Get Your Medical Device License and Registration in India Today!
In Accordance with Medical Device Rule
The Indian medical device industry is one of the fastest-growing sectors in the country. To ensure the safety and quality of medical devices sold in India, the government has implemented a set of rules and regulations known as the Indian Medical Device Rules, 2017.
The Medical Device Rules is a comprehensive and detailed set of regulations that covers all aspects of medical device manufacturing and distribution, from design and development to manufacturing, testing, packaging, labeling, and distribution. The regulations cover the entire life cycle of the medical device, from design and development to post-market surveillance.
The Medical Device Rules defines medical devices according to their complexity and risk. It categorizes medical devices into three classes: Class A (low risk), Class B (medium risk), and Class C (high risk). For each class, the Medical Device Rules specifies a set of standards and requirements for their manufacture, sale, distribution, and use.
Manufacturers of medical devices in India are required to register their products with the Central Drugs Standard Control Organization (CDSCO). To be registered, manufacturers must provide evidence that their devices comply with the required standards and requirements.
Online Application for Medical Device License and Registration
MedDev Experts can help you with the entire application process, from start to finish. Our experienced staff will guide you through the Medical Device License and Registration process and ensure that your application is complete and accurate. We will also help you to comply with all of the necessary regulations.
for online application and requirement of Medical Device License and Registration
Deadlines for Medical Device License and Registration in India
- Class A or B medical devices: October 1, 2022
- Class C or D medical devices: September 30, 2023
- Distributor, Wholesaler and Retailer: September 30, 2022
Do you need a medical device license and registration?
Get help from MedDev Experts to get your medical device license and registration quickly and easily.
We understand that applying for a medical device license can be a challenging task. That’s why we’re here to help. We have years of experience helping businesses get the licenses they need, and we can make the process as smooth and stress-free as possible for you.
We’ll walk you through every step of the online application process, from gathering the necessary paperwork to submitting your application. We’ll also answer any questions you have along the way.
We’re committed to helping you get your medical device license and registration as quickly and easily as possible. Contact us today to learn more about our services.
Do you manufacture or want to start manufacturing Class A or Class B medical devices?
If so, you need to obtain a Medical Device License (MD 5) from the State Drug Controller. MD 5 is a mandatory requirement for all manufacturers of Class A or B medical devices in India.
Class A medical devices are those that pose minimal risk to patients and may be sold without a prescription. Examples of Class A medical devices include bandages, face masks, thermometers, blood collection tubes, etc.
Class B medical devices are those that pose a moderate risk to patients and require a prescription from a healthcare professional before they can be sold. Examples of Class B medical devices include hearing aids, dental bonds, gloves, chemical chemistry reagents, self-testing kits like glucose test, human chorionic gonadotropin (hCG), luteinizing hormone, etc.
The application for an MD 5 license can be submitted through the online portal of the Central Drugs Standard Control Organization (CDSCO). The application process is simple and straightforward. You will need to provide information about your company, the medical devices you manufacture, the device master file, and the manufacturing facilities you use.
If you have any questions or need more information about the MD 5 license, please don’t hesitate to contact us. We would be happy to help you through the process.
Get the MD 9 License and start manufacturing Class C or D medical devices in India today.
The MD 9 license is a mandatory requirement for all manufacturers of Class C or D medical devices in India. The application for an MD 9 license can be submitted through the online SUGAM Portal of CDSCO.
Class C medical devices are the highest risk level of medical devices in India and require the most stringent regulation. Class D medical devices are those that are used in the diagnosis, treatment, mitigation, or prevention of disease or injury in humans.
We can help you get your MD 9 license quickly and easily. We have years of experience helping businesses get the licenses they need, and we can make the process as smooth and stress-free as possible for you.
Contact us today to learn more about our services for Medical Device License and Registration.
Get your Medical Device Import License today and start importing medical devices into India.
The import of medical devices in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. All medical devices, including active implantable medical devices, must obtain an import license from CDSCO before they can be imported into India.
The import license is granted after the CDSCO has evaluated the device and determined that it complies with the Indian medical device regulations. The application for an import license can be submitted through the online SUGAM Portal of the CDSCO.
We can help you get your import medical device license quickly and easily. We have years of experience helping businesses get the licenses they need, and we can make the process as smooth and stress-free as possible for you.
Contact us today to learn more about medical device import license.
Get Your Medical Device Test License in India to Start manufacturing medical devices for clinical investigations, test, evaluation, examination, demonstration or training today.
To obtain a test license, an application must be submitted in Form MD 12 to the CDSCO. The CDSCO is the Licensing Authority to grant Test License for medical device in Form MD 13.
We can help you get your medical device test license quickly and easily. We have years of experience helping businesses get the licenses they need, and we can make the process as smooth and stress-free as possible for you.
Contact us today to learn more about our services for Medical Device Test License.
Get Your Medical Device Wholesale License in India to start selling, stocking, exhibiting, offering for sale, or distributing medical devices today.
Any person who intends to sell, stock, exhibit, offer for sale, or distribute a medical device including in vitro diagnostic medical device, must obtain a registration certificate from the State Licensing Authority.
The application for a registration certificate can be submitted in Form MD 41 to the State Licensing Authority. The license will be granted on Form MD 42 by the Authority.
We can help you get your medical device wholesale license quickly and easily. We have years of experience helping businesses get the licenses they need, and we can make the process as smooth and stress-free as possible for you.
Contact us today to learn more about our services for Medical Device Wholesale License.
