What are Ophthalmic Devices?
In simple language the medical devices used in optometry and ophthalmology are termed as Ophthalmic devices. The examples of Opthalmic devices are contact lenses, intraocular lenses, glaucoma stents. Ophthalmology is a branch which deals with the structure, function and various eye diseases. Ophthalmic devices are medical equipment designed for the diagnosis and vision correction.
List of few medical devices used in ophthalmology:
- Contact lenses
- Vision screener
- Lasers
- Surgical instruments
- Intraocular lenses
What Is the Manufacturing and Regulatory Process for Ophthalmic Devices?
It’s always fascinating to watch or research how things are made; if we specifically talk about Opthalmic lenses in some basic 3 steps semi furnished lenses are made as casting, Injection Moulding, specialized rim injection Moulding. We have highly trained professionals who work with ophthalmic device manufacturers who specialize in a variety of fields like cataract surgery and refractive correction etc.
What Are the Compliances and Regulatory Approvals Required for Ophthalmic Devices?
As an ophthalmic device manufacturer, you must ensure that you meet the necessary regulatory requirements before placing your ophthalmic device onto the market.
Manufacturer of Ophthalmic devices in India need to apply for CDSCO registration and should obtain CDSCO manufacturing license. To obtain this license one need to classify their device as per the latest notification. The CDSCO issued clarity on the classification of medical devices.
Once the product is manufactured, the manufacturer can simultaneously apply for various other countries for product approvals. If you are placing your medical device in the EU market then you must comply with EU MDR and should affix a CE mark for medical devices Similarly, to place the market in various countries, their respective regulatory approvals are required.
Global Ophthalmic Device Market Size
The Global Ophthalmic Devices Market size is expected to reach USD 33.99 billion by 2026. (Source; Global Newswire data) Medical companies, distributors, manufacturers are putting efforts to introduce new ophthalmic devices to the market. These devices are used to treat various eye conditions and infections. Advancement in technology and aging population are the driving factors for this market.
Indian Scenario: As per the few reports’ ophthalmology-based diseases are increasing in India. (by the Grand view research report) The India ophthalmic devices market is segmented as surgical devices, vision care devices diagnostic devices. The huge growth is expected in Indian ophthalmic device market in near future. Major contributing factors for the growth of this market are:
- Geriatric population.
- Increasing cases of vision loss and eye disease
- Introduction of novel products with the use of advanced technology.
Ready to Navigate the World of Ophthalmic Device Manufacturing and Compliance?
What is Our Role in Ophthalmic Devices Manufacturing?
We provide solution and know-how for the below areas:
- Product and Process Technology:
- Manufacturing Facility and Infrastructural requirements
- Overall regulatory approval and Turnkey Services.
As a medical device regulatory consultant We understand the challenges faced by the manufacturer, for implantable devices, so our highly experienced team focuses on providing guidance on regulatory aspect of ophthalmic devices so that the manufacturers can easily bring their products onto the market. For more than12 years we are providing regulatory assistance to national as well as international device makers and suppliers. For any regulatory approval or for any query you can easily reach to us.
MBA Finance, Science graduate, SEO & Technical content writer, possesses keen research and influencing writing skills for more than a year.
