Introduction to Ophthalmic Medical Devices
Ophthalmic medical devices are specialized tools and equipment used in the field of eye care to diagnose, treat, and monitor various eye conditions and vision problems. These devices encompass a diverse range of technologies that aid ophthalmologists and eye care professionals in providing accurate assessments and effective treatments for patients. From diagnostic devices that examine the interior structures of the eye to surgical instruments used in intricate procedures, ophthalmic medical devices play a pivotal role in maintaining and improving eye health and visual acuity.
Ophthalmic medical devices include instruments like ophthalmoscopes, slit lamp biomicroscopes, and refractive tools, all of which serve vital roles in diagnosing and treating eye conditions.
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Information About an Update on Compulsory Registration for Class C and Class D Medical Devices
Starting from October 1, 2023, Class C and Class D medical devices, which were previously required to be registered, will now need to follow a licensing regime as per the recent circular issued by the Central Drugs Standard Control Organization (CDSCO) on April 12, 2023. This transition aligns with GSR 102(E) dated February 11, 2020.
Manufacturers and importers seeking a manufacturing or import license for these devices should apply online via the CDSCO portal. The application process must include necessary documents and fees, following the guidelines of the Medical Devices Rules (MDR) 2017.
List of Class C and D Ophthalmic Medical Devices
List of Class C and D Ophthalmic Medical Devices
Have a look at some of the Class C and D Ophthalmic Medical Devices listed below
Sr. No. | Device Name | Risk Class |
1. | Capsular bag anchor | C |
2. | Corneal inlay, aperture reducing | C |
3. | Femtosecond ophthalmic solid-state laser system | C |
4. | Vitrectomy system | C |
5. | Aqueous/vitreous humour replacement medium kit | D |
Refer to this for A detailed Classification of Medical Devices Pertaining to Ophthalmology.
Documents Required for CDSCO Manufacturing License of Class C and Class D Opthalmic Medical Devices
Gaining a CDSCO manufacturing license from CDSCO entails a holistic commitment to compliance, covering meticulous facility standards, methodical protocols, and exhaustive documentation. This unwavering approach guarantees the creation of medical devices that uphold rigorous benchmarks for quality and safety.
Documents Required for CDSCO Import License of Class C and Class D Opthalmic Medical Devices
Securing a CDSCO import license necessitates obtaining Approval and Free Sale Certificates from recognized global regulatory bodies like the USA, EU, Japan, Australia, and Canada. These certificates affirm compliance with international quality standards and unrestricted market approval, underscoring their vital role in upholding safety and import quality.
How can Operon Strategist Help you with CDSCO Registration for Class C and Class D Ophthalmic Medical devices?
Discover a seamless path to Class C and D Ophthalmic Medical Devices Registration by connecting with Operon Strategist. Our seasoned experts are dedicated to guiding you through the intricate regulatory landscape. With a proven track record of successful registrations, we ensure meticulous attention to detail and adherence to industry requirements. Let us navigate the complexities while you focus on innovation. Reach out to Operon Strategist today and embark on your journey towards swift and compliant registration for Class C and D Ophthalmic Medical Devices. Your success is our commitment.
Seeking a Class C and D Ophthalmic Medical Devices Registration CDSCO Manufacturing or CDSCO Import Licence? Contact us Today!
