India
India Regulatory Landscape
The Indian regulatory market is one of the fastest-growing markets in the medical device division. It is regulated by India’s Central Drug Standard Control Organization (CDSCO). As the national regulatory authority, CDSCO operates under the Ministry of Health and Family Welfare, Government of India. Its primary mission is to ensure that the medical devices, pharmaceuticals, and diagnostics available in India meet stringent safety, efficacy, and quality standards.
Historically, the regulation of medical devices in India was minimal until the early 2000s. In 1940, the Drugs and Cosmetics Act was established, initially focusing on pharmaceuticals. The act was amended several times over the decades to incorporate medical devices and address emerging challenges in healthcare. Significant progress was made in 2005 when the Medical Devices Rules were introduced, laying out the regulatory framework for the sector. Further advancements came with the Medical Device Rules of 2017, which provided a comprehensive regulatory regime specifically for medical devices, distinguishing them from pharmaceuticals. This pivotal change marked a significant step in aligning India’s regulatory landscape with international standards, promoting the growth of the medical device market while ensuring patient safety
Classification
India has adopted a risk-based classification system for medical devices, similar to that used in many other countries. This system is designed to ensure that devices are assessed and regulated according to their potential risk to patients and users. The classifications are differentiated according to the risk level, including Class A, B, C, and D. Class A represents low-risk devices, such as surgical dressings, while Class D includes high-risk devices, such as heart valves and implantable defibrillators. Their registration pathways are defined according to the risk level, with higher-risk devices undergoing a more stringent evaluation process. This structured approach ensures that medical devices are safe and effective before they reach the market, aligning with international best practices.
| Classification | Risk Level | Description | Registration Pathway | Registration and Renewal Fees |
|---|---|---|---|---|
|
Class A (Non-sterile and Non-Measuring) |
Low Risk |
Simple low-risk medical devices with minimal potential for harm to the user. They do not require sterilization or precise measurements and are subject to basic regulatory controls to ensure safety and performance. Examples include surgical dressings and thermometers. Due to their low risk, these devices undergo a streamlined registration process while still meeting essential safety and quality standards. |
Self-certify and registration with CDSCO |
Exempted |
|
Class A (Sterile and Measuring) |
Low Risk |
These devices are low-risk medical devices that either require sterilization or perform basic measurements. These devices are simple in design but necessitate additional regulatory controls to ensure they maintain sterility or measurement accuracy. Examples include sterile wound dressings and non-invasive blood pressure cuffs. While still considered low risk, these devices undergo slightly more rigorous evaluation to ensure safety and efficacy. |
Self-certify, registration, and QMS audit by CDSCO |
$1000 |
|
Class B |
Low Moderate Risk |
Class B devices are medium-risk medical devices that present a moderate potential for harm if used incorrectly. They are more complex than Class A devices and require more stringent regulatory oversight. Examples include hypodermic needles and surgical scalpels. These devices undergo a thorough review process to ensure they meet safety, quality, and performance standards before they can be marketed. |
Self-certify, registration, and QMS audit by CDSCO |
$2000 |
|
Class C |
Moderate High Risk |
Class C devices are high-risk medical devices that support or sustain human life, are implanted, or present a higher risk of injury if they fail. They require significant regulatory scrutiny and clinical evidence to demonstrate their safety and efficacy. Examples include orthopedic implants and diagnostic imaging equipment. The approval process for these devices is rigorous, involving detailed evaluation of their design, manufacturing, and clinical data. |
CDSCO review and approval, Clinical evaluation, QMS audit |
$3000 |
|
Class D |
High Risk |
Class D devices are the highest risk medical devices, often critical to sustaining life or preventing major health impacts. These devices are subject to the most stringent regulatory controls and must provide comprehensive evidence of their safety and effectiveness. Examples include implantable defibrillators and heart valves. The regulatory pathway for these devices involves extensive clinical trials and thorough assessment of all aspects of their performance and safety. |
CDSCO review and approval, Clinical evaluation, QMS audit, and post-market surveillance |
$3000 |
License Expiration and Renewal
The license is perpetually valid, and the retention fee is due after completion of every 5 years from its issue date. The authorized agent will deposit the fee to the Central Licensing Authority.
Authorized Agent / Local Representative
Yes, there is a requirement for an authorized agent to be your local representative and perform the due diligence. The Authorized agent must have a license to manufacture for sale or distribution or a wholesale license for sale or distribution (or have a registration certificate in Form MD-42) and should be given the Power of Attorney.
Reference Country / Home Country Approval
Applicants do not require Home Country Approval; however, having approval from reference countries such as the United States, Canada, the United Kingdom, the European Union, Australia, and Japan can expedite and enhance the approval process.
Product Registration
The product registration of medical devices in India is conducted through the Online System for Medical Devices (OSMD). This digital platform streamlines the registration process, enabling manufacturers to submit applications, track their status, and comply with regulatory requirements efficiently. The system ensures transparency and facilitates timely communication between the regulatory authority and applicants, thereby expediting the approval process while maintaining rigorous standards of safety and quality for medical devices.
Class A (Non-Sterile and Non-Measuring) Medical Devices:
- Register with the Online System for Medical Devices Portal for an Import License in Form MD-14.
- Upload information for product registration, which mainly includes manufacturing site address information and device details, and undertaking from the manufacturer that the device qualifies as a Class A non-sterile and non-measuring device.
- Self-attested copy of the overseas manufacturing site-related information or get a Free Sales Certificate issued by the national regulatory authority.
- The manufacturer has to self-certify by stating that the product conforms to the essential principles of safety and performance and sign that the information is true and authentic.
Class A (other than sterile and measuring medical devices) and Class B:
- Register with the Online System for Medical Devices Portal for an Import License in Form MD-14.
- Uploading information for product registration which mainly includes manufacturing site address information and device details, and undertaking from the manufacturer that the device qualifies as a Class A sterile and measuring device or Class B device.
- Self-attested copy of the overseas manufacturing site-related information or get a Free sales certificate issued by the national regulatory authority.
- A medical device imported from countries other than those stated above will be required to establish its performance and safety through published safety and performance data or a clinical investigation in the country of origin along with a Free Sales Certificate from the same country.
Class C and Class D:
- Register with the Online System for Medical Devices Portal for an Import License in Form MD-14.
- Upload information for product registration, which mainly includes manufacturing site address information and device details, and undertaking from the manufacturer that the device qualifies as a Class C device or Class D device.
- Self-attested copy of the overseas manufacturing site-related information or get a Free sales certificate issued by the national regulatory authority.
- A medical device imported from countries other than the one stated above will be required to establish its effectiveness and safety through a clinical investigation in India.
- If the medical device does not have a predicate in India, one must file Form MD-27.
- If the medical device is a new In-Vitro Diagnostic (IVD) with no predicate in India, one must additionally file Form MD-29.
Clinical Investigations
In order to conduct clinical investigations of the device the applicant has to be made to the Central Licensing Authority in Form MD-16 and pay the fee according to the second schedule. The applicant is granted in the name of test license, and they can initiate their investigations.
Post-Market Surveillance
The responsibility for PMS comes under the licensed holder/authorized agent. As mentioned in the QMS requirements posted by the CDSCO for PMS data reporting the data should include the complaints received and the corrective and preventive actions (CAPA) taken for the same. This should be presented in the manner of Periodic Safety Update Reports (PSUR). These PSURs shall be submitted every six months after getting market approval for the first 2 years and later it should be done annually for the next 2 years. The Indian government has established a platform under the name of the Materiovigilance Programme of India (MvPI) this portal can be used by manufacturers to report serious adverse events related to the devices.
Special Cases:
- If the Central Licensing Authority has a reason to believe that the quality of the medical device is compromised, and decides to subject it to evaluation, test, or examination, the authorized agent shall pay a fee for such evaluation, test, or examination, to the testing laboratory as specified by the Central Licensing Authority.
- On receipt of an application, the Central Licensing Authority may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose. The applicant shall be liable to pay a fee as specified under the Second Schedule regarding expenditure required in connection with the visit to the overseas manufacturing site.
Fees and Timelines
- The actual timeline for the grant of a license can range from a few weeks to several months, depending on the specific details of the application, the responsiveness of the applicant in providing additional information if requested, and any potential regulatory reviews or inspections that may be required.
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