At AccordMed Consultants, we understand the intricate regulatory requirements for importing and manufacturing ophthalmology products in India. Whether you deal in diagnostic devices, surgical instruments, or therapeutic ophthalmic products, obtaining the mandatory CDSCO license is critical to entering the Indian market.
Here’s everything you need to know about the CDSCO license process for ophthalmology products:
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority overseeing medical devices and drugs in India. Ophthalmology products are classified as medical devices and are regulated under the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940.
The CDSCO ensures that all ophthalmology products comply with safety, quality, and performance standards before they are marketed or distributed in India.
Classification of Ophthalmology Products
Ophthalmology products are categorized into four risk-based classes under the Medical Devices Rules, 2017:
- Class A: Low Risk (e.g., eye patches, diagnostic strips)
- Class B: Low to Moderate Risk (e.g., handheld tonometers, slit lamps)
- Class C: Moderate to High Risk (e.g., intraocular lenses, ophthalmic lasers)
- Class D: High Risk (e.g., corneal implants, vitreoretinal prostheses)
Higher-risk devices require a more rigorous review process by the CDSCO, ensuring that products meet international safety and efficacy standards.
Steps to Obtain the CDSCO License for Ophthalmology Products
- Determine Device Classification
Accurately classify your ophthalmology product (Class A, B, C, or D) based on its risk level and intended use. This classification determines the licensing process and documentation required.
- Appoint an Indian Authorized Agent (IAA)
Foreign manufacturers must appoint an Indian Authorized Agent (IAA) to act as their local representative for compliance and regulatory submissions.
- Register the Product
For importers, product registration is mandatory. Submit detailed documentation, including technical specifications, clinical data, and proof of compliance with applicable standards. The registration process culminates in obtaining an Import License MD 15.
- Manufacturing License
If manufacturing ophthalmology products in India, you must obtain a Manufacturing License (Form MD-9 or Form MD-5) from the CDSCO or SLA. This involves compliance inspections and facility audits.
- Adhere to Labeling Standards
Ensure that the product labeling complies with Indian regulations, including:
- Manufacturer and importer details.
- Manufacturing and expiry dates.
- CDSCO registration/license number.
- Usage instructions and safety warnings.
- Post-Market Surveillance
After licensing, manufacturers and importers must comply with post-market requirements such as:
- Reporting adverse events to the CDSCO.
- Maintaining distribution records.
- Cooperating with periodic audits and inspections.
- Relaxation to Class A Non-Sterile Non-Measuring Devices (Low risk devices)
Relaxation is provided by the CDSCO for import of Class A NSNM devices. These are relaxed from the stringent requirements as compared to other devices. Such low risk devices are needed to be registered with CDSCO as per GSR 777(E).
Why is the CDSCO License Mandatory for Ophthalmology Products?
The CDSCO license ensures:
- Patient safety and access to high-quality products.
- Alignment with global regulatory standards.
- Prevention of substandard or counterfeit products in the market.
How Can AccordMed Consultants Help?
Navigating India’s regulatory landscape can be challenging, but AccordMed Consultants is here to simplify the process for you. Our end-to-end services include:
- Determining device classification and compliance requirements.
- Preparing and submitting the CDSCO application.
- Assisting with clinical data and technical documentation.
- Liaising with regulatory authorities for approvals.
- Managing post-market compliance and renewals.
With our expert guidance, you can focus on delivering cutting-edge ophthalmology products while we handle the regulatory complexities.
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Ready to bring your ophthalmology products to the Indian market? Contact AccordMed Consultants today for a personalized consultation and let us streamline your CDSCO licensing process.
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Frequently Asked Questions
Mandatory CDSCO License and Import License MD 15 for Ophthalmology Products in India
The Central Drugs Standard Control Organization (CDSCO) is India’s regulatory body for drugs and medical devices. A CDSCO license ensures that ophthalmology products meet safety, quality, and performance standards before entering the Indian market.
All ophthalmology products classified as medical devices under the Medical Devices Rules, 2017 require a CDSCO license. These include:
- Diagnostic tools (e.g., tonometers, slit lamps).
- Therapeutic devices (e.g., intraocular lenses, corneal implants).
- Surgical instruments (e.g., ophthalmic lasers, vitreoretinal prostheses).
Ophthalmology products are classified into four risk-based categories:
- Class A: Low Risk (e.g., diagnostic strips).
- Class B: Low to Moderate Risk (e.g., handheld tonometers).
- Class C: Moderate to High Risk (e.g., intraocular lenses).
- Class D: High Risk (e.g., corneal implants).
The classification determines the level of scrutiny and the approval process required by CDSCO.
Key documents include:
- Device classification details.
- Technical specifications and performance data.
- Clinical evaluation data.
- Certificate of compliance with applicable standards (e.g., ISO 13485).
- Details of the manufacturer and importer.
An Indian Authorized Agent (IAA) is a legal representative for foreign manufacturers in India. The IAA handles regulatory submissions, compliance, and liaison with the CDSCO on behalf of the manufacturer.
What is the process for obtaining a CDSCO license for imported ophthalmology products?
The process involves:
- Determining the classification of the device.
- Submitting an application with required documentation.
- Undergoing technical and regulatory reviews.
- Obtaining an Import License (Form MD-15).
Yes, low-risk devices (Class A) require simpler registration processes, while high-risk devices (Class C and D) undergo rigorous reviews, including clinical data evaluation and inspections.
The timeline depends on the product’s classification and complexity. Low-risk devices may be approved faster (within weeks), while high-risk devices can take several months.
Marketing unlicensed products can lead to penalties, product recalls, and import bans. Compliance with CDSCO regulations is mandatory to avoid legal and financial risks.
At AccordMed Consultants, we offer:
- Expert guidance on device classification and compliance.
- Assistance with documentation and application submission.
- Liaison with CDSCO and regulatory authorities.
- Post-approval compliance management.
We simplify the licensing process, ensuring that your ophthalmology products reach the Indian market efficiently and legally.
