Ophthalmic medical devices play a critical role in diagnosis, treatment, monitoring, and surgical management of eye-related diseases and vision disorders. Given their role in healthcare industries, regulatory bodies regulate ophthalmic medical devices to ensure product safety, performance, and patient protection. Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices, cosmetics, and pharmaceuticals in India. This apex body monitors and regulates all ophthalmic medical devices marketed in India. As per CDSCO regulations, CDSCO licensing for ophthalmic medical devices in India is mandatory. Given the impact and demand for this medical device in the Indian market, CDSCO strictly regulates its safety, quality, and efficacy. CDSCO regulations for ophthalmic medical devices ensure substandard and inferior quality machines do not enter the Indian market. In this blog, we will focus on how to obtain CDSCO license for Class C and D ophthalmic medical devices.
What are ophthalmic medical devices?
Ophthalmic medical devices are specialized instruments, equipment, and implants designed by biomedical engineers to diagnose, monitor, and treat vision disorders and diseases of the eye. These technologies range from non-invasive diagnostic tools, like slit lamps and optical coherence tomography (OCT) scanners, that visualize ocular structures to advanced surgical systems, such as excimer lasers for vision correction and phacoemulsification machines for cataract removal. They also include implantable hardware, such as intraocular lenses (IOLs). Additionally, microscopic glaucoma drainage stents are also examples of ophthalmic medical devices that are engineered to preserve, restore, or enhance human vision. Owing to their role, ophthalmic medical devices have to be regulated for the following reasons:
- Patient safety
- Accuracy of diagnostics
- Biocompatibility verification
- Cybersecurity and data privacy
- Surgical precision
- Post-market surveillance
CDSCO medical device classification for ophthalmic medical devices
For the ease of CDSCO registration, CDSCO has categorised medical devices into four classes. In the ascending order of risk level, Class A, B, C, and D are the four CDSCO medical device classes. The CDSCO license required and the application process will depend on the CDSCO risk class. Similar to other medical devices, ophthalmic medical devices have been categorised into four classes, namely A, B, C, and D. In this blog, we will focus only on Class C and D ophthalmic medical devices.
- Class C ophthalmic medical devices: Moderate to high-risk medical devices are grouped as class C. They require stricter regulatory oversight than other medical devices. Examples: capsular bag anchor, corneal inlay (aperture reducing), femtosecond ophthalmic solid-state laser system, vitrectomy system.
- Class D ophthalmic medical devices: High-risk medical devices are grouped as class D. They require the maximum regulatory scrutiny due to their critical medical applications. Examples: aqueous/vitreous humour replacement medium kit.
CDSCO license for Class C and D ophthalmic medical devices
The CDSCO class for ophthalmic medical devices will determine the license and application process required.
- Manufacturing license: Entities seeking to obtain a license for manufacturing ophthalmic medical devices in India need to apply using the Form MD-7. Application has to be filed online and pay the necessary processing fee. Medical device regulatory officers will inspect the production facility within 60 days from the date of application. The regulatory body will relay the approval via Form MD-9. This will permit the manufacturing company to manufacture, sell, and distribute ophthalmic medical devices in India.
- Loan license: A loan license can be used to manufacture medical devices when the manufacturer does not own a manufacturing facility. Manufacturers seeking to obtain a loan license for manufacturing ophthalmic medical devices in India need to apply using the Form MD-8. The medical device manufacturer has to apply online and pay the necessary processing fee. Medical device regulatory officers will inspect the production facility within 60 days from the date of application. The regulatory body will relay the approval via Form MD-10. This will permit the manufacturer to manufacture, sell, and distribute ophthalmic medical devices in India with a loan license.
Documents required for securing the CDSCO license for Class C and D ophthalmic medical devices
- Constitution proof (GST Certificate / CIN / MOA AOA)
- Cover letter
- Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
- Sale Deed/Rent Deed proving legal ownership of the manufacturing facility.
- Plant master file
- Device master file
- ISO 13485 Certificate
- Certificate of analysis of 3 consecutive batches
- Fire and Pollution NOCs
- Post marketing surveillance data
- Manufacturing facility building layout presenting the dimensions of each room and the location of all the equipment in the facility.
- Documents proving the manufacturing team comprises competent, qualified, and experienced staff.
- Test license (if applicable)
- In case of loan license application, consent letter from the principal manufacturing unit, principal manufacturer’s license and product permit, and wholesale license of the applicant.
We have provided an overview of the documents required for securing CDSCO license for Class C and D ophthalmic medical devices. To avail our comprehensive document preparation service, feel free to reach out to us. Our team will prepare all the necessary supporting documents per CDSCO guidelines. We will ensure the documents align perfectly with CDSCO requirements.
Step-by-step guide to secure the CDSCO license for Class C and D ophthalmic medical devices
- Applicant registration: Sign in or login to CDSCO online registration portal, SUGAM.
- Form filling: Fill the MD7 application form. Details, such as device’s classification, brand name, intended use, and a detailed product description, will be required.
- Document submission: Prepare and upload essential supporting documents required for license application. This will include ISO 13485 certificate, Plant Master File, Device Master File, organisation details etc.
- Fee payment: Pay the necessary CDSCO license application fee, which will depend on the device’s classification.
- Application confirmation: Once all documents are submitted and fees are paid, you will receive an application number. This will confirm successful submission.
- Application review: CDSCO will meticulously review the application and all attached documents.
- CDSCO queries: If there are queries or discrepancies, CDSCO will reach out for clarification or additional information.
- Query response: CDSCO queries have to be promptly and accurately addressed. Submit any requested justifications or revised documents through the portal.
- Facility audit and inspection: CDSCO officials will audit your factory for regulatory compliance.
- Final review: CDSCO will once again review the application and documents. If everything aligns with the regulations, the officials will move forward with the application.
- License grant: Once all criteria are satisfied and queries are responded, the CDSCO MD9 license for Class C and D ophthalmic medical devices will be granted.
How can Pharmadocx Consultants help you secure the CDSCO license for ophthalmic medical devices?
With over 27 years of experience and having served more than 600 clients, we have in-depth knowledge of CDSCO regulations. Let us make the arduous CDSCO medical device licensing process hassle free for you. Pharmadocx Consultants can make the CDSCO registration process a breeze for you so that you can focus on establishing your business. Our service covers:
- Document preparation
- License application
- Mock audit
- Query response
- Post license support
- End-to-end assistance
At Pharmadocx Consultants, our clients are our top priority. We tailor our services to meet your specific needs, ensuring a personalized experience. Backed by years of experience, our license application process is streamlined and time-efficient. We offer cost-effective comprehensive client-centric services. Simply call/Whatsapp us at 9996859227 or drop an email at [email protected] to easily secure your CDSCO license for Class C and D ophthalmic medical devices.
