Experienced Team

Our deep experience enhances both the quality and integrity of our approach to navigating Indian regulatory services, guiding its successful path.

Guaranteed Privacy

For medical devices, in-vitro diagnostics, cosmetics, new drugs, veterinary, or biological products, we ensure the strict confidentiality of all data.

Regulatory Insights

Leveraging our deep understanding of the regulatory landscape, we expertly navigate CDSCO licensing to drive success.

Success Man

We Understand Our Clients Needs!

Each successful application conversion to regulatory approval enriches our understanding of current regulations and compliance requirements. Our meticulous attention to detail and adherence to regulatory standards minimize the risks of non-compliance, ensuring the best outcomes for our clients.

Key Aspects of CDSCO Licensing

...
DRUGS

We provide comprehensive assistance for obtaining Drug Manufacturing licenses, Import licenses, Fixed Dose Combination (FDC) licenses, New Drug licenses, Subsequent New Drug

...
MEDICAL DEVICE

We provide tailored regulatory solutions for compulsory licensing of notified and non notified medical devices, voluntary registration for Class A, B, C, and D medical devices, and new medical device registrations. Read More.

...
IN-VITRO DIAGNOSTICS

Under CDSCO registration, you are authorized to manufacture, sell, and import IVD devices. Our proactive regulatory services ensure a seamless registration process for your IVD products. Read More.

Drugs: Registration Certificate and Import License

Medical Device : CDSCO Medical Device Classification

Under the Medical Devices Rules 2017, classification of medical devices is based on the intended use and the potential harm they can cause

Class A
(Low Risk):

01

It covers stethoscopes, bandages, and other basic medical instruments, causing no potential harm to humans.

Class B
(Low-to-Moderate Risk):

02

It covers blood pressure monitors, needles, and syringes that may cause harm to patients if not used properly.

Class C
(Moderate-to-High Risk):

03

It includes artificial heart valves, atheters, and orthopedic implants, having the potential to cause injury if malfunctioning.

Class D
(High Risk):

04

It includes artificial heart valves, atheters, and orthopedic implants, having the potential to cause injury if malfunctioning.

Medical Device: Licensing & Registration Requirement

India’s medical device market ranks among the top 20 globally, with approximately 70% of devices being imported. As a leading regulatory service provider, we understand the complexities of FDA medical device registration and the essential Medical Devices Rules 2017, covering device classification, registration, manufacturing, import, labeling, sales, and post- market requirements.

Three-Step Process for Medical Device Import License

...
Appoint an Indian
Authorized Agent
...
Appoint an Indian
Authorized Agent

Foreign manufacturers must appoint an Indian Authorized agent with a valid wholesale license to file their application with CDSCO. We streamline this process, ensuring a hassle-free experience.

...
Importer Registration
(Form MD-14, Form MD-15)
...
Importer Registration
(Form MD-14, Form MD-15)

Importers must register with CDSCO by submitting Form MD-14, required documents, and fees. Our team will guide you through this process for seamless business growth.

...
Test License to Import Medical
Devices (Form MD-16, Form
MD-17)
...
Test License to Import Medical
Devices (Form MD-16, Form
MD-17)

By completing Form MD-16, importers can import small quantities of medical devices for testing, demonstration, clinical investigations, or training. Our experts will help you obtain this test license efficiently.

Medical Device License: For Manufacturers

New Amendments
(Medical Devices 2020)

To get a CDSCO medical device manufacturing license, one must understand device classification under the new rules.

Class A & B
(Form MD-3, Form MD-5)

For Class A and B devices, contact the State Licensing Authority. Submit Form MD-3 with essential documents to receive Form MD-5.

Class C & D
(Form MD-7, Form MD-9)

For Class C and D devices, approach the Central Licensing Authority (CLA) and submit Form MD-7 to obtain Form MD-9.

Voluntary Registration
of Medical Devices

We simplify the voluntary registration process via an online portal,
ensuring compliance with the Medical Devices
(Amendment) Rules, 2020. Our platform ensures you follow the correct
procedures for FDA medical device registration.

Second Image First Image

Additional Permissions

Permission to Manufacture Class A & B Devices:

Manufacturers need to register under the Medical Device Rules 2017. We assist in completing forms and applications with state FDA authorities.

Permission to Manufacture Class C & D Devices:

For higher-risk devices, comply with CLA requirements. Our consultancy services ensure a smooth licensing process./p>

Permission for Test License (Form MD-12, Form MD-13):

For manufacturing small quantities for testing, training, or clinical investigation, submit Form MD-12. We help expedite the process to obtain Form MD-13.

Application for Clinical Investigation (Form MD-22, MD-23):

For clinical investigations, obtain permission from CLA by submitting Form MD-22. Our experts ensure accurate and hurdle-free application submission.

raise concern icon Raise a Concern?