test Reports validating device safety and performance
• Product Labels and Instructions for Use (IFU) compliant with MDR requirements
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Reusable Endometrial Biopsy Curette

If you plan to import the reusable endometrial biopsy curette, you must obtain an MD15 import license from the CDSCO Central Licensing Authority.

The process typically takes 5 to 6 months and involves:

1. Document Preparation: Prepare manufacturing license, free sale certificate from the country of origin, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company incorporation documents.
2. Application Submission: File your import license application using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Address any additional information requests from the CDSCO promptly.
4. Grant of License: Upon acceptance, the MD15 license authorizes import and distribution within India.

For detailed guidance, see our Import License guide.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License for distribution within India
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

Timelines can be influenced by the completeness of your application and responsiveness to CDSCO queries.

Government Fees and Costs

For manufacturing the reusable endometrial biopsy curette (Class B device), the fee structure is as follows:

• MD5 License: Rs. 5000 per application + Rs. 500 per product

For import licenses (MD15), the fees vary by risk class:

• For Class B: Approximately $2000 per site +$1000 per product

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Practical Solutions

1. Delays Due to Incomplete Documentation: Ensure all forms, certificates, and technical files are meticulously prepared. Utilize expert checklists such as our Device Master File guide to avoid omissions.

2. Testing Lab Backlogs: Plan product testing early with government-recognized labs. Contact multiple labs from the CDSCO Testing Laboratories list to schedule tests timely.

3. Audit Readiness: Prepare your facility and QMS documentation ahead of the notified body audit. Conduct internal mock audits using the Notified Bodies list to identify gaps.

4. Regulatory Updates: Stay informed about MDR amendments and notifications, such as your device’s specific notification (File No. 29/Misc./03/2020-DC (181), dated 03.6.2022).

Expert Consultation and Support

Navigating the CDSCO licensing process for reusable endometrial biopsy curettes requires precise knowledge and detailed preparation. Our seasoned regulatory consultants provide end-to-end support—from document drafting and application submission to audit facilitation and post-license compliance. We streamline timelines and mitigate risks, ensuring a smooth path to market.

Getting Started with Your CDSCO License Application

Step 1: Assess your device classification and determine the appropriate license type (MD5 for manufacturing).

Step 2: Initiate documentation compilation, focusing on your Device Master File, Plant Master File, and risk management files.

Step 3: Apply for a test license (Form MD13) via the CDSCO MD Online Portal and coordinate product testing with accredited labs.

Step 4: Prepare for notified body audits by reviewing QMS and facility readiness.

Step 5: Submit your MD5 license application (Form MD3) once testing and audits are complete.

Step 6: Maintain proactive communication with CDSCO to address queries promptly and avoid delays.

By following these steps with expert guidance, manufacturers and importers of reusable endometrial biopsy curettes can successfully obtain their CDSCO licenses and confidently enter the Indian medical device market.

For personalized assistance, please contact our regulatory consultancy to leverage our extensive experience and ensure compliance excellence.