MEDICAL DEVICE REGULATION IN INDIA

Introduction - By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device markets worldwide is the Indian market. By 2025, its current valuation of $5.2 billion is anticipated to rise to $50 billion. In India, the Drugs and Cosmetics Act of 1940 governed devices; there were no particular regulations about medical devices. The Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India, were released by the Central Drug Standard Control Organization to close this gap. These regulations address a number of device-related topics, such as post market requirements, labeling, sales, manufacturing and import, registration, and classification. The regulations are a step in the right direction and cover most of the European Union (EU) approval procedures, which require that the devices work as intended and are safe. However, given how quickly medical device technology is developing, it is important to clarify and update the current regulatory framework to harmonize standards and bring them into compliance with more progressive laws like EU-MDR, USFDA, etc.

What is CDSCO - The Central Drugs Standard Control Organisation (CDSCO) falls under the jurisdiction of the Indian government's Ministry of Health & Family Welfare's Directorate General of Health Services. The Drugs & Cosmetics Act of 1940 established regulations for both drugs and cosmetics, and it also approved new drugs and carried out clinical trials. The objectives of CDSCO are to maintain consistency in the services it offers, as well as to be open and accountable. The duty of granting licenses for medical devices—falls on state regulators.

What is IMDR - The Central Drug Standard Control Organisation's (CDSCO) Medical Devices and Diagnostics Division created the Medical Device Regulations (IMDR), published in January 2017 and enacted in January 2018. To amend the IMDR, the "Medical Devices (Amendment) Rules, 2020" were drafted in February 2020 and went into effect in April of the same year. With the release of the 2020 amendment, "registration of certain medical devices" was added.

The IMDR states that the following guidelines apply to medical devices:

·? Licensing is available for import, manufacturing for distribution or sale, stock, display, or offer for sale.

·? It may be produced for testing, evaluation, examination, clinical research, demonstration, or training.

What is a medical device as per IMDR- "Medical device" refers to:

(A) materials used for in vitro diagnostic procedures;

(B) materials, including mechanical contraceptives (condoms, intrauterine devices, tubal rings);

(C) materials periodically notified under subclause (iv) of clause (b) of section 3 of the Act;

(D) materials used for surgical dressings, bandages, staples, sutures, ligatures, and blood and blood component collection bags with or without anticoagulant covered under subclause (i);

Medical device classification - Medical device risk is classified into four categories by the Central Licencing Authority (CLA) of India based on the device's intended use, associated risks, and other factors mentioned in the IMDR.

1.?? Low risk-Class A

2.?? Low, moderate risk-Class B

3.?? Moderate high risk-Class C

4.?? High risk-Class D.

The following guidelines form the basis of how medical devices are categorized:

·? The device's intended use will determine the application of classification.

·? Combination items or add-ons should be categorized individually

·? Software should be classified under the same heading as its connected device.

·? Multiple-purpose devices should be categorized according to their most important use.

·? Stricter rules that lead to a higher classification should be applied if multiple rules apply.

Manufacturing - The State Licencing Authority issues or loans a license based on an application to manufacture class A & B devices. However, CLA grants the license or loan license to manufacture class C & D devices. If the license retention fee is paid five years from the date of issuance, the licenses are everlasting unless suspended or revoked. Medical devices in small quantities can be produced for clinical research, testing, assessment, inspection, demonstration, or training. The period of validity of this license is three years.

Clinical investigation - All class B, C, and D medical devices made in India that are investigational, without a predicate device, and produced there must undergo clinical investigation. However, suppose the device has been on the market for at least two years in Australia, Canada, Japan, Europe, or the United States, and the respective CLAs are satisfied with the clinical evidence that is currently available. In that case, the clinical investigation is unnecessary to grant the import license. In these situations, post-marketing research on CLA might be necessary based on the assessment and advice of the subject expert committee.

Postmarket surveillance - Following the release of a medical device, the manufacturer must submit a vigilance report or PMS data. The reporting procedure, the complaints received, and the corrective and preventive measures taken should all be included in this report.

To test the safety and functionality of an investigational medical device that does not yet have its predicate device, manufacturers must carry out a post-marketing clinical investigation (which may include additional drug-device interactions, safety studies, investigations intended to support use under the approved indication, such as mortality or morbidity studies, etc.).

The medical device regulatory approval procedure in India

This is merely a condensed summary of the primary registration procedures.

Step 1: Using the published classification lists from the CDSCO, ascertain the device's classification.

Step 2: Designate an India Authorised Agent to take care of your device registration and communicate on your behalf with the CDSCO.

Step 3: Prepare to send the device application and any necessary supporting documentation to the CDSCO.

Step 4: Send in the application cost. After reviewing the application, the CDSCO might ask for more details.

Step 5: Your device will receive an import license from CDSCO after they approve it.

Conclusion:?The introduction of the Indian Medical Device Rules, 2017, by the Central Drug Standard Control Organisation (CDSCO), marked a crucial step in regulating medical devices, covering various aspects. In the coming years, stakeholders in the Indian healthcare industry, including manufacturers, regulators, and healthcare professionals, must continually collaborate to refine and enhance the regulatory landscape. This will not only align with global standards but also ensure that the Indian medical device market remains a competitive and reliable player on the international stage, contributing significantly to the overall growth and development of the healthcare ecosystem in the country.

around the world, is well-equipped to assist manufacturers in registering Class A medical devices in India.

Here's how Medfins can help streamline the Class A medical device registration:

1. In-depth Knowledge of Regulatory Landscape: Medfins comprehensively understands the Indian regulatory framework, including the requirements outlined by the Central Drug Standard Control Organisation (CDSCO). This knowledge ensures manufacturers receive accurate guidance tailored to the criteria for Class A medical devices.

2. Initial Assessment and Classification: Medfins can conduct an initial assessment to determine if your medical device falls within the Class A category according to CDSCO definitions. This is a crucial step in understanding the regulatory pathway and requirements applicable to your device.

3. Documentation Preparation: The team at Medfins will guide manufacturers in preparing the necessary documentation, ensuring that all required information is accurate and compliant with CDSCO regulations.

4. Form Submission and Communication: Medfins can assist in submitting the completed forms to the CDSCO and facilitate communication with the regulatory authorities on behalf of the manufacturer. This ensures that the submission process is efficient and that any queries or additional information requests are promptly addressed.

5. Authorized Agent Appointment: ?For importers, Medfins acts as an authorized agent who is required to import medical devices. This agent is a liaison between the manufacturer and the Indian regulatory authorities.

6. Audit Preparation and Support: In cases where manufacturing sites require an audit, Medfins can assist in preparing for the audit by ensuring that the site complies with the necessary standards, such as ISO 13485. This proactive approach helps manufacturers navigate the audit process smoothly.

7. Adaptation to Regulatory Changes: Medfins stays abreast of any updates or changes in the regulatory landscape. This ensures that manufacturers receive timely information and can adapt their processes to comply with new requirements, keeping their registrations current and compliant.

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