CDSCO License for Periocular/lacrimal retractor
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 hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention.
Comprehensive Guide to CDSCO Licensing for Periocular/Lacrimal Retractor (Class A Medical Device)
Manufacturers and importers aiming to introduce the Periocular/lacrimal retractor in India must navigate the stringent regulatory landscape established by the Central Drugs Standard Control Organization (CDSCO). This ophthalmic surgical instrument is classified as a Class A medical device under the CDSCO framework, representing the lowest risk category but still requiring robust compliance to ensure patient safety and market access.
At our consultancy, with over 25 years of experience and having assisted 500+ companies, we provide expert insights into securing CDSCO licensing specifically for Class A devices like the periocular/lacrimal retractor. This article delivers a detailed, step-by-step roadmap covering regulatory requirements, documentation, timelines, fees, and practical advice to help you successfully launch your product in the Indian market.
CDSCO Regulatory Framework for Periocular/Lacrimal Retractor
The periocular/lacrimal retractor falls under the ophthalmology category and is notified under FTS No. 29/MiscJO3/2020-DC (187), dated 9.8.2021. As a Class A device, it is considered low risk and hence subject to the MD5 manufacturing license, issued by the respective State Licensing Authority.
The regulatory framework mandates compliance with the Medical Devices Rules, 2017, and adherence to essential principles covering safety, efficacy, and quality. The device must be tested in CDSCO-approved laboratories, and audits must be conducted by notified bodies before license approval.
Risk Classification and License Requirements for Periocular/Lacrimal Retractor
- Risk Class: Class A (low risk)
- License Type: MD5 Manufacturing License (Form MD3 application)
- Authority: State Licensing Authority
- License Timeline: Approximately 3-4 months
- Testing Requirements: Mandatory product testing in CDSCO-approved labs
- Audit: Required by notified bodies listed on the CDSCO portal
Manufacturers of Class A devices benefit from a streamlined process compared to higher-risk devices but must still ensure comprehensive documentation and compliance.
Manufacturing License Process (MD5) for Class A Devices
The MD5 licensing process for the periocular/lacrimal retractor involves several critical stages:
Test License Application (Form MD13): Before full manufacturing license, you must obtain a test license to conduct product testing. This usually takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-recognized labs to demonstrate compliance with applicable standards. Refer to the List of Testing Laboratories for approved facilities.
Document Preparation: Compile all necessary documents, including technical and quality files.
Manufacturing License Application (Form MD3): Submit the application for the MD5 license via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body (see the Notified Bodies List) to verify manufacturing compliance.
Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body.
Grant of License (Form MD5): Upon satisfactory compliance, the MD5 manufacturing license is granted.
Manufacturing License Documents Required
For the periocular/lacrimal retractor, manufacturers must prepare the following detailed documents:
- Company Constitution: Incorporation certificates, partnership deeds, or trust deeds
- Proof of Ownership or Tenancy of Manufacturing Premises: Rent agreements or property ownership documents
- Technical Staff Details: Qualifications and experience certificates of key personnel
- Fire NOC & Pollution Control NOC: As applicable for manufacturing facilities
- Device Master File (DMF): Comprehensive technical documentation of the device design and manufacturing process. Our Device Master File guide elaborates on this.
- Plant Master File (PMF): Details about manufacturing infrastructure and quality systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist: Mapping device compliance against CDSCO essential principles
- Risk Management File: Documentation of risk analysis and mitigation strategies. Refer to our Risk Management resource for best practices.
- Test Reports: From CDSCO-approved testing laboratories
- Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
- Quality Management System Documentation: SOPs, CAPA, internal audit reports, etc.
Meticulous preparation of these documents is crucial for a smooth audit and approval process.
Import License Process (MD15) for Periocular/Lacrimal Retractor
For importers intending to bring the periocular/lacrimal retractor into India, an MD15 import license from the Central Licensing Authority is mandatory. Unlike manufacturing, the import process does not require a test license but demands extensive documentation:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution and Importer details
Application is submitted via the CDSCO MD Online Portal, and the typical timeline is around 5-6 months.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| Manufacturing License (MD5) | 1.5 to 2 months including audit and query resolution |
Total Time: Approximately 3-4 months for full MD5 license issuance.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Per Product Fee: ₹500 per product
Additional costs may include:
- Testing laboratory fees (varies by lab and test complexity)
- Notified body audit fees
- Consultancy or expert fees if availed
Planning your budget with these costs in mind will help avoid surprises.
Common Challenges and Solutions
Challenge: Delays in test report issuance due to laboratory backlogs.
Solution: Engage with CDSCO-recognized labs early and plan testing schedules proactively.
Challenge: Incomplete documentation leading to audit observations.
Solution: Utilize expert checklists and conduct internal audits before submission. Our detailed guides on Device Master File and Risk Management can be invaluable.
Challenge: Misinterpretation of essential principles checklist.
Solution: Seek professional regulatory consulting to ensure accurate compliance mapping.
Expert Consultation and Support
With our extensive experience supporting over 500 clients, we offer tailored consulting services for periocular/lacrimal retractor manufacturers and importers. From document drafting to audit preparation and query handling, our experts guide you through every step.
We also provide training on CDSCO requirements, risk management implementation, and quality system establishment to ensure sustainable compliance.
Getting Started with Your CDSCO License Application
To initiate your license application for the periocular/lacrimal retractor:
Classify your device clearly as Class A according to CDSCO guidelines. Confirm classification through the Medical Device Classification resource.
Plan your budget accounting for fees, testing, and consultancy costs.
Register and submit your initial test license application (Form MD13) via the CDSCO MD Online Portal.
Engage with CDSCO-approved testing labs promptly to schedule product testing.
Prepare comprehensive technical and quality documentation including Device and Plant Master Files.
Select and coordinate with a notified body for the mandatory audit.
Submit your manufacturing license application (Form MD3) after successful test reports and audit.
Starting early and ensuring thorough preparation significantly increases the chances of a smooth and timely CDSCO license grant.
For personalized assistance tailored to your periocular/lacrimal retractor or other ophthalmic devices, contact our regulatory experts today and leverage our 25+ years of proven expertise to fast-track your CDSCO licensing journey.
