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Understanding Medical Device Regulations In India: A Guide To Regulatory Compliance

The regulation of medical devices is a crucial aspect of public health policy, ensuring that innovative healthcare solutions are safe and effective for patient use. In India, the landscape of medical device regulation has undergone significant changes over the last few decades, particularly with the introduction of the Medical Device Rules in 2017. This paper delves into the complexities of India's regulatory environment by critically analyzing the current regulatory framework around medical devices in India and identifying gaps.

The study explores what constitutes medical devices, their significance in healthcare, different classifications of medical devices, and provides an overview of the global medical devices market, focusing on India. Before discussing Indian regulations on medical devices, the study also examines regulations in prominent countries such as the USA, the European Union, Japan, and China. Furthermore, it delves into the history and evolution of legislation related to the regulation of medical devices in India, assesses current regulations, and their impact on industry trends.

As India solidifies its position as a significant player in the global medical device industry, the need for a robust, transparent, and adaptable regulatory framework becomes increasingly critical. This study offers a comprehensive overview of the current landscape and a forward-looking perspective on the future of medical device regulation in India.

What are Medical Devices?

Medical devices have been used for treating and diagnosing diseases since ancient times. For example, there is evidence that people performed trephination in the Neolithic period, and tools from around 2000 BC have been found in Jericho.[1]. With the advancement in technology and increasing quality of healthcare services, medical devices have become an indispensable part of the healthcare industry. According to the World Health Organisation, "a medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination for a medical purpose"[2].

Simply put, medical devices can be understood as tools or equipment used for diagnosing, treating, or preventing health conditions. They can range from simple items like bandages or thermometers to complex machines like pacemakers or MRI scanners. Unlike drugs, they don't rely on pharmacological, immunological, or metabolic means to work on the body, but they assist in healthcare through physical or mechanical means.

Classifications of Medical Devices

The international classification system of medical devices varies across regions. For example, in the European Union, medical devices are classified into four classes on the basis of their potential risks[3]. In the United States, the Food and Drug Administration classifies medical devices based on their risks and the regulatory controls necessary into three classes to ensure they] are safe and effective[4].

In India the regulations of medical devices are governed by the Medical Devices Rules, which were published by the Central Government in 2017. Under these rules, the term 'class,' although widely used to prescribe different rules and procedures for different classes of medical devices, but up until 2020, there was no clarity regarding which device falls into which particular class.

To overcome this ambiguity, the Medical Device Division of Central Drugs Standard Control Organization of India (CDSCO) issued a notice in 2020 properly classifying the medical devices into different categories and four classes which are A, B, C, and D[5]. Class A devices are deemed to have the lowest risk, whereas Class D devices are considered to have the highest risk. To determine which class a medical device belongs to, there are specific rules prescribed in the Medical Devices Rules, 2017, which contain a list of parameters that vary on the type of device (in-vitro or other medical devices) and take into account the device's intended use.

These classes are utilized to get a manufacturing license for medical devices in India. In this regard, CDSCO has also created a list of more than eighteen hundred medical devices and distributed them into 24 categories. Then, further, on a risk-based approach, these devices are assigned a class out of the four defined classes

Medical Devices Market

The global market of medical devices has reached an all-time high with an estimated market size of USD 637.04 billion in 2024 and is expected to reach USD 893.07 billion by 2029.[6] According to the Mordor Intelligence report Medical Devices Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)[7], the prominent factors responsible for this boost are the increasing prevalence of chronic disease, technological advancements in medical devices, and a consistent rise in the aging populations. India is among the top twenty global markets for medical devices and ranks as the fourth largest market in Asia, following Japan, China, and South Korea, with the medical device industry accounting for over 65% of the total market.

However, the majority of the market is predominantly import-driven[8], whereby 70-80% of imports are done from countries such as the US, China, and Germany[9]. These statistics highlight the significant gap between the current demand and supply of medical devices in India. Some of the top medical device companies by revenue in India as of toady include Johnson & Johnson Private Limited, Abbott India Limited, Siemens Healthcare Private Limited, and so on[10]. In the Budget 2024-25, Rs. 90,659 crore was allocated as the budget for the healthcare and pharmaceutical sector, which is a 13% rise over the revised estimate of 2023-24. We, therefore, can hope for new developments and expansions of industry[11].

Regulations Of Medical Devices

According to the World Health Organisation, the main purpose behind the regulations of Medical Devices is to enable patients access to high-quality, safe, and effective medical devices with the broader aim of public health and the safety of patients, healthcare workers, and the community.[12] In the 60th World Health Assembly held in Geneva in May 2007, a Resolution was adopted termed World Health Assembly(WHA) Resolution 60.29[13] to encourage member states to develop national or regional guidelines for effective manufacturing and regulatory practices related to medical devices.

The Global Framework of Regulation of Medical Devices
Before exploring the regulatory framework for medical devices in India, it is essential to provide a brief overview of the frameworks used globally.

European Regulations:
- The regulation of medical devices in the EU is governed by a series of directives and regulations, with a primary goal of ensuring public health and safety. The key directives include:
  - 90/35 directive on active implants
  - 93/42 general medical device directive
  - 98/79 directive on in vitro diagnostics
  - 20000/70 directive covering human blood and plasma derivatives
- In the EU, a directive is basically an instruction to its member states to implement a law through national regulations.
- These directives set out essential requirements for manufacturers, including the conformity assessment process, which is overseen by "notified bodies" - independent entities designated by each EU member state's competent authority.
- Each EU member state has a competent authority responsible for:
  - Regulating medical devices
  - Designating notified bodies
  - Overseeing clinical trials
  - Ensuring compliance with the Medical Devices Act
- The notified bodies are responsible for:
  - Evaluating devices according to the manufacturer's claims
  - Ensuring compliance with EU standards
- These bodies are monitored by the competent authority of the member state and the Notified Body Operations Group (NBOG). Once a device is approved by a notified body, it can carry the CE mark and be sold throughout the EU and in other countries with mutual agreements.
United States Regulations:
- In the United States, the Federal Food, Drug, and Cosmetic Act regulates medical devices.
- A marketing application must be submitted to the Food and Drug Administration (FDA), and approval must be obtained before a medical device can be marketed in the country.
- Within the FDA, the Center for Devices and Radiological Health (CDRH) is mainly responsible for overseeing both the premarket and postmarket regulation of medical devices.
- The United States uses a risk-based classification system for medical devices, categorizing them according to the level of risk they pose:
  - Class I (lowest risk)
  - Class II (intermediate risk)
  - Class III (highest risk)
Japan:
- Japan has been reforming its pharmaceutical and medical device legislation to align more closely with the Global Harmonization Task Force (GHTF) classification system.
- While the classification of medical device products under Japan's Pharmaceutical Affairs Law generally corresponds with the GHTF system, Japan, like Europe, has adopted third-party certification for Class II devices.
- The Ministry of Health, Labour, and Welfare (MHLW) in Japan initially reviews the dossier to determine if the device is suitable for third-party assessment. If deemed appropriate, one of the 12 designated certification bodies conducts the evaluation.
- Once the third-party assessor issues a positive report, the Ministry of Health, Labour, and Welfare (MHLW) provides a certificate.
- The assessors use the GHTF's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) during the product application process.
- By the end of 2011, it is expected that all Class II devices in Japan will be regulated through third-party certification.
China:
- In China, medical devices are regulated by both the central State Food and Drug Administration (SFDA) and local provincial authorities.
- The regulatory system is risk-based, akin to that in India.
- Class II and Class III devices must undergo sample testing (type testing) in approved laboratories.
- Additionally, some products are required to undergo clinical evaluations in SFDA-approved hospitals.

The SFDA runs its own evaluation center and has set up expert technical committees to aid in the regulatory process. Chinese regulations require foreign companies to collaborate with a local distributor based in China. Provincial authorities handle inspections, and for devices manufactured abroad, proof of approval from the country of origin is required. For example, a U.S.-based company cannot introduce a new device into the Chinese market unless it is already registered with the U.S. FDA.

Regulations of Medical Devices in India
In India, the Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority overseeing the sale, import, and manufacture of medical devices that are categorized as drugs under Section 3(b)(iv) of the Drugs and Cosmetics Act. The CDSCO sets standards for drugs, cosmetics, diagnostics, and medical devices and issues licenses to manufacturers and importers. It is also responsible for enforcing regulatory measures, suggesting amendments to relevant Acts and Rules, overseeing the market authorization of new drugs, regulating clinical research in India, and ensuring standards for imported drugs.[19] Before examining the current regulations governing medical devices in India, it is essential to explore the evolution and history of the legislative framework that has shaped the regulation of medical devices in the country.

History and Evolution of Legislative Framework
The Drugs and Cosmetics Act was enacted in 1940[20] in India in order to regulate the manufacture, import, distribution, and sale of drugs and cosmetics in India. However, the act did not specifically deal with medical devices up until notification in 1982. Between 1982 and 2020, several legislative developments occurred to enhance the regulatory framework for medical devices in India. A brief overview of these key events is outlined below:

13 November 1982- The definition of "drugs" under the Drugs and Cosmetics Act of 1940 was amended to include medical devices that the Government may notify from time to time. Once notified, these devices are regulated under the framework of the Act.[21] Even today, for a device to be recognized as a medical device, it must first be notified as a "drug" under the DCA. Only after this notification is it subject to the regulatory frameworks established by the DCA.

17 March 1989- The Health Ministry notified the following devices: disposable hypodermic syringes, disposable hypodermic needles, and disposable perfusion sets.[22]

22 February 1994- Rules specifying the requirements for factory premises involved in the manufacture of medical devices were notified. [23]

20 January 2005- The Health Ministry issued guidelines and requirements for obtaining approval to import or manufacture new drugs and for conducting clinical trials. Although medical devices are technically included under these rules as they are categorized as "drugs," the rules were primarily designed with drugs in mind, rather than medical devices. In fact, medical devices are mentioned only once in the entire text of these rules.[24]

In between 2005-2006, some more medical devices were included under the ambit of notified devices.

2006- The Ministry of Science and Technology released a draft of the "Medical Devices Regulation Bill, 2006" for public feedback. [25] This Bill proposed the creation of a Medical Device Regulatory Authority of India and introduced a risk-based classification system for medical devices. It recognized the limitations of classifying medical devices as 'drugs' under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, noting that the existing definition did not cover all types of devices.

31 October 2012- The Central Drugs Standard Control Organisation (CDSCO) issued a guidance document for the import of medical devices, specifying 21 products that are included under this regulation.

1 January, 2017- The Health Ministry brought the Medical Device Rules, 2017 (MDR, 2017)[26], bringing many significant changes, which includes the following:

A single window system for registration, review, and submissions through the online portal 'SUGAM';
Manufacturing and import licenses will remain valid indefinitely unless voluntarily surrendered. [27];
Introduction of a risk-based classification system with four classes of devices (Class A, Class B, Class C, and Class D) in ascending order of risk, with regulatory requirements and licensing authorities based on the device's risk class.
The roles of regulators under these rules are generally time-bound.
Compliance and oversight for clinical trials related to medical devices have been separated from Schedule Y of the Drugs and Cosmetics Rules, 1945, and are now included in the Seventh Schedule of MDR, 2017, which specifies the format for each submitted document.
A "Unique Device Identification" system for each medical device is scheduled to be introduced in January 2022. [28];
7 November 2017: The DCGI released a list of 247 devices, classified according to their risk levels and detailing their intended uses. [29].
18 October 2019: The Health Ministry released a draft notification proposing a registration mechanism for certain medical devices, whether locally manufactured or imported. It specified 36 devices that would require registration with CDSCO through the online portal. [30]
3 December 2018: The Health Ministry notified the following devices: [31] Digital Thermometer, Nebulizer, Blood Pressure Monitoring Devices, and Glucometer.
18 December 2019: The Niti Aayog held a stakeholder meeting to discuss its draft Medical Devices (Safety, Effectiveness, and Innovation) Bill, 2019. The meeting proposed establishing the Medical Devices Administration, which would operate alongside the CDSCO, under the Directorate General of Health Services (DGHS). [32] One reason cited by Niti Aayog was that the CDSCO and DCGI may lack the specialized expertise needed to effectively oversee medical devices. [33]
11 February 2020: The Health Ministry broadened the definition of "drugs" in Section 3(b) to encompass all devices intended for: diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder; diagnosis, monitoring, treatment, alleviation, or assistance for any injury or disability; investigation, replacement, modification, or support of anatomical or physiological processes; supporting or sustaining life; disinfection of medical devices; and control of conception. [34] The expanded definition also includes software and accessories, potentially classifying all wearables with health features as medical devices.

Current Regulatory Framework for Medical Devices in India
India's medical devices are regulated by two key bodies: the Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research. The regulatory framework is primarily governed by the Medical Device Rules, 2017, and the Drugs and Cosmetics Act, 1940.

The CDSCO, operating under the Ministry of Health and Family Welfare, regulates medical devices and IVDs through the Drug Controller General of India (DCGI). The Medical Device Rules, 2017, introduced a risk-based classification system, streamlined the licensing processes, and differentiated medical device regulations from the broader drug regulations under the DCA. In April 2020, these rules were amended to extend regulatory control to all medical devices, expanding beyond the 37 categories that were previously regulated.

Scope of Regulation and Definition of Medical Devices

As of April 1, 2020, all medical devices are regulated under the Drugs and Cosmetics Act, 1940 (DCA) and the Medical Device Rules, 2017 (MDR). According to MDR Amendment 2020, medical devices that meet the following definition will be regulated as drugs under the "DCA and MDR [35]": "All devices, including an instrument, apparatus, appliance, implant, material, or other article, whether used alone or in combination, including software or an accessory, intended by their manufacturer to be used specially for human beings or animals, which does not achieve the primary intended action in or on the human body or animals by any pharmacological, immunological, or metabolic means, but which may assist in its intended function by such means for one or more of the aforementioned:

Diagnosis, prevention, monitoring, treatment, alleviation, or assistance for any disease or disorder;
Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
Investigation, replacement or modification or support of the anatomy or of a physiological process;
Supporting or sustaining life;
Disinfection of medical devices; and
Control of conception.

Risk-based Classification

The Medical Devices Rules, 2017, implemented by the Central Drugs Standard Control Organization (CDSCO), introduced a risk-based classification system for medical devices, in line with the guidelines established by the Global Harmonization Task Force (GHTF).[36] This system classifies medical devices into four categories based on their risk levels:

Class A (low risk)
Class B (low to moderate risk)
Class C (moderate to high risk)
Class D (high risk)

The extent of regulatory scrutiny and the specific requirements vary according to the device's risk classification.

The classification method is thoroughly outlined in the first schedule of the 2017 Rules. However, it is pertinent to note that, unlike some other countries where manufacturers or importers have the flexibility to self-classify their products for registration purposes, the 2017 Rules do not allow this. Instead, manufacturers and importers must adhere to the classification determined by the Drug Controller General of India (DCGI).[37] The classification once done, will unfortunately be non-appealable[38]

Registration Process

Registration Documentation Requirements:

Device Master File (DMF)
Plant Master File (PMF)
Clinical Evaluation Report
Risk Management Report
Performance Evaluation Report (if applicable)
Quality Management System (QMS) Accreditation: Compliance with ISO 13485 or equivalent is mandatory.
Bureau of Indian Standards (BIS) Certification: Certain devices must meet Indian Standards.
Labeling: Must comply with Medical Devices Rules 2017, including manufacturer details, batch number, and expiry date.

Application Submission:

Submit an application in Form MD-14 (for Class A/B) or Form MD-15 (for Class C/D) via the online Sugam portal.
Include required documents such as DMF, PMF, clinical data, and QMS certification.

Review and Scrutiny:

CDSCO reviews the documents for completeness and regulatory compliance.
For Class C and D devices, a detailed technical review is conducted, possibly involving expert consultations and the Technical Advisory Committee (TAC).

Inspection and Verification:

CDSCO may inspect manufacturing facilities for compliance with QMS and Good Manufacturing Practices (GMP).
For imported devices, inspections may be conducted or reports from recognized authorities may be reviewed.

Approval and Licensing:

Upon successful review and inspection, CDSCO issues a registration certificate and import/manufacturing license (Form MD-5 for Class A/B, Form MD-6 for Class C/D).
The license is valid for five years, requiring renewal thereafter.

Timeline:

Class A and B Devices: Typically 3-6 months, with a possible extension of 1-2 months for inspections.
Class C and D Devices: Usually 6-12 months, with possible extension of 2-3 months for detailed scrutiny and inspections.

Preparation:

Thorough preparation and adherence to CDSCO's documentation, QMS, and labeling requirements are essential for successful registration. Understanding the timelines aids in strategic planning for market entry into India's expanding medical device sector.

Manufacturing of Medical Devices for Sale or Distribution
Rule 20 of Chapter III of Medical Devices Rules, 2017 talks about the manufacture of Class A or Class B medical devices for sale or distribution, and Rule 21 for Class C or Class D medical devices. Under Rule 20, an application for grant of license or loan license to manufacture for sale or for distribution to the State Licensing Authority, whereas under Rule 21, application shall be made to the Central Licensing Authority through an identified online portal of the Central Government. There are different steps to obtaining a manufacturing license depending upon the Class of medical devices, the licensee wants to acquire license of. These steps and procedures are easily available online on the CDSSCO official website[39].

Compliance and Certification
ISO 13485 Compliance- Quality Management System (QMS): Manufacturers are required to establish, document, and maintain a QMS as per ISO 13485 standards, ensuring ongoing compliance through regular audits.

Gaps in Medical Devices Rules, 2017

Definition and Classification: The rules do not comprehensively define all categories of medical devices. For example, certain devices that are emerging due to technological advancements, such as software-driven or AI-based devices, may not have specific classifications or definitions. This lack of specificity can lead to inconsistent regulatory oversight and may result in some devices being either over-regulated or under-regulated.
Regulatory Oversight: There is ambiguity regarding the roles and responsibilities of various regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO) and state-level bodies. This overlap can lead to inconsistent enforcement of rules and potentially conflicting guidance, creating confusion for manufacturers and importers about compliance requirements. Clear delineation of authority is essential for a streamlined regulatory process.
Quality Standards: While the rules provide a framework for quality management systems, they do not specify detailed quality standards for all types of medical devices, especially innovative and high-risk devices like implantable medical devices. The absence of specific quality benchmarks can make it challenging for manufacturers to ensure their products meet safety and efficacy requirements consistently. This gap also impacts the ability of regulators to uniformly assess device quality.
Market Surveillance: The rules lack a robust mechanism for post-market surveillance, which is crucial for monitoring the safety and performance of medical devices once they are in use. Effective post-market surveillance would include a system for reporting adverse events, regular inspections, and a process for corrective actions. Without these mechanisms, potential safety issues may go undetected, posing risks to patient health.
Harmonization with Global Standards: The Medical Devices Rules 2017 are not fully harmonized with international standards such as those set by the International Medical Device Regulators Forum (IMDRF) or the European Union's Medical Device Regulation (MDR). This lack of alignment can hinder international trade and affect the competitiveness of Indian manufacturers in global markets. Moreover, it may create challenges in ensuring the quality of imported medical devices that are regulated differently in their country of origin.
Innovation and Research: The current rules do not adequately encourage innovation or provide incentives for research and development in the medical device sector. There is a need for a more supportive regulatory framework that facilitates the introduction of innovative products, including faster approval processes for novel devices and funding support for research. Encouraging innovation is essential for keeping pace with technological advancements and meeting emerging healthcare needs.

Conclusion and Recommendations:
While the Medical Devices Rules 2017 have notable gaps, it is important to recognize that these rules represent a significant breakthrough in India's regulatory landscape. Prior to their implementation, there were no specific rules or legislation exclusively governing medical devices in India. The introduction of these rules marked the first attempt by the Indian government to provide a structured regulatory framework for medical devices, which is a commendable step towards ensuring the safety and efficacy of these products.

Moreover, the government has demonstrated a commitment to improving this regulatory framework. For example, the Ministry of Health and Family Welfare released the draft of the New Drugs, Medical Devices, and Cosmetics Bill, 2022 ("Draft Bill") for public comment in July 2022. This Draft Bill is intended to be a comprehensive piece of legislation that includes provisions to regulate not just medical devices, but also drugs, cosmetics, clinical trials, and online pharmacies, among other aspects. Once enacted, the Draft Bill will replace the outdated Drugs and Cosmetics Act, 1940, which is currently India's primary regulation for drugs.

The release of the Draft Bill indicates that the government is aware of the existing gaps and is actively working towards addressing them. We can expect that the provisions in the new legislation will fill the current gaps and provide a more robust and comprehensive regulatory environment for medical devices in India. This evolving regulatory framework is a positive sign that India is moving towards better regulation, which will enhance patient safety and promote innovation in the medical device industry.

To further enhance the regulatory framework and address existing challenges, targeted measures must be adopted. These measures will not only ensure compliance with global standards but also promote a more efficient and innovative medical device industry in India.

Strengthening Regulatory Frameworks: Continuous updating and refinement of the Medical Device Rules, 2017, are essential to keep pace with global standards and technological advancements. This should include greater clarity on classification and registration requirements to streamline compliance processes for manufacturers.
Enhancing Collaboration and Training: Establishing more robust collaboration between regulatory bodies, industry stakeholders, and healthcare providers will improve compliance and foster innovation. Additionally, regular training programs should be implemented to educate manufacturers on regulatory requirements and quality management standards.
Facilitating Market Access for SMEs: Special incentives and support mechanisms should be developed to help small and medium-sized enterprises (SMEs) navigate the complex regulatory environment. This could involve subsidies for compliance costs, simplified registration processes, or technical support from regulatory bodies.
Leveraging Technology for Compliance: The adoption of digital tools and platforms, such as the SUGAM online portal, should be expanded to improve transparency and efficiency in the regulatory processes. Utilizing advanced data analytics and AI can also enhance the monitoring and evaluation of medical devices in the market.
Promoting Local Manufacturing: To reduce dependency on imports, policies should encourage local manufacturing of medical devices. This could involve tax incentives, relaxed regulations for domestically produced devices, and investment in research and development to build capacity within the country.

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