A CDSCO general hospital medical device license is mandatory under India's Medical Devices Rules, 2017 for any manufacturer or importer of notified general hospital devices — equipment used by healthcare professionals to administer treatment and provide patient care across hospital and secondary care settings. General hospital devices span Class A through Class C (and some Class D). Manufacturing Class A and B devices requires a Form MD5 license from the State Licensing Authority (fee: Rs. 5,000 plus Rs. 500 per device). Manufacturing Class C and D devices 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 three license types are valid indefinitely, subject to a retention fee paid every 5 years. Applications are submitted through the CDSCO SUGAM portal (cdscoonline.gov.in). ISO 13485 certification and a Device Master File are mandatory for all manufacturing license applications.
General hospital medical devices form the operational backbone of every hospital and secondary care facility in India. From the hospital bed on which a patient rests, to the sterilizer that renders surgical instruments safe for reuse, to the neonatal incubator that sustains a premature infant's life — this broad category of devices underpins the delivery of healthcare at every level of the system. Their reliability, safety, and consistent performance are core requirements of patient care, not peripheral considerations.
India's Central Drugs Standard Control Organisation (CDSCO) recognises this through the mandatory licensing framework established under the Medical Devices Rules, 2017. Every manufacturer and importer of notified general hospital medical devices must hold a valid CDSCO license before placing those devices on the Indian market. This guide provides the complete picture — from understanding what the general hospital device category covers, through classification, license selection, document preparation, and the 6-step SUGAM application process, to the common challenges that applicants face and how to overcome them.
📑 Quick Navigation
- What Are General Hospital Medical Devices?
- CDSCO Regulation Under MDR 2017
- CDSCO Classification: General Hospital Devices by Class
- Three CDSCO License Types: MD5, MD9, MD15
- License Validity and Retention Fee Requirements
- Mandatory Documents for CDSCO General Hospital Device License
- 6-Step Application Process Through CDSCO SUGAM
- Common Application Challenges and How to Overcome Them
- 5 Benefits of CDSCO Licensing for General Hospital Device Manufacturers
- How Rego Services Supports Your CDSCO Application
- Frequently Asked Questions
What Are General Hospital Medical Devices?
General hospital medical devices are medical devices used by healthcare professionals to administer treatment and provide patient care in hospital environments and secondary care settings. They represent one of the most expansive and functionally diverse categories in CDSCO's notified device classification — spanning simple non-powered equipment like patient scales and hospital beds through critical active devices like sterilization systems, infant radiant warmers, and neonatal incubators.
Their defining characteristic is their role in supporting the basic clinical functions of any hospital: patient positioning, monitoring, temperature measurement, blood collection and handling, infection prevention through sterilization, patient transport, and neonatal care. General hospital devices are required not only in tertiary hospitals with advanced surgical capabilities but also in secondary care units, community health centres, and primary healthcare facilities throughout India. Their ubiquity across the system makes the quality and safety of these devices a public health matter.
CDSCO Regulation Under MDR 2017
The Central Drugs Standard Control Organisation (CDSCO) is India's apex regulatory body for medical devices. Under the Medical Devices Rules, 2017, CDSCO has notified a comprehensive schedule of medical device categories — including general hospital medical devices — that are subject to mandatory licensing. The MDR 2017 framework requires every manufacturer operating from an Indian facility and every importer bringing notified devices into India for commercial sale to hold a valid license before any device enters the market.
CDSCO's regulatory objective for this category is precise: to ensure that only high-quality, safe, and effective general hospital devices reach Indian healthcare facilities, and to establish a framework of accountability that gives hospitals, clinicians, and patients confidence in the devices they use every day. This is pursued through pre-market licensing — assessing quality systems, manufacturing processes, and device technical documentation before commercial supply begins — and post-market surveillance, which continues after the license is granted.
CDSCO Classification: General Hospital Devices by Class
The Medical Devices Rules, 2017 classify all notified medical devices into four risk-based classes — A (lowest) through D (highest). The classification of a general hospital device depends on its intended purpose, mechanism of action, duration and nature of body contact, and whether it is powered or non-powered. The class determines which license applies, which authority issues it, and what the associated regulatory requirements are. The following covers the three classes most commonly encountered in the general hospital device category.
- Bed exit monitor / fall prevention device
- Stand-on and standard patient scale
- Clinical colour change thermometer
- Apgar timer
- Hydraulic adjustable hospital bed
- Manual adjustable hospital bed
- Nonpowered flotation therapy mattress
- Therapeutic medical binder & burn sheet
- Neonatal eye pad
- Cardiopulmonary resuscitation board
- Blood grouping slides & bank pipettes
- Blood bank centrifuge
- Blood mixing and weighing devices
- Hand-carried stretcher
- Liquid crystal forehead temperature strip
- Electrically powered spinal fluid pressure monitor
- Spinal fluid manometer
- Sterilization process indicator (biological)
- Sterilization process indicator (physical / chemical)
- Clinical electronic thermometer
- Clinical mercury thermometer
- Medical bassinet & paediatric crib
- Pressure infusor for IV bag
- Intravascular admin set with air removal
- Patient care reverse isolation chamber
- Blood Vacutainer
- Electronic monitor for gravity flow infusion systems
- Infant radiant warmer
- Neonatal incubator
- Neonatal transport incubator
- Jet lavage system
- Ethylene oxide (EO) gas sterilizer
- Dry-heat sterilizer
- Steam sterilizer (autoclave)
- Liquid chemical sterilants / high level disinfectants
- Medical washer-disinfector
- Hydrogen peroxide gas plasma sterilization system
- Wheeled stretcher
- These examples are illustrative — not exhaustive
- Classification depends on the declared intended use, not physical form alone
- The same device type may differ by class based on sterility, power source, or contact duration
- Always verify against the MDR 2017 published schedule before selecting a license type
- Rego Services confirms CDSCO classification as the first step in every licensing engagement
Three CDSCO License Types: MD5, MD9, MD15
Three distinct CDSCO license types apply to general hospital medical devices, determined by whether the applicant is manufacturing or importing and — for manufacturers — the risk class of the specific device. Identifying the correct license type before preparing documents is essential: each type has different government fees, different reviewing authorities, and different mandatory document requirements.
CDSCO Medical Device Test License (MD13 / MD17) India 2026 — Complete Guide
If you are a first-time manufacturer of general hospital medical devices and need to produce the three consecutive batch Certificate of Analysis required for your MD5 or MD9 application, an MD13 test license is the legally required first step. This guide covers the full test license process — mandatory documents, the 5-step SUGAM application, and validity rules.
License Validity and Retention Fee Requirements
CDSCO general hospital medical device licenses — MD5, MD9, and MD15 — are issued with indefinite validity under the Medical Devices Rules, 2017. There is no fixed expiry date that triggers a full renewal application. However, indefinite validity is conditional on payment of a license retention fee every five years. If the retention fee is not paid before the due date, the license may lapse, and reinstatement may require a completely fresh application with the full document set, fees, and review timeline.
| Parameter | MD5 — Class A/B Manufacture | MD9 — Class C/D Manufacture | MD15 — Import All Classes |
|---|---|---|---|
| Validity period | Indefinite | Indefinite | Indefinite |
| Retention fee cycle | Every 5 years | Every 5 years | Every 5 years |
| Effect of non-payment | License may lapse; fresh application may be required | License may lapse; fresh application may be required | License may lapse; fresh application may be required |
| 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 |
Mandatory Documents for CDSCO General Hospital Device License Application
The document requirements are defined under the Medical Devices Rules, 2017 and CDSCO's associated guidance. The precise set varies by license type and device class, but the following core mandatory documents apply across MD5, MD9, and MD15 applications. The quality and completeness of this document set is the single largest determinant of how quickly the application moves through the CDSCO review process — and whether it generates queries that extend the timeline.
- Organisation identity proof — Certificate of Incorporation, Memorandum and Articles of Association, GST registration certificate, and other applicable entity identity documents establishing the legal standing of the applicant company.
- Sale Deed or Rent Agreement for the declared premises — Valid documentary evidence of the applicant's right to occupy the manufacturing facility (for MD5/MD9) or the registered office or warehouse (for MD15). Documents must be current and in the name of the applicant entity.
- Building layout plan with dimensions — An accurate, dimensioned floor plan of the manufacturing facility showing production zones, quality control laboratory, storage areas, personnel facilities, and utility infrastructure. For Class C and D general hospital devices, the layout must demonstrate GMP-compliant facility design consistent with ISO 13485 requirements.
- Qualified and experienced personnel documentation — Curriculum vitae, educational qualifications, and appointment letters for the technical team responsible for manufacturing, quality control, and quality assurance. CDSCO specifies minimum qualification levels for key personnel — the documentation must demonstrate that these requirements are met for the specific device category.
- Device Master File (DMF) — A comprehensive technical dossier covering the device's design documentation, intended use, manufacturing process, risk management file (per ISO 14971), testing and performance data, biocompatibility data (where applicable), labelling and Instructions for Use, and post-market surveillance plan. The DMF is the most technically demanding document in the application set — its quality directly determines whether the application progresses smoothly or generates extended reviewer queries.
- Plant Master File (PMF) — A comprehensive document describing the manufacturing facility: location, physical layout, manufacturing process flows, equipment inventory with calibration and maintenance schedules, cleaning and sanitation procedures, environmental monitoring programme, personnel structure, and quality management infrastructure. For Class C and D general hospital devices, the PMF must provide evidence of GMP compliance aligned with ISO 13485.
- ISO 13485 Certificate — A current, in-scope ISO 13485 certificate from an IAF-accredited certification body. The certificate's scope must cover the manufacturing or quality management activities relevant to the general hospital device being licensed. This is a mandatory hard requirement for all MD5 and MD9 applications — the application cannot proceed without it.
- Test License (if applicable) — Where the three consecutive batch Certificate of Analysis data was produced under a CDSCO MD13 test license, a copy of that license must be included to confirm the batch production was lawfully authorised before the permanent license was in place.
- Certificate of Analysis for three consecutive production batches — Documentary proof that the manufacturing process consistently produces general hospital devices that conform to declared specifications. For first-time manufacturers, these batches must be produced under a valid MD13 test license. The CoA data is the core technical evidence supporting the permanent license grant.
- Environmental regulation compliance documents — For manufacturers whose process generates regulated waste streams — particularly relevant for sterilization system manufacturers where EO gas or chemical sterilants are involved — applicable Pollution Control Board clearances and waste disposal agreements must be included.
Of all mandatory documents, the Device Master File and Plant Master File account for the largest proportion of CDSCO reviewer queries in general hospital device license applications. Both should be treated as priority workstreams started in parallel with ISO 13485 certification — since the QMS documentation developed during certification directly feeds the PMF and portions of the DMF. Companies that complete ISO 13485 certification before beginning the DMF and PMF in earnest routinely add three to four months to their overall licensing timeline unnecessarily.
ISO 13485 Certification in India 2026 — Complete Guide
ISO 13485 certification is mandatory for all CDSCO manufacturing license applications for general hospital medical devices. This guide covers all 8 ISO 13485 clauses, the 10-step certification process, and how Rego Services supports manufacturers through gap analysis, QMS documentation, implementation, and certification body audit preparation — on a timeline coordinated with the CDSCO license application.
6-Step Application Process Through CDSCO SUGAM
All CDSCO general hospital medical device license applications — MD5, MD9, and MD15 — are submitted, managed, and resolved through the CDSCO SUGAM online portal at cdscoonline.gov.in. The portal handles document upload, fee payment, query correspondence, inspection scheduling, and license issuance.
Identify which CDSCO class your general hospital device belongs to under the MDR 2017 schedule. The class determines the license type (MD5, MD9, or MD15), the reviewing authority (State or Central), and the applicable fee structure. Misclassification requires a restart of the application and wastes both fees and document preparation effort. Rego Services performs a formal classification confirmation as the mandatory first step in every licensing engagement.
Compile all required documents: organisation identity proof, premises documents, building layout plan, qualified personnel documentation, Device Master File, Plant Master File, ISO 13485 certificate, Certificate of Analysis for three consecutive batches, test license (if applicable), and environmental compliance documents. Conduct an internal document review for completeness and consistency across the full set before proceeding to portal submission. Applications submitted with gaps consistently take longer to resolve than applications submitted complete.
Create a company account or log in at cdscoonline.gov.in. Ensure all entity details on the portal — legal entity name, registered address, GST number — exactly match the identity documents submitted. Select the applicable form (MD5, MD9, or MD15) and upload all mandatory documents in the required file formats and sizes. Verify every uploaded document against the portal's specifications before proceeding to the payment step.
Pay the applicable government fee through the SUGAM portal. MD5: Rs. 5,000 plus Rs. 500 per distinct general hospital device covered. MD9: Rs. 50,000 plus Rs. 1,000 per distinct device. Payment constitutes formal submission — prior to payment, the application is in draft and has not been received by the reviewing authority. Retain the digital payment receipt and application reference number for all subsequent tracking and correspondence.
The licensing authority reviews the application and may raise written queries through the SUGAM portal. These must be addressed accurately and within the specified timeframe. For MD5 and MD9 manufacturing license applications, CDSCO regulatory officials typically conduct a physical facility inspection before the license is granted — verifying that manufacturing infrastructure, quality systems, and personnel qualifications are consistent with the Plant Master File and Device Master File declarations. Preparation for this inspection is a defined activity, not an afterthought.
Once all criteria are satisfied — queries resolved and inspection findings cleared — the CDSCO license is issued through the SUGAM portal. Post-grant obligations include maintaining ISO 13485 certification, fulfilling adverse event reporting requirements, maintaining the post-market surveillance programme, and paying the license retention fee every five years. CDSCO may conduct post-market surveillance inspections without advance notice at any point during the license period.
Common Application Challenges and How to Overcome Them
Three categories of challenge account for the majority of delays and complications in CDSCO general hospital medical device license applications. Understanding these challenges — and preparing to address them proactively before submission — is consistently more effective than managing them reactively after queries are raised or inspection findings are reported.
5 Benefits of CDSCO Licensing for General Hospital Device Manufacturers
A valid CDSCO license is the non-negotiable legal prerequisite for placing general hospital medical devices on the Indian market. Without it, manufacture or import for commercial sale is prohibited under the Medical Devices Rules, 2017 — exposing the company to enforcement action under the Drugs and Cosmetics Act. Obtaining the license is not optional: it is the regulatory gateway without which no compliant commercial activity in this device category can begin. India's healthcare infrastructure is expanding significantly, creating sustained demand that only licensed manufacturers and importers can meet.
Hospital procurement managers — across private hospital groups, government health institutions, and corporate healthcare systems — increasingly scrutinise supplier regulatory credentials as part of vendor qualification. A valid CDSCO license signals that your general hospital devices have been evaluated against mandatory Indian regulatory standards and that your quality management system is ISO 13485 certified. This credibility differentiates licensed suppliers from unlicensed competitors and supports long-term procurement relationships with major Indian hospital groups.
General hospital devices imported without a valid CDSCO MD15 license face customs detention, potential seizure, and costs associated with re-export or destruction of goods. A valid MD15 license provides customs authorities the documentary authorisation required to clear shipments of notified general hospital devices. For importers supplying hospitals with time-sensitive equipment such as neonatal incubators or sterilization consumables, customs delays are not just administrative inconveniences — they disrupt hospital procurement schedules and damage commercial relationships.
A substantial share of general hospital medical device procurement flows through government channels — central and state government hospital tenders, AYUSHMAN BHARAT empanelled hospital supply, National Health Mission equipment programmes, and central government health facility supply schemes. CDSCO licensing is a mandatory eligibility criterion for participation in these procurement processes. Companies without a valid license are ineligible regardless of price or product quality. The CDSCO license is both a regulatory requirement and a commercial prerequisite for accessing India's large and growing public healthcare procurement market.
A CDSCO license with indefinite validity provides a stable regulatory foundation from which to build and scale an India business over time — adding new device models, expanding distribution networks, engaging new hospital customers, and responding to tenders — without the uncertainty of periodic full license renewal. Manufacturers and importers who establish and maintain CDSCO compliance early build a regulatory position that becomes a durable competitive advantage as India's general hospital device market continues to expand alongside the country's healthcare infrastructure.
CDSCO Operation Theatre Medical Device License India 2026 — Complete Guide
Many manufacturers supply both general hospital devices and operation theatre devices — categories that frequently appear together in hospital procurement. If your portfolio includes OT devices (surgical tables, electrosurgical units, anaesthesia machines, or surgical instruments), this guide covers the specific classification, license types, mandatory documents, and application requirements for OT devices under MDR 2017.
How Rego Services Supports Your CDSCO Application
Rego Services Private Limited provides end-to-end support for CDSCO general hospital medical device license applications — MD5 (Class A and B manufacturing), MD9 (Class C and D manufacturing), and MD15 (import) — across all general hospital device categories from hospital beds and thermometers through neonatal incubators and sterilization systems. Our regulatory team combines deep knowledge of CDSCO document requirements with practical experience of what State Licensing Authority and CDSCO Central reviewers examine most closely in general hospital device applications.
- Device classification confirmation and licensing strategy — We confirm the CDSCO class of your general hospital device under the MDR 2017 schedule, identify the applicable license type, and develop a complete regulatory strategy — including whether an MD13 test license is required before the permanent license, how ISO 13485 certification fits into the overall timeline, and what the realistic timeline to license grant looks like for your specific situation.
- ISO 13485 certification support — Where ISO 13485 certification is not yet in place, we support the complete certification process — gap analysis, QMS documentation development, implementation support, internal audit preparation, and certification body audit liaison — on a timeline coordinated with the CDSCO license application to avoid sequential delays.
- Device Master File preparation — We prepare comprehensive, CDSCO-compliant DMFs for general hospital devices across all classes — covering device description, design documentation, risk management files, testing and performance data, biocompatibility summaries, labelling and Instructions for Use, and post-market surveillance plans tailored to the specific device type.
- Plant Master File preparation — We prepare PMFs that accurately and completely describe the manufacturing facility in the format and level of detail CDSCO reviewers and inspectors expect — covering facility layout, process flows, equipment inventory, calibration and maintenance programmes, cleaning and sanitation, environmental monitoring, and quality management infrastructure.
- Three consecutive batch Certificate of Analysis support — We support the planning, documentation, and compilation of the three consecutive batch data required for MD5 and MD9 applications, ensuring batch records are maintained to the standard that CDSCO reviewers and inspectors will assess.
- SUGAM portal submission management — We manage the complete online application process — portal registration verification, form selection, document upload, fee payment, and formal submission — eliminating the procedural errors that delay the start of the reviewing authority's clock.
- Query response management — We draft and coordinate responses to CDSCO reviewer queries, drawing on our knowledge of common query patterns in general hospital device applications to provide direct, evidence-based replies that advance the review efficiently.
- Mock inspection preparation — For manufacturing license applications, we conduct mock CDSCO facility inspection exercises that mirror the regulatory inspection protocol — identifying facility gaps, documentation weaknesses, and personnel readiness issues in advance so they can be corrected before official inspection.
- Post-grant compliance and retention fee management — We support ongoing compliance after license grant: maintaining retention fee compliance calendars, supporting adverse event reporting, assisting with the addition of new device models to existing licenses, and providing continuing regulatory guidance as the India business grows.
Frequently Asked Questions
Are hospital beds notified medical devices requiring a CDSCO license?
Yes. Hospital beds are notified under the Medical Devices Rules, 2017 and require a valid CDSCO license for manufacture or import in India. Manual adjustable hospital beds are typically classified as Class A devices, requiring an MD5 manufacturing license from the State Licensing Authority. Hydraulic hospital beds are also generally Class A. Electrically powered hospital beds may be Class B depending on their control systems and functionality. The precise classification of a specific model should be confirmed against the MDR 2017 published schedule before selecting the license type and beginning document preparation.
Are sterilization systems among the most complex general hospital devices to license?
Yes. Sterilization systems — including EO gas sterilizers, steam sterilizers (autoclaves), dry-heat sterilizers, hydrogen peroxide gas plasma systems, and liquid chemical sterilant products — are classified as Class C general hospital devices and require an MD9 manufacturing license from CDSCO Central. The licensing requirements are more demanding than for Class A or B devices: the Device Master File must include sterilization process validation data, the Plant Master File must address safety protocols for hazardous sterilant agents, and environmental compliance documentation is mandatory where regulated chemical waste streams are generated. Rego Services has experience supporting MD9 applications specifically for sterilization system and disinfectant manufacturers.
Can a single CDSCO license cover general hospital devices across different classes?
No. Class A and B general hospital devices are licensed under MD5 (State Licensing Authority) and Class C and D devices under MD9 (CDSCO Central). These are distinct license types with different reviewing authorities — a single license cannot span both tiers. A manufacturer whose portfolio spans Class A/B and Class C/D devices must hold separate MD5 and MD9 licenses. The two applications can be prepared concurrently to reduce elapsed time, though they will be reviewed independently. Rego Services coordinates parallel license applications where multiple license types are needed for a single portfolio.
Does a US FDA clearance or CE mark substitute for a CDSCO license in India?
No. A US FDA clearance, CE mark, or equivalent foreign regulatory approval does not substitute for a CDSCO license under the Medical Devices Rules, 2017. Every manufacturer or importer of notified general hospital devices in India must hold a valid CDSCO MD5, MD9, or MD15 license, regardless of any other regulatory authorisations the device holds internationally. For MD15 import license applications, foreign marketing authorisations are typically required as supporting documents — but they do not replace the Indian license requirement.
How long does it take to obtain a CDSCO general hospital medical device manufacturing license?
Realistic timelines depend on the device class and the starting point of the applicant's regulatory journey. For a company starting without ISO 13485 certification, Device Master File, or Plant Master File, a reasonable overall timeline for an MD5 license (Class A or B) is 8 to 14 months — accounting for ISO 13485 certification (4 to 9 months), document preparation, the test license if required, and CDSCO review. For MD9 (Class C) general hospital devices, the timeline is typically 12 to 18 months or more, given the more demanding document requirements and the central review process. Rego Services provides device-specific timeline assessments as part of every initial regulatory strategy engagement.
✓ Key Takeaways
- General hospital medical devices are notified under the Medical Devices Rules, 2017 — a mandatory CDSCO license is required for all manufacturers and importers before any notified general hospital device can be placed on the Indian market
- General hospital devices primarily span Class A, B, and C — examples include hospital beds and blood bank equipment (A), electronic thermometers and sterilization indicators (B), and neonatal incubators, steam sterilizers, and infusion monitors (C)
- Three license types apply: MD5 (manufacture Class A/B — State Licensing Authority, Rs. 5,000 + Rs. 500/device), MD9 (manufacture Class C/D — CDSCO Central, Rs. 50,000 + Rs. 1,000/device), and MD15 (import all classes — CDSCO Central)
- All three license types have indefinite validity, subject to a retention fee paid every 5 years — a missed payment may result in license lapse and requirement for a fresh application
- ISO 13485 certification is mandatory for all MD5 and MD9 manufacturing license applications — it must be in place before the application can be submitted
- The Device Master File and Plant Master File are the most complex mandatory documents and the primary source of CDSCO reviewer queries — preparing them rigorously and early is the most effective strategy for compressing time to license grant
- The three most common challenges — documentation gaps, query resolution delays, and inspection hurdles — are all best addressed through thorough preparation before submission, not reactive management after they arise
- First-time manufacturers needing to produce initial batch data will likely require an MD13 test license before the permanent manufacturing license application — this must be factored into the overall timeline from the outset
Your Next Step
General hospital medical devices are the foundation of everyday patient care across India — and the CDSCO licensing framework reflects their importance. For manufacturers of hospital beds, thermometers, blood bank equipment, neonatal incubators, and sterilization systems, and for importers bringing international general hospital technology into the Indian market, the CDSCO license is the documented proof that your devices and your operations meet the standards India's healthcare system requires.
The path to that license — from device classification confirmation through ISO 13485 certification, Device Master File and Plant Master File development, batch production data, SUGAM portal submission, query management, and facility inspection — is a structured process that rewards careful planning and expert preparation. The three most common challenges (documentation gaps, query delays, and inspection findings) are all predictable and preventable with the right preparation. Companies that invest in getting the fundamentals right at each stage consistently achieve faster licensing timelines and stronger compliance foundations than those who treat the application as a routine administrative task.
Rego Services' regulatory team has supported manufacturers and importers of general hospital medical devices across all CDSCO device classes through the full licensing process — from first engagement through license grant and ongoing post-grant compliance. Our approach is built on thorough document preparation, proactive query management, and practical inspection readiness — the three factors that most directly determine licensing speed and outcome.
Contact Rego Services today to discuss your CDSCO general hospital medical device license requirements and receive a device-specific regulatory plan with a realistic, honest timeline for your India market entry.