CDSCO License for Cervical anaesthesia needle,  reusable or single use

Comprehensive Guide to CDSCO Licensing for Cervical Anaesthesia Needle (Class B Medical Device)

As a specialized medical device manufacturer or importer, understanding the regulatory landscape for your Cervical Anaesthesia Needle is crucial. This sharp, bevel-edged, hollow tubular instrument, designed for intracervical nerve blocks, falls under the Obstetrical and Gynecological category and is classified as a Class B device by CDSCO. With over 25 years of experience and having successfully assisted 500+ companies, we offer you an expert roadmap to navigate the CDSCO licensing process efficiently.

CDSCO Regulatory Framework for Cervical Anaesthesia Needle

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Since June 3, 2022, your device is regulated under File No. 29/Misc./03/2020-DC (181), ensuring compliance with Indian medical device rules. This device requires adherence to the Medical Device Rules 2017 (MDR 2017), focusing on safety, efficacy, and quality.

Risk Classification and License Requirements for Your Device

Cervical Anaesthesia Needle is classified as a Class B medical device, which implies moderate risk. Consequently, manufacturers must obtain an MD5 manufacturing license from the State Licensing Authority before production. Importers will require an MD15 import license from the Central Licensing Authority.

• Manufacturing License: MD5 (Form MD3) via State Authority
• Import License: MD15 (Form MD14) via Central Authority

Refer to the Medical Device Classification guide for further risk class details.

Manufacturing License Process (MD5) for Cervical Anaesthesia Needle

The MD5 license process is sequential and requires meticulous preparation:

1. Test License Application (Form MD13): Apply for a test license which generally takes 1.5 to 2 months. This allows sample testing of your device in government-approved laboratories.
2. Product Testing: Get your Cervical Anaesthesia Needle tested in notified labs to verify compliance with Indian standards.
3. Document Preparation: Compile necessary documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) documents.
4. License Application (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit: Undergo a facility audit conducted by a notified body from the Notified Bodies List.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful audit and document verification, the MD5 license will be granted.

For a detailed stepwise process, review our MD5 License Guide.

Manufacturing License Documents Required for Cervical Anaesthesia Needle

Prepare the following documents to ensure a smooth application process:

• Company Constitution (e.g., Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our comprehensive Device Master File guide offers practical tips.
• Plant Master File (PMF) describing manufacturing site and quality controls. Learn more in our Plant Master File Guide.
• Essential Principles Checklist ensuring regulatory compliance
• Risk Management File documenting hazard analysis and mitigation strategies
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Cervical Anaesthesia Needle

If you plan to import this device into India, the MD15 import license from CDSCO’s Central Licensing Authority is mandatory:

1. Document Preparation: Compile documents including manufacturing license, Free Sale Certificate from country of origin, ISO 13485:2016 certification, CE certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
2. License Application: Submit the MD15 application on the CDSCO MD Online Portal.
3. Query Resolution: Address any clarifications raised by the CDSCO promptly.
4. License Grant: Receive the MD15 import license upon successful review.

For in-depth guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC)
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

Planning your project timeline with these durations in mind will help avoid costly delays and ensure timely market access.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 Import License (Class B):

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs may include notified body audit fees, testing charges at government-approved labs, and consultancy fees if you seek expert assistance.

Common Challenges and Solutions

1. Delays in Product Testing: Government labs often have backlogs. To mitigate, submit your samples early and consider multiple approved testing labs listed on the Testing Laboratories page.

2. Documentation Gaps: Incomplete or inconsistent documents cause queries. Utilize our Device Master File and Plant Master File guides to prepare comprehensive dossiers.

3. Audit Non-Compliance: Lack of readiness for notified body audits can lead to license denial. Conduct internal audits and pre-assessment reviews to ensure compliance.

4. Regulatory Updates: Keep abreast of CDSCO notifications and amendments to avoid non-compliance.

Expert Consultation and Support

Navigating the CDSCO licensing journey can be complex. Our seasoned regulatory consultants bring unparalleled expertise in handling Class B device registrations, specifically for devices like the Cervical Anaesthesia Needle. We provide:

• Complete documentation review
• Coordination with notified bodies and testing labs
• Timely application submissions and query management
• Post-license compliance support

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

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your classification as Class B through CDSCO guidelines.
2. Prepare Documentation: Initiate your Device Master File and Plant Master File using our expert guides.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start product testing.
4. Engage a Notified Body: Select an authorized notified body from the Notified Bodies List to plan your audit.
5. Plan Your Timeline: Allocate 3-4 months for the entire MD5 license process including testing and audit.
6. Consult with Experts: Consider partnering with experienced regulatory consultants to streamline the process.

Embarking on the CDSCO licensing process for your Cervical Anaesthesia Needle with this strategic approach will position your product for successful entry into the Indian market. For personalized assistance, reach out to our team of regulatory specialists ready to guide you every step of the way.