CDSCO License for Ophthalmic tonometer, battery- operated

Introduction to Ophthalmic Tonometer Regulatory Compliance

Ophthalmic tonometers are critical medical devices used to measure intraocular pressure (IOP), an essential parameter in diagnosing and managing glaucoma and other ocular conditions. The battery-operated, handheld tonometer, such as the Perkins tonometer, is designed for versatile use—including postoperative, bedridden, and pediatric patients—offering mobility and ease of use in various clinical settings. Given its intended use in pediatrics and neonatology, and the fact that it exerts an external force on the eye, this device is classified as a Class B medical device under the Indian CDSCO framework.

Navigating the regulatory landscape for such devices is crucial for manufacturers and importers aiming to establish or expand their market presence in India. The Central Drugs Standard Control Organization (CDSCO) governs medical device registration, licensing, and post-market surveillance to ensure safety, efficacy, and quality.

CDSCO Regulatory Framework for Battery-Operated Ophthalmic Tonometers

The CDSCO classifies medical devices into four risk-based categories: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). Our device falls under Class B, which requires a manufacturing license (MD5) issued by the State Licensing Authority and an import license (MD15) granted by the Central Licensing Authority for imported devices.

This device is governed by the Medical Device Rules, 2017, and must comply with essential principles including safety, performance, and labelling requirements. The official notification for the ophthalmic tonometer (File No. 29/MiscJ03/2020-DC (150), dated 23.08.2021) confirms its categorization and regulatory obligations.

Risk Classification and License Requirements for Ophthalmic Tonometer

Risk Class: B (Low-Moderate Risk)
Manufacturing License: MD5 (Application Form MD3)
Import License: MD15 (Application Form MD14)
Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import
Total Processing Time:
- Manufacturing License: 3-4 months
- Import License: 5-6 months

Manufacturing License Process for Class B Device (MD5)

For manufacturers of battery-operated ophthalmic tonometers, the CDSCO mandates the following sequential process:

Test License Application (Form MD13): The manufacturer must first apply for a test license, which requires about 1.5 to 2 months for approval.
Product Testing: Following test license approval, the product must undergo testing at CDSCO-approved testing laboratories to verify compliance with Indian and international standards. Refer to the list of Testing Laboratories for authorized labs.
Document Preparation: Compile the required documentation, including technical files, risk management reports, and quality management system (QMS) certifications.
Manufacturing License Application (Form MD3): Submit the application for an MD5 license via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body approved by CDSCO. Check the list of notified bodies to select an auditor.
Query Resolution: Address any queries raised by the CDSCO or the notified body.
Grant of License (Form MD5): Upon satisfactory review, the manufacturing license is granted.

Manufacturing License Documents Required

Manufacturers must prepare and submit comprehensive documentation, including:

Company Constitution and incorporation documents
Proof of ownership or lease of manufacturing premises
Qualification and experience certificates of technical staff
No Objection Certificates (NOCs) for fire and pollution control
Device Master File detailing design, specifications, and manufacturing processes (Device Master File Guide)
Plant Master File describing the manufacturing facility (Plant Master File Guide)
Essential Principles Checklist ensuring compliance with safety and performance standards
Risk Management File based on ISO 14971 principles (Risk Management Guide)
Test Reports from CDSCO-approved labs
Product labels and Instructions for Use (IFU) with required declarations
Quality Management System (QMS) documentation, ideally ISO 13485:2016 certified

Import License Process for Ophthalmic Tonometer (MD15)

Importers of battery-operated ophthalmic tonometers must follow a distinct procedure governed by the Central Licensing Authority:

Document Preparation: Ensure all required certificates and technical documentation are ready.
License Application (Form MD14): Submit the MD15 import license application through the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any CDSCO queries.
Grant of License (Form MD15): Upon compliance verification, the import license is granted.

Notably, a test license is not required for import applications.

Import License Documents Required

Key documents to be submitted include:

Valid manufacturing license from the country of origin
Free Sale Certificate or Certificate to Foreign Government
ISO 13485:2016 certification
CE Certificate or equivalent international conformity declaration
Device Master File and Plant Master File
Wholesale license (if applicable)
Company Constitution and incorporation documents

Timeline and Processing Duration

License Type	Timeline
Test License (MD13)	1.5 to 2 months
Manufacturing License (MD5)	3 to 4 months (including test license, testing, audit)
Import License (MD15)	5 to 6 months

Manufacturers should anticipate the entire MD5 licensing process to take approximately 3-4 months, factoring in audit and testing delays. Importers must plan for 5-6 months due to additional document scrutiny.

Government Fees and Costs

For the ophthalmic tonometer under Class B:

MD5 Manufacturing License:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
MD15 Import License:
- Site Fee: $2,000
- Per Product Fee: $1,000

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Practical Solutions

Challenge 1: Delayed Test Reports

Solution: Engage with accredited labs early to schedule testing. Use the CDSCO Testing Laboratories list to select labs with shortest turnaround times.

Challenge 2: Audit Non-Compliance

Solution: Conduct internal mock audits using the Notified Bodies list requirements as benchmarks. Ensure your QMS and Plant Master File are audit-ready.

Challenge 3: Incomplete Documentation

Solution: Follow comprehensive guides like the Device Master File Guide and Plant Master File Guide to prepare robust dossiers.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO queries, avoiding unnecessary delays.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ companies in successful CDSCO licensing, we provide end-to-end support including:

Gap analysis of your current documentation and QMS
Preparation and submission of test license (MD13) and manufacturing license (MD5) applications
Coordination with notified bodies and testing laboratories
Post-approval compliance and renewals guidance

Our expert consultants stay updated with the latest CDSCO notifications and can streamline your regulatory journey.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your ophthalmic tonometer is Class B using Medical Device Classification.
Prepare Your Technical and Regulatory Documentation: Start compiling your Device Master File, Plant Master File, risk management file, and other essential documents.
Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to initiate testing procedures.
Engage a Notified Body for Audits: Select and schedule an audit with a notified body listed on the CDSCO portal.
Coordinate Product Testing: Partner with CDSCO-approved labs early to avoid delays.
Submit Manufacturing License Application (MD3): Once test reports and audits are complete.
Prepare for Query Responses: Have your regulatory team ready to respond swiftly to any CDSCO queries.

By following these actionable steps and leveraging our decades of expertise, manufacturers and importers of battery-operated ophthalmic tonometers can efficiently navigate the CDSCO licensing process and successfully enter the Indian market.

For detailed guidance, please consult our MD5 License Guide and Import License Guide.

CDSCO License for Ophthalmic tonometer, battery- operated

Medical Device Information

Intended Use