CDSCO License for Positron camera
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
A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body.
Comprehensive Guide to CDSCO Licensing for Positron Camera (Class A Medical Device)
As specialists with over 25 years of experience in medical device regulatory affairs, we understand the complexities manufacturers and importers face when entering the Indian market. The Positron Camera, a Class A medical device used in Interventional Radiology to image positron-emitting radionuclides in the body, requires specific compliance under the CDSCO framework, especially following the official notification 29/Misc./03/2020-DC (146) dated 26.07.2021.
Navigating the regulatory landscape efficiently can save valuable time and resources. Here, we provide an in-depth, practical guide tailored for Positron Camera manufacturers and importers to help you secure your CDSCO license seamlessly.
CDSCO Regulatory Framework for Positron Cameras
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since Positron Cameras fall under Class A—considered low risk—they are regulated by the State Licensing Authority, requiring an MD5 manufacturing license for local production or an MD15 import license for importers.
Compliance with the Medical Devices Rules 2017 and subsequent notifications ensures your product meets safety, efficacy, and quality standards mandated by CDSCO. The notification 29/Misc./03/2020-DC (146) specifically classifies Positron Cameras under Class A devices in the Interventional Radiology category, guiding the applicable licensing and testing protocols.
Risk Classification and License Requirements for Positron Cameras
- Risk Class: A (Low Risk)
- Applicable License: MD5 (Manufacturing License) for Indian manufacturers
- Regulatory Authority: State Licensing Authority
Positron Cameras classified as Class A devices require adherence to the MD5 licensing process, which involves obtaining a Test License (Form MD13), conducting product testing at government-approved labs, and passing a notified body audit.
For comprehensive classification details, visit our Medical Device Classification guide.
Manufacturing License Process (MD5) for Positron Cameras
Apply for Test License (Form MD13): The process begins with applying for a test license on the CDSCO MD Online Portal, allowing you to legally manufacture the device for testing purposes. This stage typically takes 1.5 to 2 months.
Product Testing: Get the Positron Camera tested at government-approved testing laboratories listed on the CDSCO Testing Laboratories page. Test reports must comply with Indian regulatory standards.
Document Preparation: Prepare the required documentation, including the Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Apply for MD5 License (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal. This initiates the audit process.
Audit by Notified Body: A notified body from the approved list (Notified Bodies) will conduct a detailed audit of your manufacturing facility and quality management systems.
Query Resolution: Address any queries raised by the State Licensing Authority or notified body promptly.
Grant of License: Upon successful audit and document verification, the MD5 license (Form MD5) will be granted.
For detailed guidance, refer to our MD5 License Guide.
Manufacturing License Documents Required for Positron Cameras
Manufacturing a Positron Camera in India involves submitting the following documents:
- Company Constitution or Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification Documents
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed product specifications and manufacturing process documentation. Learn more in our Device Master File Guide.
- Plant Master File (PMF): Details of the manufacturing facility, equipment, and quality control systems. Our Plant Master File Guide can help prepare this.
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File highlighting identified risks and mitigation strategies (see our Risk Management insights)
- Test Reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certification
Compiling these documents with accuracy and completeness is critical to avoid delays.
Import License Process (MD15) for Positron Cameras
Though Positron Cameras are Class A devices, importers must obtain an MD15 license from the Central Licensing Authority, which generally takes 5-6 months.
Key steps include:
- Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries from the CDSCO.
- Grant of MD15 import license.
For detailed import licensing procedures, check our Import License Guide.
Timeline and Processing Duration for Positron Camera Licensing
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application, lab testing approval |
| MD5 Manufacturing License | 3 - 4 months total | Audit, query resolution, license grant |
Overall, manufacturers should anticipate a total timeline of approximately 3-4 months from test license application to final license issuance.
Government Fees and Costs for Positron Camera MD5 License
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per device
Additional costs to consider include notified body audit charges, testing laboratory fees, and costs for document preparation and consulting services.
Common Challenges and Solutions
Incomplete Documentation: Missing or improperly prepared Device Master Files or Risk Management Files can cause significant delays. We recommend early preparation with expert consultation.
Delayed Testing Approvals: Testing laboratories may have backlogs; schedule testing well in advance.
Audit Non-Compliance: Ensure your manufacturing site and QMS adhere strictly to notified body expectations by conducting internal pre-audits.
Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to avoid processing bottlenecks.
Our team has successfully helped over 500 companies overcome these hurdles efficiently.
Expert Consultation and Support
Engaging with experienced regulatory consultants can streamline your CDSCO licensing journey. We offer end-to-end support—from document preparation and application submission to audit readiness and government liaison.
Getting Started with Your CDSCO License Application for Positron Cameras
- Assess Your Risk Classification: Confirm the device class via the official CDSCO notifications.
- Prepare Required Documentation: Start compiling your Device Master File, Plant Master File, Risk Management File, and related documents.
- Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with government-approved testing laboratories early.
- Plan for Notified Body Audit: Select an approved notified body and prepare your facility.
- Submit Manufacturing License Application (MD5): Once testing and documentation are complete, apply for the manufacturing license.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can confidently navigate the CDSCO approval process for Positron Cameras, entering the Indian market with compliance and efficiency.
