CDSCO License for Cervical cytology scraper, reusable
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
blunt surgical instrument used to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a reusable device.
Comprehensive Guide to CDSCO Licensing for Cervical Cytology Scraper, Reusable
As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 companies in acquiring CDSCO licenses, we understand the critical nuances of navigating the Indian medical device regulatory landscape. This guide provides an in-depth, actionable roadmap for manufacturers and importers aiming to obtain the necessary CDSCO license for the Cervical Cytology Scraper, Reusable—a Class A oncology device used for cytological sampling in cervical cancer detection.
Understanding the Device and Its Regulatory Importance
The cervical cytology scraper is a blunt surgical instrument designed to gently scrape and collect cytological material from the cervix or vaginal area. Its reusable nature calls for stringent quality control and compliance to ensure patient safety and diagnostic accuracy. Given the device's role in early cervical cancer detection, regulatory approval by the Central Drugs Standard Control Organization (CDSCO) is mandatory before market entry in India.
CDSCO Regulatory Framework for Cervical Cytology Scraper (Reusable)
This device falls under Class A, the lowest risk category, as per the CDSCO medical device classification. Class A devices are regulated primarily at the state level, making the MD5 manufacturing license the relevant authorization for domestic manufacturers. Importers seeking to bring this device into India will need an MD15 import license issued by the central licensing authority.
The regulatory pathway involves compliance with the Medical Device Rules, 2017, and adherence to quality standards such as ISO 13485:2016.
Risk Classification and License Requirements
- Risk Class: A (Low risk)
- License Type:
- Manufacturing: MD5 License (Application Form MD3)
- Import: MD15 License (Application Form MD14)
- Regulatory Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import
For a detailed understanding of device classification, refer to our Medical Device Classification guide.
Manufacturing License Process for Cervical Cytology Scraper (MD5)
The MD5 license process involves several critical steps:
Obtain Test License (Form MD13): Before applying for the manufacturing license, manufacturers must secure a test license. This takes approximately 1.5 to 2 months.
Product Testing: Conduct testing of the cervical cytology scraper at a CDSCO-approved laboratory. You can find a list of accredited labs on the CDSCO Testing Laboratories page.
Document Preparation: Compile necessary documentation including Device Master File, Plant Master File, and Quality Management System (QMS) records.
Application Submission: File the MD5 license application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts a compliance audit. Refer to the notified bodies list for authorized auditors.
Query Resolution: Address any queries raised during the audit or by the licensing authority promptly.
License Grant: Upon successful review, the MD5 license is granted.
The entire process typically takes 3 to 4 months, assuming timely compliance and no major audit observations.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following detailed documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Personnel
- Fire Safety NOC and Pollution Control Board NOC
- Comprehensive Device Master File outlining design, manufacturing process, and specifications (Device Master File guide)
- Plant Master File detailing manufacturing environment and quality controls (Plant Master File guide)
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File addressing potential hazards and mitigation strategies (Risk Management overview)
- Test Reports from CDSCO-approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliant)
Import License Process for Cervical Cytology Scraper (MD15)
For importers, the MD15 license application process includes:
Document Compilation: Gather all mandatory documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate if applicable, and Device and Plant Master Files.
Application Submission: Submit the application on the CDSCO MD Online Portal.
Queries and Clarifications: Respond promptly to any department queries.
License Issuance: Upon satisfactory review, the MD15 import license is granted.
The typical timeline for import license approval is 5 to 6 months.
Import License Documents Required
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for importer
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| Process Step | Approximate Timeframe |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 month |
| Documentation Prep | 2 – 3 weeks |
| MD5 Application Review | 1 – 2 months |
| Audit & Query Closure | 2 – 4 weeks |
| Total for MD5 | 3 – 4 months |
| Process Step | Approximate Timeframe |
|---|---|
| Document Preparation | 1 month |
| MD15 Application Review | 3 – 4 months |
| Query Resolution | 1 month |
| Total for MD15 | 5 – 6 months |
Government Fees and Costs
MD5 License (Class A Device):
- Application Fee: INR 5,000
- Per Product Fee: INR 500
MD15 Import License:
- Site Fee: USD 1,000 (approx. INR 80,000)
- Per Product Fee: USD 50 (approx. INR 4,000)
Budgeting for these fees upfront helps avoid delays.
Common Challenges and Solutions
Challenge: Delays in audit scheduling and query resolution.
Solution: Engage with notified bodies and maintain open communication to expedite audits. Prepare comprehensive, clear responses to queries.
Challenge: Incomplete or inconsistent documentation, especially related to Device and Plant Master Files.
Solution: Utilize expert guidance and templates available in our Device Master File guide and Plant Master File guide.
Challenge: Testing delays due to lab backlogs.
Solution: Identify and book slots early at CDSCO-approved labs found on the Testing Laboratories list.
Expert Consultation and Support
With our extensive experience assisting over 500 medical device companies, we provide end-to-end CDSCO licensing support tailored to cervical cytology scrapers and similar Class A devices. Our services include:
- Comprehensive gap analysis of documentation
- Coordination with notified bodies for audits
- Assistance with test license and product testing
- Timely response management for CDSCO queries
Contact us to streamline your regulatory journey with proven expertise.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm that your cervical cytology scraper is classified as Class A.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and QMS documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start the testing phase.
- Plan Testing: Schedule product testing at an approved laboratory early to avoid bottlenecks.
- Engage a Notified Body: Identify and appoint a notified body for your audit.
- Submit License Application: Once testing and audit are completed, file your MD5 application.
- Maintain Compliance: Prepare to respond promptly to any queries and maintain open communication with regulatory authorities.
By following these steps and leveraging expert support, manufacturers and importers can efficiently navigate the CDSCO licensing process for the reusable cervical cytology scraper, ensuring timely market access and regulatory compliance.
