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- To register Class C and D medical devices, manufacturers must obtain Central Drugs Standard Control Organization (CDSCO) approval, which has strict documentation and quality management system requirements.
- Compliance to the licensing process ensures that the medical device is safe for consumers and it is allowed to be sold legally in the Indian market. It also contributes to building trust with hospitals and distributors across India’s healthcare ecosystem.
- Failure to follow the registration guidelines fully increases the likelihood of market delays, import rejections, or legal penalties, which is often associated with inaccurate documentation or misclassification of the medical device.
- Given these are C and D devices, which are considered moderate to high-risk devices; thus, more attention must be directed to verifying the device master file, verifying the plant master file, and clinical evaluation reports along with order and packaging compliance.
Introduction
Our regulatory team was contacted last month by a promising Indian medtech startup with a serious issue. With funding in hand, they had developed an innovative cardiac monitoring device, but have spent eight months without successful market entry. The startup had misunderstood the significance of class C and D medical device registration requirements under CDSCO guidelines and had only recently realized these requirements would be more involved than they anticipated.
This device was classified as level C due to moderate patient risk and required rigorous clinical validation, accompanying ISO 13485 certification, and extensive safety documents – which they had not been able to gather. This challenge limited their opportunity to not just time, but a potential partner with a large hospital chain that indicated outright that they only contracted devices and technologies that were registered devices.
Understanding Class C and D Medical Devices
CDSCO Classification Framework
India’s risk-based medical device classification system was instituted under the Medical Device Rules 2017 and is divided into four distinct classes of products. This classification scheme assists CDSCO to determine the priority for regulatory oversight based on risk or possible consequence to the patient.
Class A devices are of low risk and include basic instruments such as a stethoscope or exam gloves. Class B devices are of low to moderate risk, such as electrocardiogram (ECG) machines or blood pressure monitors. Risk Classes C and D offer moderate to high risk and require strict regulatory oversight.
Class C devices include moderate risk to patients, even those that may cause slight injury to a person if the device were to fail. Class D defines the highest risk level device, which may include life-supporting or life-sustaining devices failures could result in the death or serious injury.
Examples of Class C, D Devices
Cardiac stents, orthopedic implants, infusion pumps, and some imaging devices are examples of devices in Class C. Because they come into direct contact with patient physiology, these devices must demonstrate safety and efficacy prior to entering the commercial marketplace.
The Class D devices include ventilators, pacemakers, defibrillators and implantable devices–Sometimes a company like Medtronic can successfully register their cardiac devices
Class C vs Class D: Key Differences
| Aspect | Class C Devices | Class D Devices |
| Risk Level | Moderate Risk | High/Extreme Risk |
| Patient Impact | Temporary injury if malfunction | Death/serious injury if malfunction |
| Examples | Cardiac stents, infusion pumps, orthopaedic implants, certain MRI systems | Ventilators, pacemakers, defibrillators, heart valves, neurostimulators |
| Clinical Evidence | Clinical data required | Extensive clinical studies mandatory |
| Review Timeline | 6-9 months typical | 8-12 months typical |
| Inspection Frequency | Periodic facility audits | Rigorous pre-approval inspections |
| Post-Market Surveillance | Annual safety reports | Comprehensive monitoring systems |
Why Registration Matters for Class C and D Medical Devices
Legal Compliance Obligations
Under the Medical Device Rules 2017, no Class C or D device can be manufactured, imported or sold in India without legitimate registration with the CDSCO which is not just a bureaucratic formality but a legal requirement, without which both manufacturers/importers and sellers can be subject to significant penalties. Furthermore, trade in unregistered devices can lead to seizure by regulatory authorities or criminal prosecution under the Drugs and Cosmetics Act.
Patient Safety and Liability Risk Management
Medical devices classified as high-risk are fundamentally linked to patient outcomes. Registration ensures that devices comply with safety standards and appropriate risk assessment has taken place. Health care providers and patients cannot, with full confidence, assume that a device is safe and efficacious without proper registration.
Market Access and Reputation Building
Indian hospitals and distributing partners have become much more sophisticated about compliance issues. The majority of large hospital chains are now requiring valid CDSCO registration certificates to even be considered by their procurement committees for devices. A client case history may support this assertion: An international manufacturer of orthopaedic devices inadvertently forfeited a tender for ₹50 crore because the registration had not been completed. The hospital procurement committee had indicated that the performance of clinical functions on the device was impressive and sincere but they simply couldn’t work without the regulatory documentation.
Regulatory Authority and Governing Framework
The CDSCO (Central Drugs Standard Control Organisation), which operates under the Ministry of Health and Family Welfare, is India’s national regulatory authority responsible for medical devices. The CDSCO’s role is to evaluate the safety, efficacy, and quality of medical devices before being granted approval for market access.
The legal framework is based upon the Medical Device Rules 2017, which replaced previous regulations created for drugs with device-specific rules. This regulatory framework brings Indian regulation closer to international regulations whilst still meeting regulatory requirements native to India.
State licensing authorities are also a major component of this regulatory framework, particularly for the granting of manufacturing licenses and local compliance issues. This regulatory framework establishes a system of multi-tiered approvals and inspections whereby central and state authorities have specific approvals and inspections to conduct.
Step-by-Step Registration Process for Class C, D Devices
Step 1 – Device Classification Determination
Manufacturers must first verify the risk classification of their device before starting registration. The CDSCO has established classification guidelines, but if your device is borderline, you may want to formally request classification.
Step 2 – Complete your Dossier
The success of registration depends heavily on the dossier. Class C and D medical devices require complete technical documentation like a description of the device, intended use, risk assessment, and clinical evidence.
Certification for Quality Management Systems (ISO 13485) is a requirement. International manufacturers will typically have CE marking or FDA approval, though additional data may be required that is specific to India.
Clinical investigation reports become especially important for Class D devices. The CDSCO may require Indian clinical data, or it may accept international clinical studies with bridging evidence.
Step 3 – Submitting the Application and Form Information on the CDSCO Portal
All registration applications go through the CDSCO, and all applicants must go through the online SUGAM portal. The information submitted through the portal must include full technical information, documentation about the quality system and fee payment prior to submitting the application.
First-time users may find it difficult to navigate the SUGAM portal. Many manufacturers will use regulatory consultants with experience in SUGAM applications to ensure the application is fully and accurately submitted.
Step 4 – Regulatory Review and Facility Inspection
CDSCO will conduct a desk review and may conduct a facility inspection of the manufacturing site. Validation of the Quality Management Systems to ensure compliance with CDSCO requirements in India will occur.
Most international manufacturers coordinate facilities inspections through their Indian authorised representatives and/or local partners.
Step 5 – Registration Certificate Issuance
Once an application is approved satisfactorily, the CDSCO issues a registration certificate that is valid for a five year period. This registration certificate allows the medical device to be marketed legally in India. The timelines are generally 6-12 months for a complete application; however, when a medical device is complex, or the submission is missing information or is otherwise incomplete, it may take longer to receive a decision.
Essential Documentation for Class C and D Medical device Registration
- Applications for registration must include documentation in specific formats and content.
- The MD-7 form (for Class C) and the MD-8 form (for Class D) are the principal documents for submission.
- Certification for a quality management system in accordance with ISO 13485 shows that the manufacture of the device is in compliance with international quality standards.
- The “The Central Drugs Standard Control Organisation (CDSCO)” requires a current quality management system certificate from a recognized certifying body.
- Having international regulatory approvals, especially CE marking or FDA clearance, will substantially increase the strength of the application.
- The Device Master File and the Plant Master File include all technical and manufacturing information of the medical device.
- Clinical investigation reports serve as evidence of safety and efficacy of the device as determined in a controlled study.
- Risk management documentation, based on the ISO 14971 standard, characterizes the hazard possibilities and outlines the plan to mitigate risk possibilities.
- The post-market surveillance plan is based on updated clinical data standard to outline manufacturer’s procedures to maintain ongoing monitoring of safety.
Fees and Timelines
The fees for registration with CDSCO depend on the device class and the origin of the manufacturer. Additional fee items for consideration include quality system certification, clinical studies (if applicable), and consultant fees.
The registration is valid for 5 years from the date of issue; a renewal application must be submitted before the expiration date. Renewal applications generally are quicker with the urgency in terms of obtaining documents to complete the renewal package, however, they will require updated fee payments and updated documentation.
It seems like “real-life” timelines can vary quite a bit. If the application is well-prepared and the included documents are all in place, the application can be approved in 6-8 months. For a more complex device or if the application submitted is partial, it may take up to 12-18 months for final approval.
How We Succeeded in the Orthopaedic Implant Industry
A European manufacturer of orthopaedic implants consulted our company regarding Indian entry for their new spinal fusion devices. Their Class C devices have been sold successfully in European markets; however, there are challenges in the registration process in India.
The key to the initial problem was converting their CE marking documentation into a submission that would satisfy the CDSCO system in India. Very often, documentation that complies with the use of European devices requires additional biocompatibility data and specific modifications to the labelling not otherwise required in a European market.
We performed a thorough gap analysis of the documentation available for the device and assessed the requirements as they relate to the Indian standards. We compiled the information in order to prepare a submission strategy to cater for specific inquiry of the CDSCO but also leveraging clinical data already collected and tested in their European market.
What happened in the end surprised the client – registration was achieved in 7 months comparing to 12 months they had planned for registration. Effective early planning on a regulatory road map anticipated the expected delay of 6 months for an International manufacturer ready for direct entry. proactive regulatory plan saves time and resources and precision in approach to market entry while remaining compliant to procedure.
Post-Registration Compliance Framework
The start, not the finish, of the regulatory burden is registration. Continuous compliance demonstrates the company’s commitment to maintaining access to the market and patient safety.
Annual safety reporting obligations require certain adverse event and post market surveillance data be reported. CDSCO uses these reports to analyse product performance, and corrective action may be required as a result of safety questions.
Adverse event reporting systems need to collect, review and report on any adverse event associated with the device in a timely manner. The most serious events must be reported immediately to CDSCO.
Facilities need to maintain audit readiness as CDSCO will conduct inspections on a scheduled basis and in coordination with the facility. Quality system maintenance is important and will ensure compliance with ISO 13485, regulatory requirements in India and best practices.
How Diligence Certifications helps in CDSCO Registration
Proper documentation accuracy, or lack thereof, will greatly influence approval success rates. Regulatory visit our site consultants have experience with CDSCO expectations and can catch an issue During the review process, management of queries will prove to be invaluable experience is understanding our site common CDSCO queries and being able to provide in full that approach on both the regulatory area.
If the consulting has been assigned, we have inspector to correspond with immediately if queries arise. Any established working relationships with clients will also substantially influence the length of time to resolve queries or approve an overall project. Lastly, the analogy remains applicable: chartered accountants ensure tax is filed accurately and regulatory consultants ensure regulatory submissions for medical devices are error proof and meet regulatory requirements.
Conclusion
Obtaining registration for a medical device. Class C and D signifies more than just appropriate regulatory compliance. Class C and D registration of the medical device is the initial and most important step to gain access to India’s growing healthcare market.The registration process is a complex, but it is essential in establishing safety for the patient and confidence for healthcare providers, who are favouring regulatory compliance more than ever before.
The investment into proper registration of a Class C and D medical device will pay dividends by allowing access to the market, legal delineation, and a strategic competitive position.
When companies view the registration process in a regulatory-compliant manner with various submissions of accurate documentation, and employ a regulatory-compliant pathway with oversight, their experience is often one of expedited timing and sustainable pathway in the market.
The medical device market in India is expanding due to factors including increased awareness in the healthcare sphere and government cooperation for medical device manufacturing.
This increased activity in the medical device arena is complemented with an protective umbrella of regulatory scrutiny to ensure only safe and effective devices are utilized in the hands of patients.
For medical device manufacturers contemplating the Indian healthcare market, it is critical for them to have early-stage regulatory preparation.
The registration process to obtain market clearance certainly rewards preparation, and punishes those that circumvent or avoid the regulatory process, but also needs to be balanced with having adequate expertise. Speed in getting new, commonplace cardiac device and technology to market (or as in a regulated import of assured European-licensed technologies) depends significantly on the commercialization pathway to market clearance and the registration process.
Ready to Navigate Your Medical Device Registration Journey?
We simplify CDSCO registrations. Our regulatory experts ensure Class C and D medical devices get approved smoothly, without unnecessary delays.
What We Provide:
- Full registration strategy
- Document preparation/review
- Liaison with CDSCO and response to queries
- Timelines and cost savings
- Post-regulatory compliance
- Get a Free Regulatory Assessment
Schedule a conversation with our regulatory experts to discuss your Class C and D medical device registration needs in confidence and we’ll provide you with a detailed timeline and cost estimate and roadmap for your device.
Frequently Asked Questions
What is the difference between a Class C medical device and a Class D medical device?
Class C devices are considered moderate risk (cardiac stents, infusion pumps), Class D devices are considered high risk or life-supporting (ventilators, pacemakers), meaning they can potentially cause death if malfunctioned.
What is the CDSCO turnaround time for approving Class C and Class D medical device registrations?
Class C devices take about 6-9 months, and Class D devices take 8-12 months depending on the completeness of the documentation and regulatory questions.
Can CE or FDA approval be used instead of CDSCO registration for Indian market entry?
No, while having international approvals can strengthen applications, they cannot be used instead of registration in India. All medical devices coming into the Indian market must have valid CDSCO registration certificates.
Is there a requirement for an Indian authorized agent if a foreign company is manufacturing the medical device?
Yes, a foreign company must have an Indian authorized agent or representative that will register with CDSCO and communicate with regulators for their compliance requirements.
What occurs when hospitals use unregistered Class C or D medical devices?
The use of unregistered devices is a violation of Indian regulations, can leave hospitals legally liable, expose their insurance policy coverage issues, and run the risk of prosecution under the Drugs and Cosmetics Act.
