Medical Device Registration in India
Medical Device Registration in India
In India, medical device regulation falls under the Central Drug Standard Organization (CDSCO), which operates within the Ministry of Health's jurisdiction. The legal framework for medical products is grounded in the Drugs and Cosmetics Act of 1940, a piece of pre-independence legislation. Since its inception, the Indian government has been continuously revising these laws to keep pace with advancements in healthcare technology, including medical devices, software, and soon, the influence of artificial intelligence in healthcare.
The introduction of the Medical Device Rules (MDR) in 2017 marked the first time India established a formal classification system for medical devices. These rules were subsequently updated with the Medical Device (Amendment) Rules in 2020.
To register a medical device in India, a manufacturer needs to consider the following aspects:
.⦁ Selection of License Holder: Determine who will be designated as the License Holder for the medical device.
⦁ Classification of Medical Devices: Understand the classification system for medical devices in India..
⦁ Predicate and Global Approvals: Identify if the product has a predicate in the market and assess how existing global approvals influence the registration process..
⦁ Required Documentation and Costs: Gather the necessary documents and understand the costs involved in obtaining approval..
⦁ Approval Timelines: Be aware of the timelines associated with the approval process.
Who should be chosen as the license holder?
In India, the license holder must be a local Indian entity. Therefore, manufacturers need to select this entity as part of their initial market entry strategy for India. Even companies that have been operating in India for some time need to make this decision, especially if they have previously sold medical devices that were not regulated but now require registration under the MDR, 2020 Rules.
The license holder could be a local subsidiary, an Independent Agent, or a Distributor. Appointing an Independent Agent as the license holder offers manufacturers a cost-effective and secure way to ensure compliance, while still allowing them commercial flexibility in working with their trusted distribution partners.
The license holder must be a legally registered business in India, possessing either a Wholesale Drug License or an MD-42 Medical Device Registration Certificate, as well as a SUGAM account for submitting documents to the CDSCO. Additionally, the entity must have an Import Export (IE) Code, GST Number, and all necessary statutory licenses for the import and trade of medical products in India.
How are medical devices classified in India?
The MDR guidelines in India provide detailed instructions for the classification of medical devices. The CDSCO offers comprehensive product lists that include Generic Names, Intended Use, and Classification to assist manufacturers in determining the appropriate class for their devices in India.
The classification system in India is akin to the EU MDR classification and can serve as a reference point for manufacturers to understand how their devices will be categorized in India.
Does the product have a predicate in the market? What is the impact of current global approvals for product registration?
If a medical device has a predicate product that is substantially equivalent and has received approval from a GHTF (Global Harmonization Task Force) member country, it can simplify the approval process in India. Therefore, manufacturers should consider the following when planning their registration to potentially reduce the time and cost involved in obtaining an Import License: Substantially Equivalent Predicate: This refers to a medical device that has been approved in India and is comparable to the device being applied for, in aspects such as material, intended use, and design. GHTF Countries: Approval from countries such as Australia, Canada, Europe, Japan, the United Kingdom, and the United States can facilitate the registration process. If your device does not meet these criteria, the CDSCO may require additional review processes or steps, possibly involving a Special Expert Committee (SEC) or a Medical Device Advisory Committee (MDAC). MedEnvoy can help manufacturers prepare their clinical data for these reviews.
What are the documents and costs associated with obtaining approval in India?
Once an Indian Agent is appointed and the class of the medical device is determined, an application must be submitted on the SUGAM portal for CDSCO registration. This includes providing an MD-14 application form, which details information about the device such as Generic Name, Brand Name, Intended Use, Material of Construction, Model Numbers, and Accessories.
Documents required for submission include certifications (like ISO 13485, Free Sale Certificate, Declaration of Conformity), Manufacturing Site details (Plant Master File), and Technical File (Device Master File). All documents must be in English. The final step involves paying the CDSCO fees to complete the submission process. A comprehensive list of required documents for the MD-14 application is available in the linked article. The requirements are similar to those of GHTF countries and can be readily fulfilled if your device is already approved in one of those markets.
After the dossier is submitted, the CDSCO will review the documents and may raise queries. Upon satisfactory responses to these queries, the CDSCO will issue an MD-15 Import License, which allows the export of the medical devices to India.
Categories of Medical Licenses:-
In India, medical devices are categorized into various classes to determine the level of regulatory scrutiny required. The classification system is defined under the Medical Device Rules (MDR), 2017, and the Medical Device (Amendment) Rules, 2020. Here’s a brief overview of the categories:
| Category | Discription | Example |
|---|---|---|
|
Class A (Low Risk)
|
Devices with minimal risk to the patient. These are typically low-risk medical devices.
|
Bandages, non-invasive gloves, bedpans, and thermometers |
|
Class B (Moderate Risk) |
: Devices with a moderate risk to the patient. They have a greater potential for harm compared to Class A devices but are still considered moderate risk.
|
Blood pressure monitors, wheelchairs, and infusion pumps.
|
|
Class C (High Risk) |
Devices that present a higher risk to the patient and typically require a more detailed regulatory review. These devices are essential for patient safety and have more stringent regulatory requirements.
|
Surgical drapes, anesthesia machines, and ventilators.
|
|
Class D (Highest Risk) |
Devices with the highest risk to the patient, often involving life-support or life-sustaining capabilities. These require extensive regulatory oversight and documentation.
|
Heart valves, pacemakers, and implantable defibrillators.
|
Key Points in Classification:
Classification Basis: The classification is generally based on factors such as the intended use of the device, its duration of contact with the body, the degree of invasiveness, and the potential risk associated with its use.
Regulatory Requirements: Higher-class devices typically require more comprehensive documentation, clinical data, and testing to ensure safety and efficacy.
Fee for Medical Devices
In India, the fees associated with the registration of medical devices are structured based on the class of the device and the type of application. These fees are payable to the Central Drugs Standard Control Organization (CDSCO) and are outlined in the Medical Device Rules, 2017, and the Medical Device (Amendment) Rules, 2020. Here is a general overview of the fees you can expect:
| Category | Fees | Renewal |
|---|---|---|
|
Class A (Low Risk)
|
Approximately ₹25,000 - ₹30,000
|
Similar to the application fee, subject to periodic updates by CDSCO.
|
|
Class B (Moderate Risk) |
Approximately ₹50,000 - ₹60,000
|
Similar to the application fee, subject to periodic updates by CDSCO.
|
|
Class C (High Risk) |
Approximately ₹75,000 - ₹100,000
|
Similar to the application fee, subject to periodic updates by CDSCO. |
|
Class D (Highest Risk) |
Approximately ₹100,000 - ₹150,000
|
Similar to the application fee, subject to periodic updates by CDSCO.
|
Frequently Asked Questions
EPR (Extended Producer Responsibility) is essential that manufacturers and recyclers manage any kind of product waste. It ensures and emphasis on environmental sustainability through holding producers accountable for recycling and proper disposal, promoting a circularity
In EPR registration there all types of battery categories are mentioned Ex: Portable Battery, Automotive Battery, Industrial Battery, Electric Vehicle Battery, battery waste composition (Lead acid battery, Lithium Ion battery) Etc.
CPCB (Central Pollution Control Board) grants the EPR Battery waste Certificate under battery waste management (amendment) rules 2024.
"EPR (Extended Producer Responsibility) obligations dictate that manufacturers manage their product waste. Compliance with EPR regulations ensures environmental sustainability, promotes responsible waste management, and fosters a culture of corporate accountability, contributing to a healthier planet for future generations."
In EPR battery waste management rules, 2022 emphasis on preventing environment incinerators from landfills of used batteries. Besides these rules said that we must collect all battery waste and deliver it for recycling and refurbishing for re-use or use in other business.
Choose our service for unparalleled excellence for EPR Registration for battery waste online. With a commitment to innovation, reliability, and customer satisfaction, we deliver solutions tailored to your needs, ensuring success in 3 simple steps:
- Details & Documents
- Submission of application on battery waste portal.
- Obtaining EPR battery waste certificate.
