India is fast becoming one of the strongest players in the
healthcare sector. Many factors contribute to India's status as a hub for
affordable healthcare and creative medical research and development. The
Government of India has established the Central Drug Standards Control
Organization (CDSCO) as the legislative and regulatory body for the control and
control of medical devices and drugs in India. The Directorate General of Drug
Administration (DCGI) of India directs his CDSCO and licenses are granted by
either the State Licensing Authority or the Central Licensing Authority based
on the inherent risks of the medical device.
In India, the Pharmaceuticals and Cosmetics Act, of 1940
regulates the sale, distribution, manufacture, import, and export of medical
devices. Medical and in-vitro diagnostic devices are required to obtain
mandatory CDSCO approval before being marketed in India under the Medicines and
Cosmetics Act, of 1940. Scroll down to learn more about his CDSCO registration
for ophthalmic medical devices.
What is a medical device?
Under the updated definition under the Medical Devices
Amendment Regulations 2020, notified on February 11, 2020, the Government is
using its powers to expand the definition of “medical device” under the Act to:
add a new category. It reads: "Devices used in general medical practice,
such as medical apparatus, instruments, implants, appliances, etc., used
individually or in combination and intended to be specifically applied for
humans or animals and further intended to obtain the desired function by such
means and for such purposes, as provided below, are not intended to have its
primary intended effect on humans or animals by pharmacological means.
- Analyzing, preventing, monitoring, treating, or
alleviating a disease or disorder
- Analyzing,
monitoring, treating, mitigating, or assisting with injury or
- Investigate, replace, modify or support anatomical or
physiological findings
- To sustain or sustain life • Decontamination of medical
devices
- Fertility-related and medical devices.
For registration
purposes, medical devices are divided into two categories: “registered devices”
and “unregistered devices”. CDSCO regulates 37 notified medical devices.
What are ophthalmic
medical devices?
Ophthalmic medical devices are used in ophthalmology and
optometry and include invasive, non-invasive, and implantable devices that aid
in vision correction, surgery, and diagnosis of various eye diseases. Under the
Drugs and Cosmetics Act 1940 and the Medical Devices Regulations 2017, there
are approximately 100 ophthalmic devices that fall under Class A and Class B
devices that must be registered in CDSCO's new licensing system. This indicates
that manufacturers and importers need to obtain the necessary licenses under
his CDSCO framework to trade such ophthalmic medical devices in the Indian
market. Any person or entity with a manufacturing license issued under the
Pharmaceuticals and Cosmetics Act, of 1940 can apply for registration and
importation of ophthalmic medical devices into India.
Purpose of application:
Any organization wishing to manufacture or import a medical
device on the Central Pharmaceutical Standards Control Organization (CDSCO)
list of notified or unnotified medical devices may do so. The Pharmaceuticals
and Cosmetics Act of 1945 regulates matters relating to the importation,
manufacture, sale, and distribution of medical devices. According to the new
medical regulations of 2017, all medical devices were classified into four
groups based on their ease of use and associated risks:
- Class A (low-risk) devices such as tongue depressors and
thermometers.
- Class B: Low to moderate hazards, including suction
devices, hypodermic needles, etc.
- Class C devices are slightly riskier, such as Lung
ventilators.
- High risk class D techniques such as implanted heart valve
techniques.
Class A&B devices are considered medium risk and low
risk devices that require submission of manufacturing applications to state
regulatory agencies. Class C and D, on the other hand, are considered advanced
and highly dangerous devices and must be applied for at the Central Licensing
Authority of India.
The Drugs &
Cosmetics Act 1940 & Rules 1945 regulates the importation, manufacture,
sale and distribution of medical devices. This means that anyone with a license
to manufacture or wholesale pharmaceuticals issued under the Pharmaceuticals
and Cosmetics Act 1940 and the Regulations 1945 can apply for registration.
Documents required to register ophthalmic medical devices
with CDSCO
To complete his CDSCO registration for ophthalmic medical
devices, the following documents must be included:
- Application.
- Quality certificate
guarantee
- Certificate
according to ISO 13485.
- Plant master report
- Master device
- Design certification from CE
- Marketability
certification by the Global Harmonization Task Force
- International
government certificate or free sale certificate
- A commitment to the
accuracy of the information provided
Who can submit a CDSCO application for registration of
ophthalmic medical devices?- American
manufacturers must complete Form MD-3 and use Form MD-5 to obtain licensees.
Loan license applications and licensees must be submitted on Form MD-4 and Form
MD-6, respectively.
- Applicants must submit Form MD-26 for new medical devices
and Form MD-27 for manufacturing licensees. Applicants must obtain a clinical
license from the manufacturer by submitting a licensee on Form MD-23 and an
application on Form MD-22. New medical device manufacturers must obtain a trial
license by filing Form MD-16 and obtaining a licensee under Form MD-17.
- Foreign manufacturers based in India,
- Subsidiary of this manufacturer
- Authorized distributor of this
manufacturer
- Importers must apply on Form MD-14 and obtain licenses on
Form MD-15 for medical devices already on the market.
Applicants must
submit Form MD-26 Application for the new medical device and Form MD-27 License
for the import license. An application on Form MD-22 and a license on Form
MD-23 must be submitted by the applicant to obtain a clinical import license. A
Form MD-16 application and a Form MD-17 license must be submitted by the
applicant for a new medical device importer trial license.
Conclusion
For free use of ophthalmic medical devices in the Indian
market, the Central Pharmaceutical Standards Control Organization (CDSCO)
established by the Government of India to register under the Medical Devices
Regulations, 2017 and the Drugs and Cosmetics Act, 1940 I am obliged to do so.
These devices are currently on the Notification List regulated by CDSCO. In
order to sell, manufacture, export, import or distribute ophthalmic medical
devices in the Indian market, manufacturers and importers must be informed of the
process, comply with all applicable laws and regulations and comply with state
licensing bodies.
