Ophthalmic devices, pivotal in diagnosing and treating eye-related conditions, are subject to rigorous regulatory standards in India. Central Drugs Standard Control Organization (CDSCO) regulates all medical devices entering the healthcare market. Similar to all other medical devices, ophthalmic devices are subject to stringent regulations. These regulations are required to prevent substandard medical devices from entering the Indian market. Thus, ophthalmic manufacturers and importers are required to abide by the regulatory protocols. Furthermore, they are required to mandatorily secure the CDSCO ophthalmic medical device license. In this guide, we will focus on CDSCO ophthalmic medical devices registration.

Understanding CDSCO Ophthalmic Medical Device Classification

Medical devices are categorized based on the potential risks associated with their use. Understanding the medical device classification system is the first step in CDSCO medical device license application.  

Ophthalmic devices play a vital role in ensuring precise diagnosis and effective treatment of ophthalmic conditions. Hence, they have to be stringently regulated in India. Thus, securing a CDSCO ophthalmic medical device license is mandatory for importing/manufacturing these devices. The CDSCO medical device classification system has been developed to simplify the license application process. Use our free tool to check which CDSCO class your device belongs to.

Ophthalmic medical device classes

We have listed few examples of medical devices belonging to each CDSCO class. This CDSCO medical device classification system helps ease out the ophthalmic medical devices registration process.

CDSCO class A:

• 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
• Scotometer
• Surgical binoculars
• Synoptophor
• Tachistoscope
• Visual chart
• Visual light box
• Visual projector
• Visual evoked-potential electrode
• Contact Lens Inserter/Remover
• 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
• 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

CDSCO class B:

• Corneal burr, abrasion
• Corneal burr, rust ring removal
• Corneal epithelium perforator
• Corneal epithelium trephine
• Corneal light shield
• Corneal marker
• Corneal resection holder
• Corneal scissors
• Ophthalmic tonometer
• Ophthalmic ultrasound imaging system
• Ophthalmoscope
• Scleral marker
• Ultrasound pachymeter
• Intraocular lens guide
• Ophthalmic refractometer
• Keratoscope
• Epiretinal/inner limiting membrane scraper
• Eye heat therapy pack
• Eye muscle clamp
• Keratome

Class C:

• 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
• 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
• Intracorneal ring
• Intranasal lacrimal neurostimulator
• Lacrimal tube
• Ophthalmic clip

CDSCO class D:

• Aqueous/vitreous humour replacement medium kit

New Guidelines for Ophthalmic Medical Devices Registration

CDSCO, in its pursuit of ensuring patient safety and product efficacy, has refined its guidelines. For Class C and Class D ophthalmic devices, the emphasis is on thorough testing, quality assurance, and adherence to international standards.

The Deadline: Key Dates to Remember for Ophthalmic Medical Devices Registration and Licensing

CDSCO has transitioned Class C and Class D ophthalmic devices from the mandatory registration mechanism to a licensing structure. This has been detailed in GSR 102(E) dated 11.02.2020. Notably, this significant shift will be in effect from October 1, 2023. For a more in-depth understanding of the ophthalmic medical devices registration process, the official CDSCO circular is an invaluable reference.

CDSCO Ophthalmic Medical Devices Registration Process

Regulatory compliance is a testament of the manufacturer’s commitment to patient safety and product quality. Furthermore, ensuring adherence not only fosters trust but also solidifies the brand’s reputation in the market. Thus, securing the CDSCO license is more than a regulatory requirement. It establishes the brand’s identity in the market. However, navigating through the CDSCO medical device license application process can be tricky. Hence, we have prepared this guide to help you.

CDSCO Ophthalmic Medical Devices Registration: License Types

• Manufacturing class A and B ophthalmic medical devices: MD 5 License is required. Moreover, a fee of Rs. 5,000 for the manufacturing license and Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D ophthalmic medical devices: MD 9 License is required.Furthermore, a fee of Rs. 50,000 for the manufacturing license and Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing ophthalmic medical devices into India: MD 15 Import License has to be secured from the CDSCO to import ophthalmic medical devices into India.

Documents Required for CDSCO Ophthalmic Medical Devices Registration

We have provided an overview of the documents required for securing the CDSCO ophthalmic medical device license.

1. Plant Master File
2. Building Layout with Dimension
3. Organization identity proof
4. Sale Deed/Rent Deed of the Premises
5. Device Master File
6. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
7. Test License, if required for testing the ophthalmic medical device
8. Environmental regulation compliance documents
9. ISO 13485 Certificate
10. Certificate of analysis of 3 consecutive batches

A Step-by-step Guide for CDSCO Ophthalmic Medical Devices Registration Process

The CDSCO registration trajectory for ophthalmic devices is as follows:

• Documentation: Collating all necessary documents, including clinical trial data and product specifications.
• Application Submission: The application has to be filed online on CDSCO’s official online portal, SUGAM.
• Query Resolution: Any queries raised by CDSCO has to be addressed promptly.
• Inspection: You have to prepare for the CDSCO inspection and audit phase.
• License Approval: Once all criteria are met, CDSCO will grant the license.

Validity of the CDSCO Ophthalmic Medical Device License

CDSCO ophthalmic medical device license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

Common CDSCO Ophthalmic Medical Devices Registration Challenges and How to Overcome Them

Manufacturers and importers might encounter the following challenges while applying for the CDSCO ophthalmic medical device license. Thus, we have listed some strategies to overcome them.

• Documentation Gaps: Ensuring all documents are current and meet CDSCO’s standards.
• Delays in Query Resolution: Establishing a dedicated team to address CDSCO queries swiftly.
• Inspection Hurdles: Conducting regular internal audits of facilities to ensure they align with CDSCO guidelines.

How Can Pharmadocx Consultants Help You Secure the CDSCO Ophthalmic Medical Device License?

Pharmadocx Consultants offers a suite of services tailored for ophthalmic device manufacturers:

• Expert Guidance: Assistance throughout the registration journey.
• Mock Audits: Conducting pre-inspection audits to ensure readiness.
• Query Resolution: Swiftly addressing CDSCO queries.
• End-to-End Support: Comprehensive support from the initial application to license approval.

The mandatory CDSCO ophthalmic devices licensing ensures that healthcare professionals are equipped with state-of-the-art tools for eye care. With the help of seasoned partners like Pharmadocx Consultants, the CDSCO licensing pathway will become smooth and efficient. Seeking expert guidance for CDSCO ophthalmic medical devices registration? Contact Pharmadocx Consultants today!