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Medical Devices Regulations and Licensing in India
Welcome to Satori OCS LLP, your premier destination for comprehensive Medical Devices Regulatory and Licensing Consultancy Services. In a country renowned for its burgeoning healthcare sector and an ever-increasing demand for innovative medical devices, navigating the intricacies of regulatory compliance and licensing can be a daunting task. We understand the unique challenges and opportunities that India presents in this dynamic field, and we are here to be your trusted partner on this regulatory journey. With a team of seasoned experts, a deep understanding of India's regulatory landscape, and an unwavering commitment to excellence, we are poised to simplify the complexities, streamline the processes, and ensure your medical devices meet all necessary requirements for market entry and success in the vibrant Indian healthcare ecosystem. Discover how Satori OCS can help you unlock the vast potential of the Indian market while ensuring compliance and patient safety are at the forefront of your endeavors.
The Market for Medical Devices in India
With a significant contribution from Medical Devices imports, India is currently one of the largest international markets for medical devices. When compared to other countries, India is a major importer of medical devices, providing consistent market opportunities for international medical device manufacturers. The market for medical devices is expanding quickly in India due to the country's rising need for healthcare amenities. India has one of the major medical device industries in Asia and is home to some of the top 20 companies worldwide. This sector has enormous potential in terms of a competent workforce, research and development, and capital intensity. A few programs have been developed by the government to expand the Indian market for medical gadgets. Medical device sales in India are predicted to increase at a compound annual growth rate (CAGR) of 37%, from $10.36 billion in 2020 to $50 billion in 2025. India imports medical devices from several important countries, including the US, Singapore, China, Brazil, and many more.
What are Medical Devices ?
As per Indian Medical Devices Rules 2017 “Medical Device” means:
- Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub- clause (i).
Classification of Medical Devices as per Indian Medical Devices Rules 2017
Medical devices other than in vitro diagnostic medical devices classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely: -
- Low risk
- Low moderate risk
- Moderate high risk
- High risk
- Class B
- Class C
- Class D
In vitro diagnostic medical devices classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely: -
- Low risk
- Low moderate risk
- Moderate high risk
- High risk
- Class B
- Class C
- Class D
Aligning with the principles outlined by the International Medical Device Regulators Forum (IMDRF), a risk-based classification for medical devices and in-vitro diagnostic devices (IVDs) was incorporated in Indian Medical Device Regulation 2017.
Low-Risk
Absorbent cotton wools dressing alcohol swab etc.
Low-Moderate Risk
Thermometer BP monitoring devices disinfectants etc.
Moderate-High Risk
Implants hemodialyis catheter
etc.
High-Risk
Angiographic guide wire Heart valve.
Licensing Authorities for Grant of Licenses for Medical Devices and Invitro Diagnostic (IVDs) Agents in India
Manufacture, Import, Sale or Distribution of Medical Devices and In-vitro Diagnostics (IVD) agents in India are regulated by the Indian Medical Devices Rules 2017. These rules were introduced by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory authority for medical devices and pharmaceuticals in India governed under Drugs and Cosmetics Act 1940.
“Central Licensing Authority” means the Drugs Controller General of India (DCGI) appointed by the Central Government as per Drugs and Cosmetics Act, 1940, and Rules made there under. The Central Licensing Authority oversees the issuance of Import Licence for all Classes of Medical Devices and IVD agents, Manufacturing License and Loan License for Class C and Class D Medical Devices and IVD agents.
“State Licensing Authority” means the State Drugs Controller appointed by the State Government as per Drugs and Cosmetics Act, 1940, and Rules made there under. The State Licensing Authority is responsible for granting Sale or Distribution Licence for all Classes of Medical Devices and IVD agents, Manufacturing License and Loan License for Medical Devices and IVD agents falling under Class A and Class B categories.
Indian Medical Devices Rules 2017
Key features and highlights of the Indian Medical Devices Rules 2017 include:
-
Classification
The rules establish a classification system for medical devices based on their risk levels, similar to international practices. Medical devices are categorized into Classes A, B, C, and D, with higher-risk devices falling under higher classes.
-
Regulatory Approval
Depending on the class of the device, manufacturers and importers may need to obtain regulatory approval from the CDSCO before placing their products on the market. Higher-risk devices generally require more rigorous assessment.
-
Registration
Manufacturers and importers of certain medical devices are required to register their products with the CDSCO. The registration process involves submitting detailed technical information and documentation about the device.
-
Manufacturing and Quality Standards
The rules emphasize compliance with quality management systems and manufacturing standards. Manufacturers must adhere to Good Manufacturing Practices (GMP) and maintain proper quality control procedures.
-
Labeling and Packaging
Specific requirements for labeling and packaging of medical devices are outlined, including instructions for use, warnings, and other necessary information for users.
- Import and Export
The rules govern the import and export of medical devices, outlining requirements and procedures for obtaining import licenses and meeting customs regulations.
- Post-Market Surveillance
The rules establish provisions for post-market surveillance, including reporting adverse events, recalls, and corrective actions to ensure the safety and efficacy of medical devices on the market.
- Notified Bodies
The rules establish a process for designating Notified Bodies in India to assess and verify the conformity of certain high-risk medical devices.
Navigating Medical Device License in India
Navigating the process of obtaining a medical device license in India can be complex, but it's essential to ensure compliance with Indian regulatory requirements.
Here are the general steps involved:
-
Determine the Classification of the Medical
Device
Medical devices in India are categorized into four classes (Class A, Class B, Class C, and Class D) based on their intended use and risk level. Class A devices have the lowest risk, while Class D devices have the highest risk.
GET IN TOUCH
-
Select a Licensing Authority
Choose the appropriate licensing authority based on your device classification.
- The State Licensing Authority: Grants Manufacturing License and Loan License for Class A and Class B Medical Devices and IVD agents.
- The Central Licensing Authority: Grants Manufacturing License and Loan License for Class C and Class D Medical Devices and IVD agents.
-
Quality Management System (QMS)
Ensure that your manufacturing processes adhere to the required QMS. Compliance with ISO 13485 or an equivalent quality management system is often necessary for medical device manufacturers.
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Preparation of Technical Documentation
Create and compile all necessary technical documentation required for the license application. This includes details of the device's design, specifications, labeling information, manufacturing details, and clinical trial data (if applicable).
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Testing and Certification
Depending on the class of the device, you may need to get your medical device tested and certified by a recognized laboratory. The certification process verifies that your device meets safety and efficacy standards.
GET IN TOUCH
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Submission of Application
Submit the license application along with the prescribed fee and required documents to the chosen licensing authority. The application should be submitted online through the Online System for Medical Devices (OSMD) portal. This application should include all required documentation, such as the manufacturing and quality control information, clinical data, and labeling details.
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Review and Evaluation
The licensing authority will review the application and assess the documents for compliance with regulatory requirements. This process may involve a thorough examination of your Quality Management System (QMS) and clinical data. They may request additional information or clarification during this stage.
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Site Inspection
Depending on the class of the device and assessment of the licensing authority, it may conduct an inspection of the manufacturing facility to ensure that it complies with the Good Manufacturing Practices (GMP) and quality standards.
GET IN TOUCH
-
Approval and License Issuance
If the application and inspection are satisfactory, the licensing authority will issue a manufacturing license for the medical device. The license is typically valid for a specific period and needs to be renewed periodically.
GET IN TOUCH
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Post-Market Surveillance
After obtaining the license, manufacturers are required to comply with post-market surveillance requirements and monitoring the safety and performance of the medical devices in the market. This includes adverse event reporting, product recalls if necessary and maintaining ongoing compliance with regulations.
It is advisable to consult with regulatory expert or consultant familiar with Indian medical device regulations to ensure compliance with current requirements and to navigate the licensing process successfully.
Navigating Import Licence for Medical Devices to India
Importing medical devices to India requires obtaining an Import Licence from the Central Drugs Standard Control Organization (CDSCO). Here is a step-by-step guide on how to navigate the import licence process for medical devices in India:
- Determine the Category of Medical Device
Medical devices are classified into different categories based on their risk level. It is essential to identify the appropriate category for your device as it determines the regulatory requirements and licensing process. - Appoint an Authorized Indian Agent
Non-Indian manufacturers are required to appoint an authorized Indian Agent who will act as a representative for all regulatory processes. The agent should have a valid Wholesale Drug License. - Obtain an Import-Export Code (IEC)
Before applying for an import licence, you need to obtain an Import-Export Code (IEC) from the Directorate General of Foreign Trade (DGFT). This code is mandatory for all importers and exporters in India. - Prepare Necessary Documents
Gather all the required documents for the import licence application. These may include:
- Covering letter stating the intent of import.
- Duly filled Form 40 (application form).
- Manufacturer's Free Sale Certificate or Certificate to Foreign Government.
- Product information, including technical specifications, intended use, and labeling details.
- Authorization letter from the manufacturer appointing the Indian agent.
- Power of Attorney given by the manufacturer to the Indian agent.
- ISO 13485 certification or equivalent.
- GMP certificate or equivalent.
- Device master file (if applicable).
- Test reports and clinical data (if applicable).
- Submit the Application
Submit the completed application along with all the necessary documents to the CDSCO office in New Delhi. You can also submit the application online through the SUGAM portal. - Pay the Fees
Pay the required fees for the import licence application. The fee structure varies based on the category and risk level of the medical device. - Review and Inspection
The CDSCO will review your application and documents. They may conduct an inspection of your manufacturing facility or request additional information if needed. - Import Licence Issuance
Once the CDSCO is satisfied with the application and all requirements are met, they will issue the import licence. The validity of the licence depends on the category of the medical device. - Customs Clearance
After obtaining the import licence, you can proceed with customs clearance for importing the medical devices into India. Ensure compliance with all customs regulations and pay any applicable customs duties. - Post-import Compliance
After importing the medical devices, ensure compliance with all post-import requirements, such as labeling, storage, distribution, and reporting adverse events to the CDSCO.
The specific requirements and procedures may vary depending on the category and risk level of the device. It is advisable to consult with a regulatory expert for accurate and up-to-date information.
At Satori OCS, we are dedicated to simplifying the intricate journey of obtaining medical device licenses and ensuring regulatory compliance in India. Our team of experts stands ready to guide you through the complexities, streamline the processes, and offer unwavering support as you navigate the Indian healthcare landscape. With our commitment to excellence and your vision for innovation, together, we can bring safe and effective medical devices to the Indian market, contributing to improved healthcare outcomes and a healthier future. Contact us today to embark on a successful regulatory journey, where your aspirations meet our expertise.
FAQs
Q1. Are there different regulatory requirements for In-Vitro Diagnostic (IVD) devices in India?
Yes, IVD devices have specific regulatory requirements in India, including classification, registration, and quality standards.
Q2. Is post-market surveillance required for medical devices in India?
Yes, manufacturers and importers are responsible for post-market surveillance to monitor the safety and performance of medical devices. Adverse event reporting is mandatory.
Q3. How are medical devices classified in India?
Medical devices are classified into four classes (Class A, B, C, and D) based on their potential risk to patients and users. The classification determines the regulatory requirements.