Mandatory CDSCO License for Ophthalmology Products in India
Ophthalmology Products, comprising a comprehensive spectrum of specialized devices and tools essential for eye care and vision-related treatments, are subject to regulatory oversight in India under the Medical Devices Rules, 2017. This category encompasses a wide array of products, including surgical instruments, diagnostic equipment such as ophthalmoscopes and refractometers, contact lenses, and intraocular lenses used in cataract surgery, among others.
As of September 2023, the Central Drugs Standard Control Organization (CDSCO) mandates the possession of a valid license for any entity involved in the manufacturing, importation, sale, or distribution of ophthalmology products within India.
Licensing authorities for Ophthalmology Products in India
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Class C and Class D Ophthalmology products and the State Licensing Authority is the licensing authority for Class A and Class B Ophthalmology Products in India.
List of “Class A” Ophthalmology Products
- Amsler grid
- Anomaloscope
- Automated lensmeter(Dioptometer)
- Bagolini lens
- Binocular vision test unit
- An ophthalmic device for binocular vision testing.
- Blepharoplasty scissors
- Colour discrimination tester
- Colour-discrimination eye chart
- Conjunctival scissors
- Contact lens radius gauge
- Diagnostic condensing lens
- Eikonometer
- Electronic occlusion spectacles
- Enucleation scissors
- Euthyscope
- Exophthalmometer
- Eye cup
- Eye irrigation shield
- Eye pad
- Eye spud
- Eyelid clamp
- Eyelid weight, external
- Felt tangent screen
- Fibreoptic general-purpose ophthalmic hook
- Flieringa ophthalmic ring
- Fornixscope
- Fresnel lens
- Fresnel prism
- Haidinger brush imager
- Hand-held campimeter
- Hand-held telescope
- Indirect binocular ophthalmoscope
- Lens spoon
- Maddox trial lens
- Mirror-prism spectacles
- Nystagmus inducing optokinetic drum
- Nystagmus inducing tape
- Ophthalmic caliper
- Ophthalmic distometer
- Ophthalmic head reflector
- Ophthalmic operating table top
- Ophthalmic surgical device handling forceps
- Ophthalmic suture scissors
- Ophthalmodiastimeter
- Ophthalmoleukoscope
- Optical pachymeter
- Orbital depressor
- Perimeter
- Periocular/lacrimal retractor
- Phorometer
- Phoropter
- Pleoptophor
- Polatest
- Pupillograph
- Pupillometer
- Sclerotome
- Scotometer
- Surgical binoculars
- Synoptophor
- Tachistoscope
- Visual chart
- Visual light box
- Visual projector
- Visual evoked-potential electrode
- Contact Lens Inserter/Remover
List of “Class B” Ophthalmology Products
- Adaptometer
- Contact Lens (Including Coloured Contact Lens)
- Contact lens agitation cleaning system
- Contact lens disinfecting solution
- Contact lens protein-removal solution
- Contact lens thermal cleaner
- Corneal burr manual instrument
- Corneal burr system
- Corneal burr, abrasion
- Corneal burr, rust ring removal
- Corneal epithelium perforator
- Corneal epithelium trephine
- Corneal light shield
- Corneal marker
- Corneal resection holder
- Corneal scissors
- Corneoscleral punch
- Epiretinal/inner limiting membrane scraper
- Eye heat therapy pack
- Eye muscle clamp
- Keratome
- Ophthalmic Irrigation Solution (Balanced Salt Solution)
- Ophthalmic soft-tissue surgical forceps
- Ophthalmic tonometer
- Ophthalmic ultrasound imaging system
- Ophthalmoscope
- Scleral marker
- Ultrasound pachymeter
- Intraocular lens guide
- Ophthalmic refractometer
- Keratoscope
List of “Class C” Ophthalmology Products
- Capsular bag anchor
- Corneal inlay, aperture reducing
- Corneal inlay, cornea-reshaping
- Donor cornea container
- Endoscopic-imaging ophthalmic solid-state laser system
- Eye muscle sleeve
- Eye valve
- Eyelid weight, implantable
- Femtosecond ophthalmic solid-state laser system
- Fundus-imaging ophthalmic diode laser system
- Fundus-imaging ophthalmic solid-state laser system
- Glaucoma supraciliary implant
- Glaucoma therapy ultrasound system
- Implantable intraocular pressure monitoring system
- Implantable iris prosthesis
- Intracorneal ring
- Intranasal lacrimal neurostimulator
- Lacrimal tube
- Ophthalmic clip
- Ophthalmic cryosurgical system
- Ophthalmic dye laser system
- Ophthalmic excimer laser system
- Ophthalmic noble gas laser system
- Orbital rim prosthesis
- Phacoemulsification system
- Ptosis sling
- Retinal tack
- Scleral buckling device
- Scleral expansion implant
- Symblepharon ring
- Vitrectomy system
- Vitreous body prosthesis
- Intraocular fluid
List of “Class D” Ophthalmology Products
- Aqueous/vitreous humour replacement medium kit
Are You Looking for CDSCO License to Manufacture and Import Ophthalmology Products in India?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
Ophthalmology Products Licensing Requirement:
- To manufacture Class A and Class B Ophthalmology products in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C Ophthalmology products in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import Ophthalmology products into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for Manufacturing, Importing, and Distributing Ophthalmology Products in India
- Class A and Class B devices: MD 5 License from the State Licensing Authority
- Class C devices: MD 9 License from the CDSCO
- Import: MD 15 Import License from the CDSCO
License Fee for Ophthalmology Products in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of Ophthalmology Products License in India
Ophthalmology product licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for Ophthalmology Products Manufacturing or Import License in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining Ophthalmology Products License in India
The deadline for obtaining Ophthalmology products license in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining an Ophthalmology Products Manufacturing License in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.
