CDSCO
Regulatory Services for Importers
Seamless Entry, Regulatory Excellence: Your Partner in Navigating Medical Device Compliance for Import Success
Medical Device Imports: A Reform-Driven Growth Sector
Unlock the potential of India's booming medical device market! With our deep understanding of the updated Indian regulations, we empower global companies to navigate this dynamic landscape with ease. Our expertise ensures seamless compliance, enabling swift and hassle-free market entry. Partner with us to capitalize on opportunities in India's rapidly evolving healthcare sector.
Regulatory framework explained
Foreign manufacturers seeking to enter India’s medical device market cannot directly apply to the Central Drugs Standard Control Organisation (CDSCO) for an import license. Instead, the application must be routed through an authorized licensing agent holding a valid import license under Forms 20B and 21B.
At CliniExperts, we serve as trusted medical device regulatory consultants, equipped with a valid import license (Forms 20B and 21B). We streamline the import process for international manufacturers, ensuring quick and hassle-free entry into the Indian market, accelerating their business success.
Device Classification:
- Class A: Low-risk items (e.g., absorbent cotton wool)
- Class B: Low-moderate risk items (e.g., thermometers)
- Class C: Moderate-high risk items (e.g., implants)
- Class D: High-risk items (e.g., heart valves)
Import License Application Process
The licensing process has been streamlined and expedited to facilitate the swift market launch of medical devices. Documentation and procedures are now aligned with international standards and conventions, ensuring a unified and simplified approach. Securing a medical device import license involves four essential steps:
The medical device needs to be classified appropriately. This means determining the category and risk level of the device.
An authorized agent, who acts as a representative for the manufacturer, must be appointed.
The third step involves filing the application for the import license, providing all the necessary documentation and information.
Finally, upon successful completion of the preceding steps, the license to import the medical device is obtained.
These steps ensure that the importation process is in compliance with regulations and that the medical devices meet the required standards for safety and effectiveness in the destination country.
Regulatory Framework as per Classification of Products
Class A, B, C, and D Devices
Foreign manufacturers aiming to enter the Indian market cannot directly apply to the CDSCO for an import license. Instead, they must engage an authorized licensing agent. The agent submits the application to the CDSCO under Form MD-14, and upon successful verification, the import license is granted under Form MD-15. This process applies to all device classes.
New Medical Devices
For new medical devices, a three-stage approval process is mandatory across all device classes:
Clinical Investigation Permission
- Application submitted under Form MD-22
- Permission granted under Form MD-23
Import License
- Application submitted under Form MD-26
- License issued under Form MD-27
Test License
- Application submitted under Form MD-16
- License granted under Form MD-17
Why Choose Shen Clinical Services?
Invest in Trusted Excellence of Shen Clinical Services to unleash the Potential of Indian Medical Device Manufacturing.
Contact our team to get the best support for regulatory services in India
Existing Devices
Applicant
Risk/Class
Type of License
Forms
Importer
A, B, C, D
Type of License
Application: MD-14
Permission: MD-15
Manufacturer
A, B
Manufacturing License
Application: MD-3
Permission: MD-5
-----
C, D
Manufacturing License
Application: MD-14
Permission: MD-15
Existing Devices
Applicant
Risk/Class
Type of License
Forms
Importer
A, B, C, D
Type of License
Application: MD-14
Permission: MD-15
Manufacturer
A, B
Manufacturing License
Application: MD-3
Permission: MD-5
-----
C, D
Manufacturing License
Application: MD-14
Permission: MD-15
Shen Clinical Services – With You, All The Way
In 2018, approximately 15,998,700 lives were lost in India due to inadequate quality of healthcare. These alarming figures are expected to decline significantly with the implementation of a reforms-driven regulatory framework. Shen Clinical Services plays a pivotal role in this transformation, guiding overseas companies through the regulatory maze with a dedicated team, cutting-edge expertise, and a proven track record as a single-window solution for medical device importers.
To date, we have successfully supported over 206 importers, earning their trust and satisfaction. Here’s what two of our valued clients have to say—testimonies that will inspire you to take the next step with us.
Related Services
SUGAM REGISTRATION
Importer | Regulatory Body: CDSCO
Importers of medical devices seeking to obtain a registration or import license can complete the process on the SUGAM portal.
The registration for medical devices is primarily handled through the SUGAM portal, an online platform where applicants can apply for license approvals, FSC, and registration numbers.
AUTHORIZED AGENT
Importer | Regulatory Body: CDSCO
A foreign company without an establishment in India, wishing to enter the Indian market, can appoint an authorized agent to handle the registration and marketing of its products. An “Authorized Agent” refers to a person or entity in India designated by the foreign company.
The authorized agent will be responsible for managing the import and business operations of the foreign company in India, ensuring full compliance with the provisions of the Drugs and Cosmetics Act in all aspects.
IMPORT LICENSE APPLICATION AND APPROVAL
Importer | Regulatory Body: CDSCO
Over the past two decades, India has become a global leader in medical device manufacturing. The Central Drugs Standard Control Organization (CDSCO) is the authorized regulatory body responsible for approving applications for the importation of medical devices into India. To obtain a medical device import license, companies must complete Form MD-14 and submit it to the CDSCO for approval.
IMPORT LICENSE FOR NEW MEDICAL DEVICES
Importer | Regulatory Body: CDSCO
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for granting permission to import new medical devices, through Forms MD-26 and MD-27. To obtain an import or manufacturing license for the sale or distribution of a medical device without a predicate device, the manufacturer or importer must submit an application to the Central Licensing Authority. The application must be made through an authorized agent who holds a valid manufacturing or wholesale license for the sale or distribution of medical devices.
Frequently Asked Questions
Is it possible for multiple importers to handle the same product?
Yes, there can indeed be multiple importers for the same product, provided that all applicants meet the criteria outlined for submitting their applications.
What are the fees for a manufacturing site if importers wish to register devices belonging to multiple classes (A, B, C, or D)?
According to the Second Schedule, manufacturers are required to submit specific fees for different classes of medical devices. If an organization manufactures products across multiple classes, the fees associated with the highest class among them need to be paid.
If the first importer has obtained approval for a new investigational medical device, do subsequent applicants also need approval, or can they simply apply for an import license?
If the initial importer has already obtained approval for a new investigational medical device, subsequent applicants can proceed by solely applying for the import license for the same medical device without the need for additional approval.
Why would I require authorized agent support?
For a foreign company aiming to market its product in India, the primary requirement is the registration of products through an Indian establishment. Foreign companies lacking an Indian establishment or local partners must engage an authorized agent to manage the import of products into India on their behalf.
How will I benefit from appointing you as my authorized agent instead of my existing distributor in India?
To kickstart operations in India, only a single Indian establishment is required. If you opt to change your distributor after initial registration, the registration process would need to be repeated. However, by partnering with CliniExperts, registration is a one-time process. This allows flexibility to add or switch distributors as necessary without going through the registration procedure repeatedly.