CDSCO License for Synoptophor
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 ophthalmic device used for the evaluation and training of a patient's binocular function.
Comprehensive Guide to CDSCO Licensing for Synoptophor – Class A Ophthalmic Device
Synoptophor is a specialized ophthalmic device designed for the evaluation and training of binocular function in patients. As an essential tool in ophthalmology, it plays a crucial role in diagnosing and managing binocular vision anomalies. Given its classification as a Class A medical device under Indian regulations, obtaining the appropriate CDSCO manufacturing license is mandatory before marketing or manufacturing Synoptophor in India.
With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we understand the nuances and critical requirements to help you efficiently navigate the regulatory landscape for devices like Synoptophor.
CDSCO Regulatory Framework for Synoptophor
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules (MDR) 2017. Synoptophor, notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, falls under the ophthalmology category and is classified as a Class A device, representing low-risk devices.
Manufacturers of Class A devices must obtain a manufacturing license (MD5 license) issued by the respective State Licensing Authority. This framework ensures the device meets safety, quality, and performance standards before entering the Indian market.
Risk Classification and License Requirements for Synoptophor
- Device Name: Synoptophor
- Risk Class: A (Low risk)
- Intended Use: Evaluation and training of binocular function
- Category: Ophthalmology
For Class A devices like Synoptophor, the applicable license is the MD5 license (Application Form MD3). This license is granted by the State Licensing Authority following a thorough evaluation, including product testing and audit.
Manufacturing License Process for Synoptophor (MD5 License)
The manufacturing license process for Synoptophor involves several critical steps:
Test License Application (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license to conduct product testing. This phase typically takes 1.5 to 2 months.
Product Testing: Testing must be performed in government-approved laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories for recognized facilities.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
License Application Submission (Form MD3): Submit the application for the MD5 manufacturing license via the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body is mandatory. You can check the list of notified bodies authorized to conduct audits for Class A devices.
Queries and Clarifications: Address any queries raised by the Licensing Authority or the Notified Body promptly.
Grant of License (Form MD5): Upon successful completion of all steps, the manufacturing license is issued.
For detailed guidance on the MD5 licensing process, refer to our MD5 License Guide.
Manufacturing License Documents Required for Synoptophor
Manufacturers must submit a comprehensive set of documents to comply with CDSCO requirements:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and manufacturing process (Device Master File Guide)
- Plant Master File (PMF) describing the manufacturing facility and quality control processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian MDR
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved laboratories
- Product labels and Instructions For Use (IFU)
- Quality Management System (QMS) documents such as SOPs and quality manuals
Import License Process for Synoptophor (MD15 License)
If you plan to import Synoptophor into India, an import license (MD15) issued by the Central Licensing Authority is required. The process includes:
- Preparing necessary documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and wholesale drug license.
- Applying through the CDSCO MD Online Portal.
- Addressing queries raised by the authority.
- License issuance typically takes 5-6 months.
For detailed steps, see our Import License Guide.
Timeline and Processing Duration
| Activity | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month |
| License Application Processing | 1 month |
| Audit and Query Resolution | 0.5 – 1 month |
| Total Time for MD5 License | 3 – 4 months |
The timeline above reflects typical durations but may vary depending on document readiness and audit scheduling.
Government Fees and Costs
For Class A devices such as Synoptophor, the fee structure is:
- Application fee: Rs 5,000 per application
- Per product fee: Rs 500 per product
Additional costs include testing fees payable to government-approved laboratories and audit fees to notified bodies. Budgeting for documentation preparation and possible consultancy services is also recommended.
Common Challenges and Practical Solutions
Challenge 1: Delays in product testing due to limited slots at approved labs.
- Solution: Schedule testing early and consider multiple labs from the Testing Laboratories list.
Challenge 2: Incomplete documentation causing audit or licensing delays.
- Solution: Use comprehensive checklists and expert consultation to ensure document completeness, especially for DMF and PMF.
Challenge 3: Queries from licensing authority requiring clarifications.
- Solution: Maintain clear communication and respond promptly with supporting evidence.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, but with expert guidance, you can avoid common pitfalls. Our team has successfully helped over 500 manufacturers streamline their applications for Class A devices like Synoptophor. We offer tailored services including documentation review, audit preparation, and end-to-end application management.
Getting Started with Your CDSCO License Application for Synoptophor
Assess Device Classification: Confirm Synoptophor as a Class A device and understand the MD5 license requirements.
Initiate Test License Application: Apply for the test license (Form MD13) via the CDSCO MD Online Portal.
Prepare Documentation: Develop Device and Plant Master Files, Risk Management Files, and quality system documents using our Device Master File guide and Plant Master File guide.
Coordinate Product Testing: Schedule testing at a government-approved laboratory.
Select and Schedule Audit: Engage a notified body from the Notified Bodies list for your audit.
Submit Complete Application: File your MD5 manufacturing license application (Form MD3) online and track status.
Respond to Queries: Prepare to address any department or audit observations swiftly.
By following these actionable steps and leveraging our expert support, you can efficiently obtain your CDSCO manufacturing license for Synoptophor and successfully bring your ophthalmic device to the Indian market.
