CDSCO License for Radiographic film/cassette changer programmer
Medical Device Information
Intended Use
A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.
Comprehensive Guide to CDSCO Licensing for Radiographic Film/Cassette Changer Programmers (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the complexities manufacturers and importers face when entering the Indian medical device market. This guide focuses on the Radiographic Film/Cassette Changer Programmer—a Class B medical device used in interventional radiology to control film or cassette changers during serial medical radiography.
Understanding the Device and Regulatory Importance
A Radiographic Film/Cassette Changer Programmer is a critical device that automates the switching of radiographic films or cassettes to enhance imaging workflow and accuracy. Given its role in diagnostic imaging, regulatory compliance ensures safety, reliability, and adherence to Indian medical device standards as per notification [29/Misc./03/2020-DC (146)] dated 26.07.2021.
CDSCO Regulatory Framework for Radiographic Film/Cassette Changer Programmers
In India, the Central Drugs Standard Control Organization (CDSCO) governs medical device regulation under the Medical Device Rules, 2017. Since the Radiographic Film/Cassette Changer Programmer falls under Class B (low-moderate risk), the licensing authority is the State Licensing Authority, and the applicable manufacturing license is an MD5 license.
Risk Classification and License Requirements
- Risk Class: B (Low to Moderate Risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Regulatory Authority: State Licensing Authority
- Total Processing Time: Approximately 3-4 months
For detailed classification, manufacturers can refer to our Medical Device Classification guide.
Manufacturing License Process (MD5)
- Test License (Form MD13): Before applying for the MD5 license, you must obtain a test license for the device, which takes about 1.5 to 2 months.
- Product Testing: The device must be tested at government-approved laboratories to verify compliance with Indian standards. A list of such Testing Laboratories can be accessed.
- Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
- Application Submission: File the application using Form MD3 for the MD5 license on the CDSCO MD Online Portal.
- Audit by Notified Body: An audit by a notified body is mandatory. Refer to the Notified Bodies List for authorized auditors.
- Query Resolution: Address any queries raised by the licensing authority or the notified body promptly.
- License Grant: Upon satisfactory compliance, the MD5 license is granted.
Manufacturing License Documents Required
- Company Constitution (Incorporation Certificate, MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) – see our detailed Device Master File guide
- Plant Master File (PMF) – learn how to create one in our Plant Master File guide
- Essential Principles Checklist (EPC)
- Risk Management File – refer to our Risk Management guide
- Product Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485:2016 preferred)
Import License Process (MD15)
Although this guide focuses on manufacturing, importers seeking to bring Radiographic Film/Cassette Changer Programmers into India must apply for an MD15 import license:
- Authority: Central Licensing Authority
- Application Form: MD14
- Timeline: Approximately 5-6 months
- Documentation: Includes manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, DMF, PMF, wholesale license, and company constitution.
For an in-depth understanding, check our Import License Guide.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Review & Audit | 4 – 6 weeks |
| Query Resolution & Final Grant | 2 – 4 weeks |
Total Estimated Time: 3-4 months from start to license grant.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B Device) | Rs 5,000 | Rs 500 |
Additional costs include laboratory testing fees (variable), notified body audit charges (variable), and consultancy fees if engaging a regulatory expert.
Common Challenges and Solutions
- Incomplete Documentation: Early preparation of comprehensive Device and Plant Master Files helps avoid delays.
- Delayed Product Testing: Engage government-approved labs early and schedule testing to accommodate potential backlog.
- Audit Non-Conformities: Familiarize yourself with notified body requirements from the Notified Bodies List and conduct internal audits beforehand.
- Query Resolution Delays: Allocate dedicated resources to promptly address CDSCO or auditor queries.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex. Our team’s extensive experience ensures:
- Accurate classification and license type determination
- Robust document preparation including DMF and PMF
- Coordination with notified bodies and testing labs
- Efficient query management and follow-up
- End-to-end support from application to license grant
Getting Started with Your CDSCO License Application
- Assess your device classification to confirm it falls under Class B.
- Prepare your test license (MD13) application immediately through the CDSCO MD Online Portal.
- Identify and coordinate with a government-approved testing laboratory early on to schedule product testing.
- Begin compiling essential documentation—focus on the Device Master File and Plant Master File as these are often time-intensive.
- Engage a notified body for pre-audit readiness to avoid non-compliance issues during the official audit.
- Submit your manufacturing license application (MD3) for the MD5 license once product testing is complete.
- Maintain consistent communication with CDSCO authorities to swiftly handle any queries.
By following these actionable steps and leveraging expert guidance, manufacturers and importers of Radiographic Film/Cassette Changer Programmers can significantly streamline their entry into the Indian medical device market with full regulatory compliance.
For more tailored support or detailed consultation, feel free to connect with us and benefit from our proven track record in CDSCO licensing success.
