CDSCO License for Ophthalmic distometer
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
An ophthalmic instrument designed to measure the distance between the cornea and a spectacle or trial lens (vertex distance).
Comprehensive Guide to CDSCO Licensing for Ophthalmic Distometer (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the critical importance of timely, accurate compliance for medical devices like the Ophthalmic Distometer. This ophthalmic instrument, designed to measure the vertex distance between the cornea and spectacle or trial lens, falls under Class A – the lowest risk category – but still mandates a rigorous licensing process under Indian regulations.
CDSCO Regulatory Framework for Ophthalmic Distometer
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. Since the notification Fts No. 29/MiscJO3/2020-DC (187) on 9.8.2021, ophthalmic devices including the Ophthalmic Distometer have been explicitly classified under CDSCO’s regulatory ambit. Compliance ensures your device meets safety, quality, and efficacy standards essential for patient safety and market access.
Risk Classification and License Requirements for Ophthalmic Distometer
Your device is categorized as Class A, indicating low risk. Under the CDSCO framework, Class A devices require an MD5 manufacturing license granted by the State Licensing Authority. This license involves a streamlined process compared to higher-risk classes but still mandates essential documentation, testing, and audits.
Manufacturing License Process (MD5) for Ophthalmic Distometer
The MD5 license process is sequential and typically spans 3 to 4 months, consisting of the following phases:
Test License Application (Form MD13): Before full license application, you must obtain a test license to manufacture and test the device in limited quantities. This takes about 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to prove compliance. Refer to the list of testing laboratories for authorized facilities.
Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, risk management files, and quality management system documents.
License Application (Form MD3): Submit the complete application for MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an on-site audit to verify facility compliance. You can check the list of notified bodies for authorized auditors.
Query Resolution: Address any queries raised by the CDSCO or notified body promptly to avoid delays.
Grant of License: Upon successful audit and documentation review, the MD5 license is granted on Form MD5.
Manufacturing License Documents Required
For the Ophthalmic Distometer, you will need the following critical documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, manufacturing, and technical specifications (Device Master File Guide)
- Plant Master File outlining manufacturing processes and quality systems (Plant Master File Guide)
- Essential Principles Checklist ensuring device compliance with Indian regulatory standards
- Risk Management File aligned with ISO 14971 principles (Risk Management)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) complying with CDSCO labeling regulations
- Quality Management System (QMS) documents, preferably aligned with ISO 13485:2016
Import License Process (MD15) for Ophthalmic Distometer
If you plan to import the Ophthalmic Distometer, the MD15 import license issued by the Central Licensing Authority is required. Unlike manufacturing, the import license process does not require a test license but involves thorough document verification, including:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license in India
- Company Constitution
The process takes approximately 5 to 6 months, with fees dependent on device class.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 3 weeks |
| Application Submission | Immediate upon readiness |
| Audit and Inspection | 4 to 6 weeks |
| Query Resolution & Grant | 2 to 3 weeks |
Total: Approximately 3 to 4 months for MD5 license.
Government Fees and Costs
For Class A devices like Ophthalmic Distometer, the government fees are as follows:
- Rs 5,000 per license application
- Rs 500 per product for each device variant
Additional costs may include fees for notified body audits, product testing, and consultancy support.
Common Challenges and Solutions
- Delays in Testing: Testing labs often face backlogs. Plan early and select labs strategically from the CDSCO-approved testing laboratories.
- Incomplete Documentation: Missing or inconsistent documents cause rejections. Use detailed checklists and expert reviews.
- Audit Non-Compliance: Facilities may fail audits due to inadequate QMS or poor premises maintenance. Conduct internal audits before notified body visits.
- Query Management: Slow responses can stall approvals. Designate a dedicated regulatory liaison for efficient communication.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be intricate. Our seasoned consultants, with decades of hands-on experience, offer tailored support ranging from document preparation, audit readiness, to application submission. We've successfully guided over 500 manufacturers and importers through these exact procedures, ensuring compliance and timely approvals.
Getting Started with Your CDSCO License Application for Ophthalmic Distometer
- Assess Device Classification: Confirm your device’s Class A status and understand regulatory obligations.
- Initiate Test License (MD13) Application: Collect initial documents and submit through the CDSCO MD Online Portal.
- Schedule Product Testing: Engage CDSCO-approved labs early to avoid bottlenecks.
- Prepare Comprehensive Documentation: Leverage templates and expert guides for Device Master File and Plant Master File.
- Plan for Notified Body Audit: Select a notified body from the official list and schedule audits.
- Submit MD5 License Application: After successful test license and testing, apply for the manufacturing license via the online portal.
- Respond to Queries Promptly: Monitor application status and address any regulatory queries without delay.
For detailed assistance and a personalized roadmap, contact our expert team today. Our proven approach ensures your Ophthalmic Distometer is compliant, market-ready, and positioned for success in the Indian healthcare sector.
