CDSCO Classification of Medical Devices 2026: An Overview

CDCSO manages the classification of medical devices. The authority operates under the purview of the Drug Controller General of India. The CDSCO classification of medical devices is useful for manufacturers, importers, and health staff.

The Drugs and Cosmetics Act, 1940, provides the regulatory structure for all medical devices in India. The Medical Device Rules, 2017, fulfil safety, quality, and performance standards for medical devices before entering the Indian market. CDSCO registration seekers must know this.

The Health Ministry of India introduced new medical devices and IVD regulations. It will enhance the effectiveness of the Drugs and Cosmetics Act 1940. The said regulations came into effect on Jan 1, 2018. Read the blog to know more about the CDSCO Classification of Medical Devices, along with their categories, regulatory framework, effects, key challenges, penalties, and costs.

New Medical Devices Rules India, 2017

The New Medical Devices Rules, India, 2017, reduce the frequency of periodic renewal of licenses. Accordingly, the production and import licenses shall continue to stay valid until it is revoked, suspended, or surrendered.

The entire licensing process is completed online via a dedicated online portal known as SUGUM. The said portal shall ensure seamless submission, tracking, and review of the registration documents.

Regulators have already been briefed on the timeline of all the activities concerned. The said regulations fulfil international regulations.

The SUGUM Portal shall also provide the facility for a change in registration. The applicant can access this facility via “Post Approval Change.”

India’s Medical Device Market in 2026: Why CDSCO Classification is needed?

India is the fourth-largest medical device market in Asia after Japan, China, and South Korea. It accounts for roughly 1.6% of global medical technology. The medical device market grew from $20.98 Billion in 2026. It is projected to reach $38.08 Billion by 2030. The market share of imports (62%) is higher than the domestic production (38%) for the Indian medical device industry in FY2025-26.

Despite a strong domestic production in syringes, consumables, and simple disposables, India remains import-dependent for cardiology, oncology, and high-end imaging.  It is the biggest reason why import license (MD-15) volumes consistently outstrip manufacturing license (MD-5/MD-9) volumes at CDSCO each fiscal year.

Indian Medical Device Market Share FY2025-26

Here is a quick list for the product categories under the Indian medical device market, FY2025-26:

• Diagnostic Imaging: 22% market share
• Consumables and Disposables: 19% market share
• Patient Aids: 14% market share
• IVD/Reagents: 14% market share
• Orthopaedic and Prosthetic: 12% market share
• Cardiology: 10% market share
• Others: 5% market share

Top Source Countries for Medical Device Imports into India (FY2025-26)

Find the list of the top countries importing medical devices in India for FY2025-26:

• USA
• Germany
• China
• Singapore
• Japan
• Netherlands
• Others

Legal and Regulatory Framework for the CDSCO Classification of Medical Devices

Here is a list of the regulations in the CDSCO Classification of Medical Devices, given as follows:

• Drugs and Cosmetics Act, 1940
• Drugs and Cosmetics Rules, 1945
• Medical Device Rules, 2017
• MDR Amendment, 2020
• MDR (Amendment) Rules, 2022
• National Medical Device Policy, 2023
• MvPI Operational Guidelines, 2024-25
• NDCT Rules/ IND Device Pathway, Updated 2025

Regulatory Approvals for CDSCO Classification of Medical Devices

The new regulations ensure the proper CDSCO classification of medical devices in line with international standards and remove the prevailing gaps.

The National Medical Device Authority shall hold the authority to advocate for the domestic medical device market, which includes specific price limits, safety standards, and price control policy for related surgical devices.

Presently, 22 notified medical devices listed under the Drug and Cosmetic Act, 1940, are required to secure the medical device registration from the CDCSO. See the list of the New Medical Devices given below:

• Disposing of Hypodermic Syringes
• Disposing of Hypodermic Needles
• Disposing of Perfusion Sets
• In Vitro Diagnostic devices for AIDS, HBsAG, and HCV
• Cardiac Stents
• Drug-Eluting Stents
• Catheters
• Intraocular Lenses
• I.V. Cannula
• Bone Cements
• Heart Valves
• Scalp Vein Set
• Orthopedic implant
• Internal Prosthetic Replacement
• Ablation Device

CDSCO Classification of Medical Devices under the New Rules

The medical devices listed under the new Rules “Medical Devices Rules, 2017”, are categorized as per the Global Harmonization Task Force, depending on associated risks. See below with their distribution:

• Class A (Low Risk): 42%  
• Class B (Low-Moderate Risk): 34%
• Class C (Moderate High Risk): 17%
• Class D (High Risk): 7%

Class A and B: The State Licensing authority shall deal with the licensing of these classes. Entities willing to deal with these entire classes can send the application to the State authority in the prescribed manner.

Class C and D: The Central licensing grants regulatory consent for the registration of medical devices.

The producers of medical devices shall be required to comply with risk-proportionate regulatory norms cited under the Rules.

CDSCO Classification of Medical Devices: List of New Medical Devices & their Class

The medical devices classification covers a wide array of devices in the grouping form, such as stents and cannulas, into more specific sub-groups, such as coronary stents and ureteral stents. CDCSO has underpinned the classification of new sub-groups with risk analysis methods, which are vital under the Medical Devices Rules, 2017.

CATEGORY A – LOW RISK

SPECIALTY	DEVICES COVERED	PURPOSE
Surgical Aids	Kidney tray, cotton swabs, surgical retractors, sterile drapes.	Operation Theatre (OT)
General Care	Tongue, Depressors, oxygen masks (non-active), examination lights	Routine examination and oxygen delivery
Mobility	Crutches, wheelchair, walking stick	Patients without activeness to move
Wound Care	Adhesive bandage, plasters, sterile dressings, gauze	Short-term wound coverage

CATEGORY B – LOW-TO-MODERATE RISK

SPECIALTY	DEVICES COVERED	PURPOSE
Anaesthesia	Tracheal tubes, laryngoscopes (non-active), face masks	Airway Management
Cardiology (Diag.)	Single-use ESG electrode, digital BP monitors, and pulse oximeters	Cardiac monitoring
Surgery	Hypodermic syringe, blood collection lancets sutures (non-absorbable, short-term)	Routine surgical and phlebotomy use.
Hearing & Vision	Hearing aids, magnifying spectacles, and daily-wear contact lenses	Sensory correction
Imaging Accessories	Ultrasound transducer covers, MRI cushions	Accessory consumables for imaging.

CATEGORY C – MODERATE-TO-HIGH RISK

SPECIALTY	DEVICES COVERED	PURPOSE
Cardiology	Coronary catheter guidewires, ballon angioplasty catheters, cardiac monitors (active)	Diagnostic and interventional cardiology
Anaesthesia/ ICU	Ventilators (invasive), infusion pumps, and anaesthesia workstations	Active Life Support
Orthopedics	Dental implants, Bone fixation plates and screws, intramedullary nails	Surgically invasive long-term implants
Imaging	Ultrasound scanners, mammography units, X-ray fluoroscopy systems, mobile C-arms	Active diagnostic imaging
Surgery	Surgical lasers, robotic surgical systems (assistive)	Active therapeutic energy delivery
Software	Diagnostic AI Software for radiology triage (non-life threatening)	Software as a Medical device, IMDRF Cat 3.

CATEGORY D – HIGH RISK

SPECIALTY	DEVICES COVERED	PURPOSE
Cardiology	Implantable pacemakers, ICD/CRT-D devices, prosthetic heart values, drug-eluting stents	Active long-term implantable; central circulatory system
Neurology	Cochlear implants, deep brain stimulators, neurovascular embolization coils	CNS contact, life supporting
Ophthalmology	Intraocular lenses (anterior + posterior), retinal prostheses	Long-term implantable in a vital optical pathway.
Reproductive Health	Intra-uterine devices (hormone-releasing), hysteroscopic implants	Long-term implantable, hormonal combination
IVD Class D	HBV, HIV, HCV NAT assays for blood-bank screening	Detect transmissible agents in blood/tissue donations.
Combination	Drug-coated ballons, bioabsorbable scaffolds with active pharmaceutical ingredient	Device-drug combination products.

CDSCO Registration and Approval Pathways: MD-5, MD-9, & MD-15 Clarified

Once the CDSCO classification of medical devices is determined, the next step is licensing. The CDSCO approval depends on the manufacturing and importing of medical devices and the risk class. Look at the given table to know the output form, issuing authority, application, and activity as per the risk class.

RISK CLASS	ACTIVITY	APPLICATION FORM	ISSUING AUTHORITY	OUTPUT FORM
A/B	Manufacture	MD-3 (loan)/MD-5 (own)	State Licensing Authority	MD-5
C/D	Manufacture	MD-7 (loan)/MD-9 (own)	Central Licensing Authority (CDSCO)	MD-9
A, B, C, or D	Import	MD-14 with MD-15 application	Central Licensing Authority (CDSCO)	MD-15
All	Wholesale Sale	MD-41 (general/restricted)	State Licensing Authority	MD-42
All	Retail Sale	MD-41	State Licensing Authority	MD-42
C/D (New Device)	Clinical Investigation	MD-22	CDSCO+ Ethics Committee	MD-23 (Permission)
C/D	Performance Evaluation (IVD)	MD-24	CDSCO+ Ethics Committee	MD-25
All	Test License	MD-12	Central/State LA per class	MD-13

SPECIAL PATHWAYS

Predicate-Equivalence Pathway covers class C and D medical devices that are US FDA, EU under MDR/IVDR, Australia, Japan, Canada, or the UK MHRA approved. It provides leverage for foreign approvals to bypass mandatory in-country clinical investigation, provided a justification of equivalence is filed with safety data.

India has brought a quick approval route for innovative medical devices under the New Drugs and Clinical Trials (Amendment) Rules, 2025, managed by CDSCO, as it reviews and provides feedback within 30 working days at each step.

Regulatory Authority for CDSCO Classification of Medical Devices

The CDSCO body has the power/authority to:

• License approval for manufacturing and importing.
• On-site inspection in the manufacturing plant.
• Strictly check if a device is unsafe.
• Monitor the post-market surveillance for adverse impacts.

Documents Required in CDSCO by Risk Class

Find the structured table below mapped as per A, B, C, and D class of the CDSCO classification of Medical Devices:

DOCUMENT	CLASS A	CLASS B	CLASS C	CLASS D
Cover letter & Form MD-3/7/14	Yes	Yes	Yes	Yes
Plant Master File (PMF)	Yes (Basic)	Yes	Yes (detailed	Yes (detailed
Device Master File (DMF/CSDT)	Summary	Yes	Detailed	detailed + risk file
ISO 13485:2016 Certificate (or BIS IS 13485)	Recommended	Mandatory	Mandatory	Mandatory
Risk Management File (ISO 14971)	Optional	Recommended	Mandatory	Mandatory
Biocompatibility (ISO 10993 series)	If applicable	If applicable	Mandatory if patient-contacting	Mandatory
Sterility/Validation Reports	If applicable	If applicable	Mandatory if sterile	Mandatory if sterile
Electrical/EMC Reports (IEC 60601)	–	If active	Mandatory if active	Mandatory if active
Clinical Evaluation Report (CER)	–	Light	Detailed	Detailed+ India trial unless predicate
Predicate/Free sale certificate	–	Recommended	Mandatory	Mandatory
Labels, IFU and Pack-Insert (English + Hindi where applicable)	Yes	Yes	Yes	Yes
Authorized Indian Agent appointment (imports)	Yes	Yes	Yes	Yes
Power of attorney notarized + apostilled)	Yes	Yes	Yes	Yes
Government Fee Proof (TR-6 challan)	Yes	Yes	Ye	Yes

Best Ways for CDSCO Registration in India

Know the best ways of CDSCO registration for class A, B, C, D medical devices:

Class A and B:

CDSCO registration of Class A and B requires self-certification for Indian manufacturers or an Import license for foreign manufacturers.

Class C and D

CDSCO registration of Class C and D requires mandatory approval by clinical trial or performance assessment.

CDSCO Registration Fees 2026 As Per Government Structure

CDSCO registration fees are generated directly from the CDSCO classification of medical devices. The fee schedule is laid down in Schedules I and II of MDR 2017, revised in 2024. The fee is payable through a Challan in favor of the Pay & Accounts Officer, Department of Health and Family Welfare.

The given table below is revised as of April 2026 for the CDSCO registration fees for A, B, C, and D class based on an activity or form.

ACTIVITY/FORM	CLASS A	CLASS B	CLASS C	CLASS D
Manufacturing: Site Fee (MD-5 / MD-9)	Rs.5,000	Rs.5,000	Rs.50,000	Rs.50,000
Manufacturing:Per Device Fee	Rs.500	Rs.500	Rs.1,000	Rs.1,000
Loan license (MD-3 / MD-7)	Rs.5000	Rs.5000	Rs.50,000	Rs.50,000
Import License: Site Fee (MD-15)	US$1,000	US$2,000	US$3,000	US$3,000
Import License: Per Device Fee	US$50	US$1,000	US$1,500	US$1,500
Test License (MD-12 / MD-13)	Rs.500	Rs.500	Rs.500	Rs.500
Clinical Investigation Permission	–	–	Rs.1,00,000	Rs.1,00,00
Sale License (MD-41/MD-42)	Rs.3,000	Rs.3,000	Rs.3,000	Rs.3,000

The fee structure of Class D is higher in comparison to Class A, which is less costly and affordable, too.

CDSCO Approval Timeline 2026: How Long Does CDSCO Registration Take?

The statutory timeline under the MDR 2017 varies by CDSCO classification of medical devices. Here is the average CDSCO License approval timelines by Risk Class (2026):

• Class A takes maximum 60 days and a minimum of 30 days
• Class B takes maximum 120 days and a minimum of 60 days
• Class C takes maximum 240 days and a minimum of 120 days
• Class D takes maximum 365 days and a minimum of 180 days

Below is a structured table for risk class based on stages:

STAGE	CLASS A & B	CLASS C & D
Pre-submission readiness review (in-house)	2 to 3 weeks	4 to 8 weeks
SUGAM/NSWS submission acknowledgement	1 to 3 days	1 to 3 days
Document scrutiny (deficiency letter, if any)	30 to 45 days	60 to 90 days
Manufacturing location/desktop audit	30 days	60 days
Final order issuance	60 days from clean file	90 days from clean file
End-to-end realistic timeline	3 to 4 months	6 to 12 months

Primary Purposes of Obtaining the CDSCO Certification in India

Find the list for a wide range of purposes of securing the CDSCO certification in India, given below:

• Export NOC (Zone)
• Cosmetic Registration
• CDSCO Test License
• Dual Use NOC (Trader)
• Formulation R&D Organization
• Blood Product Registration
• Sponsors (BA/BE and CT)
• Ethics Committee
• Blood Bank Registration

CDSCO’s Effects on the Healthcare System & Patients

Here are a few highlights of CDSCOs’ effects on the healthcare system and patients, given as follows:

• Legally approved devices: Every medical device must be legally approved to fulfil safety, quality, and performance standards. It lowers the risk of healthcare systems.
• Safety of the Patient: Install legally approved instruments under the CDSCO classification of medical devices. They must be tested and evaluated to ensure patient safety during diagnosis, treatment, and medical procedures.
• Contribute to Next-Gen Technology: Implement the use of advanced medical technology, ensuring regulatory compliance and using customers’ feedback, too. It leads to safer, smarter, and more effective healthcare technologies in the future.
• Post-Surveillance Monitoring: The medical devices are under post-surveillance monitoring after approval to track performance.

Major Challenges in the CDSCO Registration Process

Applicants face serious challenges during the CDSCO registration process. From wrong CDSCO classification of medical devices, minor errors, and missing files, there are more challenges. So, if you’re going through something similar, look for the key challenges during the CDSCO registration process, given as follows:

• Risk-prone instruments under CDSCO classification face delayed approvals due to strict norms.
• Less knowledge of the CDSCO regulatory framework and norms causes delays, errors, and compliance issues in the CDSCO registration procedure.
• Fake, low-quality, or unapproved instruments may harm patients.
• The CDSCO registration process requires excessive technical data, documents, and reports. Even a small error or a missing credential may lead to rejection.
• The wrong CDSCO classification of medical devices results in delays and legal issues associated with it.

Major Reasons for CDSCO Application Rejections

Find the top reasons for CDSCO applications queries or rejections:

• Inadequate QMS / ISO 13485 doc: 28%
• Incomplete device master file: 22%
• Labelling non-compliance: 17%
• Clinical evidence gaps: 14%
• Plant master file issues: 11%
• Other (fees, signatures): 8%

CDSCO vs US FDA vs EU MDR: How the CDSCO Classifications of Medical Devices Compare Globally?

The comparison of CDSCO classification with US FDA vs EU MDR is based on several dimensions provided in the table below:

DIMENSIONS	CDSCO (INDIA)	US FDA	EU MDR/IVDR
Classification Taxonomy	Class A/B/C/D	Class I/II/III	Class I/IIa/IIb/III+ IVDR Class A – D
Pre-market pathway	MD-9/MD-15 with DMF + clinical investigation	PMA: Pre-market approval	CE Marking via notified body, Annex VII conformity
Statutory approval timeline	270 days (MDR Rule 32: C/D)	180 days FDA review goal	Variable, typically 12 to 18 months
Government Fee bracket	US$3,000 to US$5,000	US$38,000+ (PMA fee FY26)	Notified body fees: EUR 25,000 to EUR 80,000
Clinical investigation requirement	It is mandatory unless predicate from listed jurisdictions	Almost always mandatory	Almost always mandatory; PMCF mandatory
Post-market compliance	MvPI + PSUR by class	MDR+MAUDE database	PSUR+EUDAMED+ Periodic safety reports
UDI	CUDID, mandatory for C/D from Oct-25	GUDID, mandatory by class	EUDAMED, mandatory by class
Reliance /Convergence	Reliance on listed regulators (US, EU, JP, AU, CA, UK) for predicate	Limited reliance	Limited; CE accepted by some non-EU markets.

Future Outlook: CDSCO Classification of Medical Devices 2026-2030

The three driving factors for growing prospects of CDSCO classification of medical devices 2026-2030 are:

• National Medical Devices 2023 targets 10x domestic manufacturing of US$50 billion by 2030.
• India aligning with international systems, and submissions are likely to be in a standardized digital format, like eCTD by 2027.
• India is updating its rules to handle modern technologies like Software-as-a-Medical Device (SaMD) and AI/ML. New guidelines for telemedicine and remote monitoring were introduced in February 2026.

Manufacturers staying ahead by digitizing documentation, building UDI into the products, aligning clinical data for India/US/EU, and adding strong cybersecurity get quicker and easier approvals from the Central Drugs Standard Control Organization.

Conclusion

The policy for the CDSCO classification of medical devices seeks to strengthen the Drug and Cosmetic Act by encompassing the above products. Continuing research for better treatment has flooded the healthcare sector with new medical devices that are being used without any regulation. The new medical device policy seeks to address this gap by covering comprehensive legal regulations to protect the public interest.

To get expert-led support in CDSCO registration, talk to our experts at Corpbiz.

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