A CDSCO rehabilitation medical device license is mandatory under India's Medical Devices Rules, 2017 for any manufacturer or importer of notified rehabilitation devices. CDSCO notified 60 rehabilitation medical devices on 13 September 2021, classified across Class A, B, and C only — there is no Class D device in this category. Manufacturing Class A and B devices (such as exothermic heat therapy packs, bicycle ergometers, and cold-air therapy units) requires a Form MD5 license from the State Licensing Authority (fee: Rs. 5,000 plus Rs. 500 per device). Manufacturing Class C devices — the highest risk tier notified in this category, including pulsed signal therapy systems, foot sensorimotor therapy mechanical neurostimulators, and interferential electrical stimulation systems — requires a Form MD9 license from CDSCO Central (fee: Rs. 50,000 plus Rs. 1,000 per device). Importing any class requires a Form MD15 import license from CDSCO. All license types are valid indefinitely, subject to a retention fee paid every 5 years — non-payment results in automatic cancellation. Applications are submitted through the CDSCO SUGAM portal (cdscoonline.gov.in). ISO 13485 certification and a comprehensive Device Master File are mandatory for all manufacturing license applications.
Rehabilitation medicine is the clinical discipline concerned with restoring function, mobility, and independence to patients recovering from injury, surgery, stroke, amputation, and chronic musculoskeletal or neurological conditions. The medical devices that support this discipline range from straightforward thermal therapy packs and mobility aids to sophisticated electrical stimulation systems, biofeedback platforms, and powered rehabilitation robotics that actively drive neuromuscular re-education. Across this spectrum, rehabilitation medical devices play a defining role in patient recovery outcomes — determining how completely and how quickly a patient regains function after a debilitating medical event.
India's rehabilitation healthcare landscape is expanding rapidly, shaped by an ageing population, rising stroke incidence, growing road traffic injury caseloads, and a maturing physiotherapy and sports medicine sector reaching deeper into tier-2 and tier-3 cities. For manufacturers and importers entering this space, a distinctive feature of CDSCO's regulatory framework sets rehabilitation apart from most other medical device categories: it is one of the few categories with no Class D device at all. Understanding this classification structure — along with the applicable license types, documents, and application process — is the essential foundation for compliant, efficient market entry.
📑 Quick Navigation
- Demand for Rehabilitation Medical Devices in India
- CDSCO Regulations: Why Mandatory Compliance Matters
- CDSCO Classification: Rehabilitation Devices by Class
- Mandatory Documents for CDSCO Rehabilitation Device License
- CDSCO License Types: MD5, MD9, MD15
- 5-Step Application Process Through CDSCO SUGAM
- License Validity and Retention Fee Requirements
- 5 Benefits of CDSCO Licensing for Rehabilitation Device Manufacturers
- How Rego Services Supports Your CDSCO Application
- Frequently Asked Questions
Demand for Rehabilitation Medical Devices in India
India's rehabilitation medical device market is being shaped by a powerful combination of demographic and epidemiological trends. The country's ageing population, rising incidence of stroke and degenerative musculoskeletal disease, and a persistently high burden of road traffic injuries are together generating sustained, structural demand for rehabilitation devices at every tier of the healthcare system — from district hospital physiotherapy units to specialised neuro-rehabilitation and sports medicine centres in metropolitan hospitals.
The expansion of physiotherapy, occupational therapy, and sports medicine infrastructure into tier-2 and tier-3 cities is driving procurement of a wider range of rehabilitation devices — from basic thermal and electrotherapy equipment to interferential electrical stimulation systems and powered rehabilitation robotics — by private clinics and hospitals competing on the quality of recovery outcomes they can offer. At the same time, growing clinical and patient awareness that structured rehabilitation materially improves recovery after surgery, stroke, and orthopaedic injury is increasing both public and private investment in rehabilitation departments and equipment.
Growing clinical adoption of electrical stimulation and neuromuscular re-education technologies — including functional electrical stimulation for gait correction and interferential current therapy for pain and muscle re-education — is increasing demand for the Class C devices that sit at the technically demanding end of this category. For device companies entering this segment with a valid CDSCO license, the addressable market spans government rehabilitation programmes, private hospital physiotherapy department procurement, and the growing standalone physiotherapy and sports medicine clinic sector across India's expanding urban centres.
CDSCO Regulations: Why Mandatory Compliance Matters
The clinical environment in which rehabilitation medical devices are used — recovery from stroke, post-surgical mobility restoration, and neuromuscular re-education following nerve or spinal injury — places these devices in a category where inconsistent performance or inadequate safety controls can directly compromise patient recovery outcomes. The consequences of an interferential electrical stimulation system that delivers inconsistent current output, or a powered rehabilitation robotic device with inadequate safety interlocks during gait training, extend directly into a patient's functional recovery trajectory at a clinically vulnerable stage of their care.
CDSCO's regulatory framework for rehabilitation medical devices under the Medical Devices Rules, 2017 is built on this recognition. By requiring manufacturers and importers to obtain a CDSCO license, demonstrate ISO 13485-certified quality management systems, and submit comprehensive Device Master Files with performance and safety data, CDSCO ensures that every notified rehabilitation device entering the Indian market has been assessed against a defined quality and safety standard. For manufacturers and importers, this means a valid CDSCO license is not a discretionary compliance step — it is a mandatory legal prerequisite for placing rehabilitation devices on the Indian market.
CDSCO Classification: Rehabilitation Devices by Class
The Medical Devices Rules, 2017 classify all notified medical devices into risk-based classes — A (lowest risk) through D (highest risk). For rehabilitation devices specifically, CDSCO's notified list spans only Class A through Class C; this category contains no Class D device. Understanding the class of your specific device is the mandatory first step that determines which license form to use, which authority issues the license, and the fee structure that applies.
- Exothermic heat therapy pack
- Acupressure calf band
- Cervical pillow / lumbar support cushion
- Walking stick / single-point cane
- Non-powered crutch
- Anatomical positioning wedge
- Hand grip strengthening exerciser
- Bed / chair electric massager
- Bicycle ergometer (rehabilitation)
- Cold-air therapy unit
- Heat therapy gel pack (powered)
- Foot bath / hydrotherapy unit
- Powered wheelchair (Class A/B by configuration)
- Continuous passive motion (CPM) device
- Standing frame (powered or manual)
- Pulsed signal therapy system
- Foot sensorimotor therapy mechanical neurostimulator
- Interferential electrical stimulation system
- Functional electrical stimulation (FES) system for gait correction
- Powered rehabilitation robotics (gait / limb training)
- Neuromuscular biofeedback stimulation system
Mandatory Documents for CDSCO Rehabilitation Device License Application
To apply for a CDSCO rehabilitation medical device license, applicants must compile a defined set of supporting documents. The quality, completeness, and internal consistency of this document set is the primary factor that determines how efficiently the application progresses through CDSCO review — and, for Class C devices, through facility inspection and technical scrutiny by the Central Licensing Authority.
- Organisation identity proof — Certificate of Incorporation, Memorandum and Articles of Association, GST registration certificate, and other applicable documents establishing the legal identity and standing of the applicant company. All documents must consistently reflect the same registered entity name and address.
- Sale Deed or Rent Deed of the premises — Valid documentary evidence confirming the applicant's legal right to occupy the declared manufacturing premises. The address on this document must match precisely the facility address declared in the Plant Master File and on the SUGAM application form.
- Building layout with dimensions — An accurate, dimensioned floor plan of the manufacturing facility showing all production areas, quality control laboratory, raw material and finished-goods storage zones, personnel areas, and product flow routes — prepared in accordance with CDSCO requirements. For Class C devices involving electronic assembly, the layout must clearly indicate ESD-controlled workstations and testing areas.
- Plant Master File (PMF) — A comprehensive document describing the manufacturing facility: location, layout, equipment list and calibration records, manufacturing process flows, quality control procedures, personnel structure, GMP compliance infrastructure, and storage conditions. For Class C rehabilitation devices such as interferential electrical stimulation systems and powered rehabilitation robotics, the PMF must demonstrate rigorous electronics assembly quality control and appropriate test and calibration equipment for the device category.
- Device Master File (DMF) — The comprehensive technical dossier for the rehabilitation device: device description and intended use, design documentation, materials specification and biocompatibility assessment where the device has skin contact, manufacturing process description, risk management file under ISO 14971, performance and safety testing data against applicable standards (IEC 60601-1, IEC 60601-2-10 for nerve and muscle stimulators), software validation records where the device incorporates programmable stimulation parameters, labelling and Instructions for Use, and post-market surveillance plan. For Class C electrical stimulation devices, the DMF must address output current accuracy, electrode safety, and programmable parameter validation with supporting test data.
- Documents for the team of qualified and experienced staff — Curriculum vitae, educational qualifications, appointment letters, and training records for personnel responsible for manufacturing and testing the rehabilitation devices, demonstrating CDSCO's minimum qualification requirements are met for technical and quality roles.
- Environmental regulation compliance documents — Applicable Pollution Control Board No-Objection Certificate and waste disposal documentation, particularly relevant where manufacturing processes involve electronics assembly with regulated waste streams such as solder and component waste.
- ISO 13485 Certificate — A current, valid certificate from an IAF-accredited certification body, with scope explicitly covering the manufacturing activities relevant to the rehabilitation device being licensed, such as electrical stimulation systems or powered therapeutic equipment.
- Certificate of Analysis for 3 consecutive production batches — Laboratory analysis and performance test results demonstrating that three sequential production batches consistently meet all declared specifications. For first-time manufacturers, these batches must be produced under a valid CDSCO MD13 test license before the MD5 or MD9 application can proceed.
- Test License (if required) — Where initial production batches were manufactured under an MD13 test license prior to the permanent license application, a copy of that license must be included as a supporting document contextualising the submitted batch data.
For Class C rehabilitation devices — pulsed signal therapy systems, foot sensorimotor therapy mechanical neurostimulators, and interferential electrical stimulation systems — the Device Master File receives the most intensive CDSCO scrutiny within the rehabilitation category. Output current and waveform accuracy testing, electrode-tissue interface safety data, and programmable parameter validation are the technical areas most commonly queried by CDSCO reviewers. Manufacturers should ensure these sections of the DMF are prepared with specialist input and are fully supported by testing data from accredited laboratories.
CDSCO Medical Device Test License (MD13 / MD17) India 2026 — Complete Guide
If you are a first-time manufacturer of rehabilitation medical devices, you will need to produce a Certificate of Analysis for three consecutive production batches before applying for the MD5 or MD9 permanent manufacturing license. An MD13 test license is the legally required prerequisite for manufacturing these batches. This guide covers the complete test license process — mandatory documents, the SUGAM application, and validity rules.
CDSCO License Types for Rehabilitation Medical Devices: MD5, MD9, MD15
Because rehabilitation devices are classified only across Class A, B, and C, two manufacturing license pathways apply — determined by the risk class of the specific device — alongside a single import license pathway covering all classes.
Manufacturing Class A and B rehabilitation devices — such as exothermic heat therapy packs, bicycle ergometers, cold-air therapy units, and continuous passive motion devices — requires an MD5 license from the State Licensing Authority of the state in which the facility is located, with a base fee of Rs. 5,000 plus Rs. 500 per distinct device. Manufacturing Class C rehabilitation devices — pulsed signal therapy systems, foot sensorimotor therapy mechanical neurostimulators, interferential electrical stimulation systems, and powered rehabilitation robotics — requires an MD9 license from CDSCO's Central Licensing Authority, with a base fee of Rs. 50,000 plus Rs. 1,000 per distinct device. Since rehabilitation has no Class D device, the MD9 pathway represents the highest level of regulatory scrutiny applicable anywhere in this category. Importing rehabilitation devices of any notified class into India requires an MD15 import license from CDSCO regardless of the device's risk class.
5-Step Application Process Through CDSCO SUGAM
The CDSCO rehabilitation medical device license application follows a defined five-step process, filed entirely through the CDSCO SUGAM online portal at cdscoonline.gov.in. Selecting the correct form — MD5, MD9, or MD15 — based on the confirmed device classification is a prerequisite to beginning the application.
Compile all mandatory supporting documents: organisation identity proof, Sale Deed or Rent Deed of the premises, dimensioned building layout, Plant Master File, Device Master File, qualified personnel documentation, environmental compliance certificates, Certificate of Analysis for three consecutive batches, ISO 13485 certificate, and MD13 test license where applicable. Every document must be internally consistent — the intended use in the DMF must match Form MD5/MD9/MD15 exactly, the facility layout must match the PMF, and personnel records must align with the qualifications declared in the application. Inconsistencies between documents are the most common source of CDSCO reviewer queries for rehabilitation device applications.
File the application online at cdscoonline.gov.in, selecting the applicable license form — MD5 (Class A/B manufacture), MD9 (Class C manufacture), or MD15 (import all classes). Complete all fields accurately, attach all supporting documents in the specified file formats and within the portal's size limits, and pay the applicable government fee. Fee payment formally submits the application — prior to payment, it remains in draft status and has not been received by the licensing authority for review. Retain the application reference number generated on submission for all subsequent correspondence.
CDSCO may raise written queries on the submitted application and documents through the SUGAM portal — typically relating to the Device Master File's technical content, the ISO 13485 certificate's scope coverage, or the completeness of batch Certificate of Analysis data. For Class C devices such as interferential electrical stimulation systems and pulsed signal therapy systems, queries relating to output current accuracy and electrode safety testing data are common. All queries must be addressed promptly, accurately, and with supporting evidence through the portal. Assign a regulatory lead to monitor the SUGAM portal daily for query notifications, since response timelines directly affect the overall application timeline.
For MD5 and MD9 manufacturing license applications, CDSCO regulatory officials may conduct a facility inspection to verify that the manufacturing processes, quality management systems, personnel qualifications, and facility infrastructure declared in the Plant Master File and Device Master File are accurate and operationally in place. For Class C rehabilitation device manufacturers — particularly those producing electrical stimulation systems or powered rehabilitation robotics — the inspection will cover calibration records for test equipment, electronics assembly quality controls, and GMP compliance across the manufacturing process. Conduct a rigorous pre-inspection internal audit using the PMF as the inspection checklist.
Once all CDSCO criteria are satisfied — all documents verified, queries resolved, and inspection findings (where applicable) cleared — the applicable rehabilitation medical device license is granted through the SUGAM portal: Form MD5, MD9, or MD15. Review the license details carefully on receipt to confirm that every device name, facility address, and applicant entity name is accurately reflected. Any discrepancies should be flagged to the issuing authority immediately for correction before commencing commercial manufacture or import activity under the license.
License Validity and Retention Fee Requirements
The CDSCO rehabilitation medical device license is valid indefinitely from the date of grant — there is no fixed expiry date on the license itself. This indefinite validity provides long-term regulatory stability for manufacturers and importers who have built their commercial operations around a licensed rehabilitation device portfolio.
| Parameter | MD5 — Class A/B Manufacture | MD9 — Class C Manufacture | MD15 — Import All Classes |
|---|---|---|---|
| Validity | Indefinite | Indefinite | Indefinite |
| Retention fee cycle | Every 5 years | Every 5 years | Every 5 years |
| Effect of non-payment | Automatic cancellation | Automatic cancellation | Automatic cancellation |
| Issuing authority | State Licensing Authority | CDSCO (Central) | CDSCO (Central) |
| Initial license fee | Rs. 5,000 + Rs. 500/device | Rs. 50,000 + Rs. 1,000/device | Class-dependent |
5 Benefits of CDSCO Licensing for Rehabilitation Device Manufacturers
A valid CDSCO license is the legal gateway to India's rehabilitation medical device market — a market structurally driven by population ageing, rising stroke and injury rehabilitation needs, and expanding physiotherapy and sports medicine infrastructure. Without a valid CDSCO license, neither manufacture nor import of notified rehabilitation devices is legally permissible in India. Obtaining the license converts growing market demand into legally accessible commercial opportunity.
Physiotherapists, rehabilitation physicians, and hospital procurement teams are clinically attentive to the safety and consistency of devices used in patient recovery programmes. CDSCO licensing — backed by ISO 13485 quality management certification and comprehensive Device Master File documentation — signals that a manufacturer's electrical stimulation systems or rehabilitation robotics have been assessed against a verified safety and quality standard, supporting trust-based commercial relationships in a clinically sensitive specialty.
India's public rehabilitation infrastructure — including district hospital physiotherapy departments and national disability rehabilitation initiatives — procures rehabilitation devices through government and empanelled facility channels. CDSCO licensing is a mandatory eligibility requirement for government procurement participation. Manufacturers with a valid MD5 or MD9 license gain access to this substantial public procurement channel, while unlicensed competitors are excluded regardless of product quality.
Rehabilitation devices imported without a valid CDSCO MD15 license face customs detention and potential seizure. For healthcare facilities dependent on reliable supplies of electrotherapy equipment, rehabilitation robotics components, or therapy consumables, customs delays directly affect clinical operations. A valid MD15 license ensures consistent, uninterrupted customs clearance — protecting the supply continuity that hospital procurement departments and clinical teams depend on.
Rehabilitation device demand in India is structurally durable — driven by demographic ageing and a growing public health emphasis on functional recovery that is independent of economic cycles. A CDSCO license with indefinite validity provides the long-term regulatory foundation from which manufacturers can grow their rehabilitation device portfolio — adding new electrotherapy products, biofeedback systems, or robotic therapy devices to the license through variation applications as the business scales.
CDSCO General Hospital Medical Device License India 2026 — Complete Guide
Rehabilitation device manufacturers whose portfolio also includes general hospital equipment — patient monitoring systems, hospital beds, mobility equipment, or therapy support systems used across clinical departments — should review the CDSCO licensing requirements for the general hospital device category. These requirements apply alongside rehabilitation-specific licensing and may enable consolidation of multi-category product portfolios under a coordinated licensing strategy.
How Rego Services Supports Your CDSCO Application
Securing the CDSCO rehabilitation medical device license is a substantial undertaking — particularly for Class C devices such as pulsed signal therapy systems, foot sensorimotor therapy mechanical neurostimulators, and interferential electrical stimulation systems, where the technical depth of the Device Master File and the intensity of the Central Licensing Authority review require considerable regulatory expertise. Rego Services Private Limited provides end-to-end support for CDSCO rehabilitation medical device license applications across all notified device classes and license types.
- Device classification confirmation and licensing strategy — We confirm the CDSCO class of your specific rehabilitation device configuration against the 60-device notified list, identify the correct license type (MD5, MD9, or MD15), and assess whether an MD13 test license is required before the permanent license application — structuring the pathway correctly from the outset.
- ISO 13485 certification support — Where ISO 13485 certification is not yet in place, we support the full certification process — QMS gap analysis, documentation development, implementation support, and certification body coordination — on a timeline aligned with the CDSCO license application, with scope language correctly covering the rehabilitation device manufacturing activities.
- Device Master File preparation — We prepare CDSCO-compliant Device Master Files for rehabilitation devices across all classes, with particular attention to the output current accuracy, electrode safety, and programmable parameter validation data required for Class C electrical stimulation systems and the safety interlock documentation required for powered rehabilitation robotics applications.
- Plant Master File preparation — We prepare Plant Master Files that accurately describe the manufacturing facility in the level of detail CDSCO reviewers and inspectors expect, including GMP compliance evidence, equipment calibration records, and electronics assembly process documentation appropriate for the risk class of the rehabilitation device being licensed.
- Batch production and Certificate of Analysis support — We support the planning, documentation, and coordination of the three consecutive production batch runs and their performance testing required as mandatory evidence for MD5 and MD9 applications.
- SUGAM portal submission management — We manage the complete online application process — form selection, field completion, document upload in the correct format, fee payment coordination, and formal submission — eliminating procedural errors that delay the review clock starting.
- Query response and facility inspection preparation — We draft responses to CDSCO reviewer queries, and prepare manufacturing facilities for CDSCO inspection through mock inspection exercises that reflect documented inspection patterns for rehabilitation device applications across all classes.
- Post-grant compliance and retention fee management — We maintain retention fee compliance calendars and support ongoing CDSCO compliance after license grant, helping manufacturers and importers avoid the automatic cancellation risk associated with missed retention fee deadlines, and managing license variation applications as product portfolios expand.
Frequently Asked Questions
Why does CDSCO have no Class D rehabilitation medical device, when most other categories include one?
CDSCO's classification system assigns Class D to devices that are permanently implanted, directly sustain a critical physiological function, or carry the highest possible patient risk if they fail. Rehabilitation medical devices, by design, support recovery through external, non-implantable means — even the most sophisticated devices in the category, such as powered rehabilitation robotics and interferential electrical stimulation systems, operate on the surface of the body rather than inside it, and assist function rather than directly sustaining a vital process. This is why the rehabilitation category tops out at Class C, with the MD9 manufacturing license representing the most demanding regulatory pathway available in this device category, rather than the Class D pathway seen in categories such as cardiovascular implants or certain ophthalmic devices.
Can a single MD9 license cover multiple Class C rehabilitation devices — for example, a pulsed signal therapy system and an interferential electrical stimulation system?
Yes. A single MD9 license can cover multiple Class C rehabilitation devices, provided each product is separately declared in the Form MD9 application and the Device Master File contains a product-specific section for each device — since a pulsed signal therapy system and an interferential electrical stimulation system are distinct devices with different intended uses, output parameters, and applicable performance standards. Each additional device declared in the application attracts the per-device fee of Rs. 1,000. Adding new Class C rehabilitation devices after the initial MD9 is granted requires a variation application to CDSCO Central, not a fresh license application.
Does importing a continuous passive motion (CPM) device for rehabilitation use require the same MD15 license as importing a pulsed signal therapy system?
Yes — both require a valid MD15 import license from CDSCO regardless of their different risk classes (a continuous passive motion device is typically Class B; a pulsed signal therapy system is Class C). However, since different classes carry different fee structures under the MD15 pathway, confirm the applicable fee for each specific device before submitting the import license application. If your import portfolio spans multiple rehabilitation device types and classes, all devices can be covered under a single MD15 license provided each is declared as a separate product entry with its own product-specific documentation.
What performance testing standards apply to electrical stimulation rehabilitation devices for the CDSCO MD9 application?
Electrical stimulation devices used in rehabilitation — including interferential electrical stimulation systems and foot sensorimotor therapy neurostimulators — must comply with applicable IEC and ISO standards referenced under MDR 2017, including IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment), IEC 60601-1-2 (EMC requirements), and IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) where applicable. Testing must be performed by accredited testing laboratories, and the test reports must be included in the Device Master File submitted with the MD9 application. Rego Services advises on the current applicable standards for each Class C rehabilitation device category as part of the DMF preparation process.
How does India's growing stroke and road traffic injury burden affect demand for Class C rehabilitation devices?
Rising stroke incidence and a persistently high road traffic injury burden in India are directly increasing clinical demand for advanced neuromuscular rehabilitation technologies — particularly functional electrical stimulation systems for gait correction and powered rehabilitation robotics used in motor relearning therapy. For manufacturers holding a valid MD9 license for these Class C devices, this creates access to a growing rehabilitation hospital and neuro-rehabilitation centre procurement channel that is exclusively available to CDSCO-licensed manufacturers. For companies entering the advanced neuro-rehabilitation device space, obtaining the MD9 license early is critical to capturing this expanding clinical demand.
✓ Key Takeaways
- Demand for rehabilitation medical devices in India is rising sharply, driven by an ageing population, rising stroke incidence, road traffic injury rehabilitation needs, and expanding physiotherapy and sports medicine infrastructure
- CDSCO notified 60 rehabilitation medical devices on 13 September 2021, classified across Class A, B, and C only — there is no Class D device in this category, unlike most other CDSCO device categories
- License types: MD5 (manufacture Class A/B — State Licensing Authority, Rs. 5,000 + Rs. 500/device), MD9 (manufacture Class C, the highest notified tier — CDSCO Central, Rs. 50,000 + Rs. 1,000/device), and MD15 (import all classes — CDSCO Central)
- All license types are valid indefinitely — but the retention fee must be paid every 5 years, or the license is automatically cancelled without the possibility of reinstatement through late payment
- ISO 13485 certification and a comprehensive Device Master File — with particular emphasis on output current accuracy and electrode safety data for Class C electrical stimulation systems — are mandatory for all manufacturing license applications
- The CDSCO application process follows 5 structured steps: document preparation, SUGAM portal submission, query resolution, facility inspection (for manufacturing licenses), and license approval
- First-time manufacturers needing initial batch data will require an MD13 test license before applying for the permanent MD5 or MD9 license — this must be factored into the overall regulatory timeline
- A single MD9 license can cover multiple Class C rehabilitation devices — new products added after license grant require a variation application to the issuing authority
Your Next Step
Rehabilitation medical devices occupy a clinically and commercially important position in India's healthcare system — supporting a growing patient population recovering from stroke, surgery, sports injury, and chronic musculoskeletal conditions. The CDSCO licensing framework reflects the distinctive risk profile of this category: with no Class D device, the MD9 pathway for Class C devices represents the most demanding regulatory route available, and getting this classification right from the outset is the foundation of a compliant, efficient market entry.
Rego Services' regulatory team brings deep familiarity with CDSCO's requirements across the full rehabilitation device spectrum — from Class A thermal therapy packs through Class B mobility and exercise equipment to the Class C electrical stimulation and rehabilitation robotics systems that represent the highest regulatory bar in this category. With our support, the path from device classification through ISO 13485 certification, Device Master File and Plant Master File preparation, SUGAM portal submission, and license grant is a structured, well-managed process rather than the complex and time-consuming challenge it can be without experienced regulatory guidance.
Contact Rego Services today to confirm your rehabilitation device's CDSCO classification, identify the correct license type, and receive a device-specific regulatory plan with a realistic timeline for your India market entry.