CDSCO Regulation of Ophthalmic Medical Devices in India

Table of Contents

What is CDSCO?

India ranks as one of the largest producers globally of medical devices and in-vitro diagnostic devices, with millions of such devices manufactured annually. The Central Drugs Standard Control Organisation (CDSCO) is India’s regulatory authority for approving and regulating medical devices. Operating under the Directorate General of Health Services, Ministry of Health and Family Welfare, the CDSCO’s main objective is to safeguard public health. It is responsible for clinical trials, medical investigation, drug and medical devices approval, import licensing, and quality control, among other duties. It is the equivalent of the USA’s FDA.

Role of CDSCO in Ophthalmic Medical Devices Regulation

CDSCO manages the import, manufacture, and sale of drugs and medical devices, including ophthalmic drugs and ophthalmic devices, in India. It oversees the registration process for ophthalmic devices before they are legally marketed in India. Manufacturers and marketers need to secure a CDSCO license to promote their products in India legally. The CDSCO plays a vital role in ensuring that ophthalmic medical device manufacturers and importers comply with the Indian Medical Device Rules (MDR) 2017.

What are Ophthalmic Medical Devices?

To put it simply, Ophthalmic Medical Devices are the devices Eye Doctors, aka Ophthalmologists, use to keep our eyes happy and healthy. Ophthalmic medical devices assist medical practitioners in diagnosing problems and performing delicate surgical procedures when necessary. To simplify the ophthalmic medical device registration process, CDSCO has further classified these devices into risk classes A, B, C, and D. The device and the risk class are detailed below:

Classification of Medical Devices Pertaining to Ophthalmology

S. No.	Device Name	Risk Class

1	Adaptometer	B
2	Amsler grid	A
3	Anomaloscope	A
4	Aqueous/vitreous humour replacement medium kit	D
5	Automated lensmeter (Dioptometer)	A
6	Bagolini lens	A
7	Binocular vision test unit	A
8	Blepharoplasty scissors	A
9	Capsular bag anchor	C
10	Colour discrimination tester	A
11	Colour-discrimination eye chart	A
12	Conjunctival scissors	A
13	Contact Lens (Including Coloured Contact Lens)	B
14	Contact lens agitation cleaning system	B
15	Contact lens disinfecting solution	B
16	Contact lens protein-removal solution	B
17	Contact lens radius gauge	A
18	Contact lens thermal cleaner	B
19	Corneal burr manual instrument	B
20	Corneal burr system	B
21	Corneal burr, abrasion	B
22	Corneal burr, rust ring removal	B
23	Corneal epithelium perforator	B
24	Corneal epithelium trephine	B
25	Corneal inlay, aperture reducing	C
26	Corneal inlay, cornea- reshaping	C
27	Corneal light shield	B
28	Corneal marker	B
29	Corneal resection holder	B
30	Corneal scissors	B
31	Corneal shield	B
32	Corneoscleral punch	B
33	Diagnostic condensing lens	A
34	Donor cornea container	C
35	Eikonometer	A
36	Electronic occlusion spectacles	A
37	Endoscopic-imaging ophthalmic solid-state laser system	C
38	Enucleation scissors	A
39	Epiretinal/inner limiting membrane scraper	B
40	Euthyscope	A
41	Exophthalmometer	A
42	Eye cup	A
43	Eye heat therapy pack	B
44	Eye irrigation shield	A
45	Eye muscle clamp	B
46	Eye muscle sleeve	C
47	Eye pad	A
48	Eye spud	A
49	Eye valve	C
50	Eyelid clamp	A
51	Eyelid weight, external	A
52	Eyelid weight, implantable	C
53	Felt tangent screen	A
54	Femtosecond ophthalmic solid-state laser system	C
55	Fibreoptic general-purpose ophthalmic hook	A
56	Flieringa ophthalmic ring	A
57	Fornixscope	A
58	Fresnel lens	A
59	Fresnel prism	A
60	Fundus-imaging ophthalmic diode laser system	C
61	Fundus-imaging ophthalmic solid-state laser system	C
62	Glaucoma supraciliary implant	C
63	Glaucoma therapy ultrasound system	C
64	Haidinger brush imager	A
65	Hand-held campimeter	A
66	Hand-held telescope	A
67	Hruby fundus lens	A
68	Implantable intraocular pressure monitoring system	C
69	Implantable iris prosthesis	C
70	Indirect binocular ophthalmoscope	A
71	Intracorneal ring	C
72	Intranasal lacrimal neurostimulator	C
73	Intraocular pressure-reducing system	C
74	Keratome	B
75	Lacrimal tube	C
76	Lens spoon	A
77	Maddox trial lens	A
78	Mirror-prism spectacles	A
79	Nystagmus inducing optokinetic drum	A
80	Nystagmus inducing tape	A
81	Ophthalmic calliper	A
82	Ophthalmic clip	C
83	Ophthalmic cryosurgical system	C
84	Ophthalmic distometer	A
85	Ophthalmic dye laser system	C
86	Ophthalmic excimer laser system	C
87	Ophthalmic head reflector	A
88	Ophthalmic Irrigation Solution (Balanced Salt Solution)	B
89	Ophthalmic noble gas laser system	C
90	Ophthalmic operating table top	A
91	Ophthalmic soft-tissue surgical forceps	B
92	Ophthalmic surgical device handling forceps	A
93	Ophthalmic suture scissors	A
94	Ophthalmic tonometer	B
95	Ophthalmic ultrasound imaging system	B
96	Ophthalmodiastimeter	A
97	Ophthalmoleukoscope	A
98	Ophthalmoscope	B
99	Optical pachymeter	A
100	Orbital depressor	A
101	Orbital rim prosthesis	C
102	Perimeter	A
103	Periocular/lacrimal retractor	A
104	Phacoemulsification system	C
105	Phorometer	A
106	Phoropter	A
107	Pleoptophor	A
108	Polatest	A
109	Ptosis sling	C
110	Pupillograph	A
111	Pupillometer	A
112	Retinal tack	C
113	Scleral buckling device	C
114	Scleral expansion implant	C
115	Scleral marker	B
116	Sclerotome	A
117	Scotometer	A
118	Surgical binoculars	A
119	Symblepharon ring	C
120	Synoptophor	A
121	Tachistoscope	A
122	Ultrasound pachymeter	B
123	Visual chart	A
124	Visual light box	A
125	Visual projector	A
126	Visual evoked-potential electrode	A
127	Vitrectomy system	C
128	Vitreous body prosthesis	C
129	Intraocular fluid	C
130	Intraocular gas	C
131	Intraocular lens guide	B
132	Ophthalmic refractometer	B
133	Keratoscope	B
134	Contact Lens Inserter/Remover	A
135	Ophthalmic working-channel cannula	B

CDSCO’s Regulatory Framework for Medical Devices

Regulatory Authority and Legal Framework

CDSCO is the primary regulatory body for medical devices in India. The Drugs Controller General of India (DCGI) is the top regulatory authority, and the DCGI supervises CDSCO’s operations. There are two licensing authorities in India that provide licenses for medical devices.

CLA (Central Licensing Authority): They provide the manufacturing license for Class C (moderate to high risk) and Class D (high risk) medical devices along with Import Licenses for all Classes of Medical Devices.

SLA (State Licensing Authority): They provide the manufacturing license for Class A (low risk) and Class B (low to moderate) medical devices.

Classification of Medical Devices in India

India prioritizes safety and adheres to a risk-based classification system for medical devices, akin to international standards.

Class	Risk Level	Example
A	Low	Eye Pad
B	Low to moderate	Contact Lens
C	Moderate to high	Intraocular lens
D	High	Aqueous/vitreous humour replacement medium kit

CDSCO Approval Process for Ophthalmic Medical Devices

The CDSCO Ophthalmic Medical Devices approval process prioritizes public health. All ophthalmic devices, regardless of their risk category, must receive CDSCO approval prior to marketing.

Step-by-Step process of device approval

Classification: Select the risk class of your ophthalmic medical device on the basis of CDSCO’s guidelines.

Documentation: Collect all necessary documents, including the clinical trial report, ISO 13485 certificate, product specifications, and performance report.

Enrollment on SUGAM Medical Devices Portal: Enroll your organization on CDSCO’s official portal, SUGAM. Submit all necessary details of devices and their corresponding documents.

Review/Inspection: CDSCO will thoroughly review the submitted documents and, with a team, thoroughly audit and inspect the manufacturing site.

Certification: Upon fulfilment of all requirements, CDSCO issues the certificate of approval.

What if an ophthalmic device lacks a predicate?

For devices lacking a predicate, emphasis must be placed on clinical investigation data, safety, performance, and efficiency. Clinical investigation data is crucial in these cases. The applicant must provide the application with a detailed report of clinical investigation, scientific literature to support their claims, and a comprehensive report of the risk-benefit analysis. Such devices may undergo thorough scrutiny by the CDSCO.

Challenges Faced by Manufacturers and Importers

Registering ophthalmic medical devices can present challenges and complexities. These obstacles can affect market entry, lack of access to critical medical devices and operational challenges.

CDSCO requires several documents, including the Device Master File, Plant Master File, ISO certificates, etc. Preparing these documents can be time-consuming and technically demanding, especially for novel devices or those lacking a predicate.

Regulatory Hurdles in the Indian Market

The Indian market for ophthalmic medical devices is continuously evolving, adding more complexity to the registration process. Misclassification, inspection delays, or prolonged CDSCO licensing process for ophthalmic medical devices will result in extended timelines in accessing the Indian market.

Navigating Bureaucratic Processes

Delays in application processing are frequent in India’s medical devices industry. Approval can take several months to years, impacting manufacturer’s and Importer’s launch timelines and business planning.

New online systems have been introduced for market standing and non-conviction applications to simplify the process of obtaining certificates. As a result, companies will need to adapt to these new methods and may have to redo applications whenever rules change.

Ensuring Device Quality and Safety

The regulatory bodies expect manufacturers and importers to maintain robust Quality Management Systems (QMS) in compliance to Medical Devices Rules 2017. However, this is a time-consuming and resource-intensive task, especially for smaller and medium-sized businesses.

The CDSCO regularly conducts audits and inspections of medical device manufacturing units to ensure ongoing compliance. This requires manufacturers to maintain high standards and promptly address any irregularities.

Conclusion

CDSCO has established a framework for licensing and registration of ophthalmic medical devices. By adhering to the framework, process, and guidelines, ophthalmic device manufacturers & importers safeguard patients and protect their own market image. Non-compliance may result in fines and potential shutdown.

CDSCO is adopting stricter rules and regulations regarding these devices. Being informed is vital for the success of manufacturers and importers of these devices.

Frequently Ask Questions (FAQs)

1. Is CDSCO registration necessary for all ophthalmic devices?

Yes! Every ophthalmic medical device must be registered with the CDSCO

2. What are the consequences of failing to register my ophthalmic device with CDSCO?

You cannot sell unregistered ophthalmic devices in India, and you can also be penalized.

3. Am I eligible to apply for CDSCO registration?

Any manufacturer, importer, or distributor can apply for CDSCO registration of ophthalmic medical devices.

CDSCO Ophthalmic Medical Devices License- All You Need to Know