Navigating the Regulatory Landscape: Medical Device in India

In India, the term "medical device" (MD) refers to instruments, apparatus, appliances, implants, materials, or other articles used for:

Diagnosis, prevention, and treatment of diseases or disorders
Monitoring physiological conditions
Supporting or assisting in medical therapy

These devices can be used internally or externally on humans.

Medical devices are regulated under the Drugs and Cosmetics Act, 1940 and its corresponding rules. The Central Drugs Standard Control Organization (CDSCO) is responsible for approving new medical devices. Only certain categories of medical devices, called "notified devices", require approval from CDSCO.

Lest go throught the steps involved on meeting regulatory compliance for medical devices in India

{tocify} $title={Table of Contents}

Scope of Medical Device

The first step is to establish the scope of the medical device, or simply put, the purpose of the device. Does it diagnose, prevent, treat, monitor, support, or assist in medical therapy? Be specific about the intended use of your device. Is it a diagnostic tool, an implant, a monitoring device, or something else? Knowing the function helps categorize your device and determine the regulations that apply. Scope will determine the risk level involved with the device.

India classifies medical devices into four categories (A-D) based on their potential risk to patients.

Class A (Low Risk) - Requires minimal regulation and/or registration process (sterile / measuring)
Class B (Moderate Risk) - Requires a registration process.
Class C (High Risk) - Requires a more stringent approval process.
Class D (Highest Risk) - Requires the most rigorous approval process.

The intended use / scope of the device can be adjusted to get quick approvals and early market entry. For example, if the scope is limited to measurement instead of diagnosis, the less stringent regulatory requirements will be applicable and the product can be placed in the market with the limited functionality and scope. This can be useful for early feedback or prevent long entry to market time for a sophisticated. The features / scope of the device can be further increased, and necessary regulatory approvals can be done subsequently.

Product (MD) Design Finalization

This phase starts by establishing the product requirements. During this phase, we discuss what the device will be used for and what materials it needs. For example, how long it should last, what materials it should be made of, and what surfaces it should stick to. To figure out the materials needed, we look at different options for adhesives and backing materials. In certain cases, a confidential agreement or a quality agreement are done with the vendors to make sure everyone understands what needs to be done and to protect everyone involved.

Prototyping

Medical device prototyping is an early development stage where a model or sample is created to demonstrate the basic appearance, operation, and outcomes of a product. The process typically involves several stages:

Product Concept: Initial ideas and concepts are explored. Physical mockups or concept models are used to pitch the idea to stakeholders.
Proof of Concept (PoC): A functional prototype is created using basic materials to test the design's usability and feasibility of the idea.
Alpha Prototype: This is a non-functioning sample used to test dimensions, tactile feel, and appearance. Alpha prototypes are often produced using 3D printing technology.
Beta Prototype: Iterative improvements are made based on feedback. This prototype is closer to the final product and undergoes more rigorous testing.

Not every component is suitable for all applications, and it's crucial to consider that certain combinations may be incompatible. It's essential to conduct thorough testing on various combinations of materials to identify the optimal choice for your device.

Suitable bench tests like EMC (Electromagnetic compatibility), EMI (electromagnetic interference), drop, cycling, wash, may be performed, to evaluate the suitability of selected design and component. In case any testing needs to be done on a human subject for exploration / validation, then a prior approval is required for ethics committee.

Documentation is the most essential aspect during the development and regulatory lifecycle of the product. The scope of the product is something which will definitely be defined in a documentary form, but it is equally important to document the product design phases. This can be done in any format as suitable and traceable, but eventually these documentations will translate into a Design History File (DHF).

A Design History File (DHF) is like a scrapbook that tracks the development journey of a medical device. It's a collection of documents showing exactly how the device went from idea to finished product. The content of DHF includes:

Initial ideas and plans: This includes things like what problem the device solves and its intended use.
Design decisions: Documents explaining why certain materials, features, or functions were chosen.
Testing results: Proof that the device meets safety and performance standards.
Changes made along the way: Records of any modifications made during development.

Basically, the DHF shows a clear trail of how the design evolved, ensuring it meets requirements for patient safety.

Test Licensing

A new medical device may need to be rested before full-scale commercialization. A test license is required for performing below activity:

Clinical Investigations: Testing the device on human subjects to see if it's safe and effective.
Evaluation and Demonstration: Assessing the device's performance and showcasing it to potential users.
Training: Providing healthcare professionals with hands-on experience with the device.

This is crucial to prevent unauthorized import or manufacturing of medical devices in India without proper licensing, ensuring controlled testing before a full market launch, and verifying that the device meets safety and performance standards before it reaches patients.

Important information needed to apply for test license include:

Device Information: Details like the device name, model, intended use, and classification (Class A, B, C, or D).
Technical Specifications: Documents explaining the device's design, materials, and functionalities.
Testing Plan: A clear outline of how you'll be testing the device, including the purpose, methodology, and expected outcomes.
Import/Manufacturing Details: Information about the manufacturer/supplier and the quantity of devices needed. Manufacturing plant layout, people involved, equipments used etc.

Further, you'll may be required to manufacture at least three batches of the device for testing purposes. This allows for quality control checks, including how the device performs over time and whether your manufacturing process consistently produces high-quality devices.

If the device developed is to be used on human subject for the purpose of Clinical investigation, then the facility should be Quality Management System compliant.

In India, an investigational medical device is a device that doesn't have a similar or predicate device already available in the country. These devices are subject to clinical investigations on human participants in India to demonstrate their safety, performance, and effectiveness.{alertInfo}

Clinical Investigation (CI)

In India, before a new medical device can be marketed and used on patients, it needs to go through a series of tests and evaluations. This process, called a Clinical Investigation (CI), helps ensure the device is safe and effective for its intended purpose. The Central Drugs Standard Control Organization (CDSCO) regulates CIs for medical devices.

A CI is generally mandatory for most investigational medical devices (except for some Class A devices) before they can be used in human trials. This includes devices still under development, prototypes, or those planned for significant modifications.

Important information needed to get approval from CDSCO for conducting an CI include:

Device Information: Details like device name, model, intended use, classification, and risk profile.
Clinical Investigation Plan (CIP): A comprehensive document outlining the study design, objectives, methodology, participant selection criteria, risk management plan, and data collection procedures for Pilot* / Pivotal* studies.
Investigational Brochure (IB): Information for investigators and participants about the device, its intended use, potential risks and benefits, and study procedures.
Investigator Qualifications: Documentation demonstrating the experience and expertise of the investigators who will conduct the study.
Ethics Committee Approval: Evidence of ethical approval for the study from an authorized Ethics Committee.

Pilot and Pivotal studies are both used in medical device development, but with different goals. A pilot study is a smaller, exploratory trial that tests the feasibility of a larger study and gathers preliminary data. Think of it as a test run. In contrast, a pivotal study is the main event, a larger and more rigorous trial designed to definitively prove the safety and effectiveness of the device for regulatory approval. It's like the final exam after all the preparation.{alertInfo}

Once the CI is completed, you'll need to thoroughly analyze the collected data. This involves assessing the device's safety, efficacy, and any potential risks and benefits. Based on the analysis, a comprehensive CI report needs to be prepared. This report will detail the study design, methodology, results, conclusions, and any adverse events encountered during the investigation. The final CI report, along with any relevant updates or amendments, needs to be submitted to the CDSCO for review and evaluation.

It is important to note that test data for the bench test performe for the device also needs to be compiled along with the CI data.

Manufacturing License

As already metioned you need a import / manufactruing license from CDSCO to import or manufacture a medical device in India. Assuming positive CI results, you can then proceed with applying for a manufacturing license. This process involves ensuring your manufacturing facility meets all CDSCO's Good Manufacturing Practices (GMP) guidelines. Important apects include ISO 13485 certification, SOP's, Work Instruction, People training, Quality control etc.

In case the medical device consist of two or more conponents, then the final assembly factory with an ISO 13485 certification is required.

An application needs to be submitted through the CDSCO online portal, including details about your manufacturing facility, quality control procedures, and the device specifications. The CDSCO might conduct an inspection of your manufacturing facility to verify compliance with GMP regulations. If everything is satisfactory, the CDSCO will grant you a manufacturing license for your medical device.

Predicate Device Route

The predicate device route is a strategy you can explore to potentially avoid a full Clinical Investigation (CI) for your medical device when seeking approval from the CDSCO in India. Here's how it works:

The idea is to identify an existing medical device, called the "predicate device", that is already approved for marketing in India and is similar to your device in terms of:

Intended Use: Both devices should address the same medical condition or have the same purpose.
Technological Characteristics: The design, materials, and functioning principles of your device should be closely comparable to the predicate device.
Risk Profile*: The potential risks associated with both devices should be similar.

Identify a suitable predicate device by researching existing medical devices in the market and consulting regulatory databases. This will involve literatue research, accessing CTRI (Clinical Trials Registry- India) Data, Adverse events, Recalls etc. You'll need to prepare a comprehensive document demonstrating the equivalence of your device to the predicate device. This document should address the similarities in intended use, technological characteristics, and risk profile. It shoud also adress how the adverse effects and recalls of predicate device are not applicable or take care by you device. The CDSCO will review your equivalence demonstration and determine if it justifies waiving the requirement for a full CI.

The Risk Profile of a medical device is how likely it is to cause harm. It's important to consider this to ensure patient safety. Complex devices used by patients at home have a higher risk profile than simple devices used by professionals. So for example Pacemakers, despite their benefits, have some risks. These include infection from the implant site, malfunctioning of the device itself, interference from external factors like magnets, and rarely, an infection of the heart lining.{alertInfo}

Referense Resourse:

Regulatory pathway to be followed for the Medical Device from its development to commercialisation under Medical Devices Rules, 2017

{getButton} $text={Download} $icon={download} $color={#2a7373}