INDIA MEDICAL DEVICE REGULATORY LANDSCAPE

1. INDIA MEDICAL DEVICE REGULATORY LANDSCAPE SEP 2023 www.insights10.com

2. Medical Device Regulatory Services Class-A Manufacturers Class-B Import License Test License Authorized Agent Shpport MEDICAL DEVICES Class-D Class -C Importer Permission to Manufacture Test License The Indian Government has consistently focused on the oversight and regulation of Medical Devices. As medical technology advances and the demand for these devices grows rapidly in the country, new regulations have been implemented. These devices are now classified into four categories: A, B, C, and D, each overseen by specific central and state regulatory authorities. The categoriza- tion is based on the level of associated risk, and the appli- cation process for licenses has been made relatively straightforward by regulatory bodies. Additionally, the gov- ernment has established guidelines for the import of medical devices. The key re- quirement for obtaining a license is to have an autho- rized Indian agent to facilitate the application. Thanks to government initia- tives like the SUGAM portal, the process of acquiring medical device licenses has become more efficient. Here at Insights10, we are dedicat- ed to assisting our clients with medical device regulatory services, including guidance and support throughout the application and licensing pro- cedures for Medical Devices.

3. New Device - First Time in India Manufacturer&Importer Class -C Class-A Class-B Import / Manufacturing License MEDICAL DEVICES Test License Class-D Authorized Agent Shpport Clinical Investigation Permission In accordance with governmental regulations, a medical device that has not been previously listed in the medical devices catalog of the Central Drugs Standard Control Organization (CDSCO) is categorized as a new medical device. Additionally, devices that are already registered but seek to make new claims based on various implementation factors will also be classified as new devices.

4. Classification of Medical Devices in India In line with the most recent reforms, medical devices have been categorized into four primary classifications according to their level of usage risk. Furthermore, these cate- gories are then subdivided into surgical and non-surgical equipment groups. RISK BASED MEDICAL DEVICES CLASSIFICATION Class A Low Class B Class C Class D Low-Moderate Moderate-High High Medical devices have been categorized into four distinct groups: A, B, C, and D, with the level of associated risk ascending from A to D. Devices with lower risk, such as thermome- ters, fall into the A category, while higher risk devices like pacemakers and heart valves are classified as D. Furthermore, these devices are subcategorized based on their invasiveness into surgical and non-surgical variants. It's important to note that obtaining a license for class A devices is a relatively straightforward process in comparison to the more complex procedure for class D devices.

5. Overview of Forms for Application The Central Drugs Standard Control Organization has developed a series of application forms to facilitate the submission of medical device license requests. These forms are tai- lored to align with the specific purpose of the application. They are distinct for importers and manufacturers, and are additionally categorized based on the varying risk levels asso- ciated with different types of medical devices. While applying for single medical devices is straightforward, the process becomes more intricate when seeking approval for multiple devices either for import or manufacturing, demanding a heightened level of attention. Applicant Risk/Class Type of Licence Forms Existing Devices Application: MD-14 Permission: MD-15 Importer Importer License A, B, C, D Application: MD-3 Permission: MD-5 Manufacture Manufacture License A, B Application: MD-4 Permission: MD-6 Application: MD-7 Permission: MD-9 Application: MD-8 Permission: MD-10 Loan License Manufacture License C, D Loan License Applicant Risk/Class Type of Licence Forms Clinical Investigation Permission Application: MD-22 Permission: MD-23 Importer A, B, C & D New Devices Application: MD-26 Permission: MD-27 Import License A, B, C & D Application: MD-16 Permission: MD-17 Application: MD-22 Permission: MD-23 Application: MD-26 Permission: MD-27 Test License A, B, C & D Clinical Investigation Permission Manufacture A, B, C & D Manifacturing License A, B, C & D Application: MD-16 Permission: MD-17 Test License A, B, C & D

6. For Importers Given India's status as a prominent global market and a rapidly growing economy, inter- national companies are increasingly aiming to secure a portion of the Indian medical device market. Consequently, the Indian govern- ment has taken steps to update its laws and regulations, fostering a more welcoming at- mosphere for medical imports. Regulatory bodies have introduced guidelines to incor- porate and categorize new medical devices in accordance with evolving global trends and technological advancements. Import License Process To facilitate the swift introduction of products into the market, the license issuance process has been stream- lined and expedited. The required doc- umentation and procedures have been standardized to adhere to international formats and conventions, thereby har- monizing and simplifying the processes involved. Classification of Medical Devices Authorized Agent / Registration Holder Support Application Filling (Form MD - 14) Import Licence (Form MD - 15)

7. For Manufacturer Indian Manufacturer Of Medical Devices ClassificationOfMedicalDevices For Class A & B For Class C & D State Licensing Authority Central Licensing Authority Application Filling (Form MD 3) Application Filling (Form MD 7) Manufacturing License (Form MD 5) Application Filling (Form MD 9) The authorities have recently introduced new rules and regulations governing the manufactur- ing of medical devices within India. The allocation of licensing authorities for submitting applica- tions differs according to the classification of the medical devices. Manufacturers intending to produce Class A and Class B medical devices will have their applications processed and licens- es granted by the State Licensing Authority. In contrast, applications from manufacturers seek- ing to produce Class C and Class D medical devices will undergo evaluation and authorization by the Central Licensing Authority. The Central Drugs Standard Control Organization (CDSCO) has also established predefined application fees for varying types of medical devices.

8. Investigational New Device/ New Device – First Time in India Conduct Clinical Investigation for Device (Form MD-22, Form MD-23) For For Manufacturer Importers Apply for Test License (Form MD- 16, Form MD- 17) Apply for Test License (Form MD- 12, Form MD- 13) Application to Import/Manufacture New Medical Device-First time in India (Form MD- 26) Permission to Import/Manufacture New Device grabted (Form MD- 27) PROCESS FOR NEW MEDICAL DEVICES – FIRST TIME IN INDIA A novel medical device that lacks a comparable or precursor in India, or an existing medical device with alterations in design or intended application, is required to establish its safety prior to pursuing a license. To fulfill this requirement, a clinical investigation involving human participants must be conducted. This investigation aims to assess the medical device's safety and effective- ness. Upon the successful completion of the clinical investigation and confirmation of the de- vice's safety profile, an application can be submitted to the Central Licensing Authority (CLA) for either importing or manufacturing the newly researched medical device.