CDSCO Medical Device Registration
Our CDSCO medical device registration service simplifies your entry into the Indian market with innovative medical devices. Say farewell to complex procedures and embark on a hassle-free path to success for your products.
Secure Your Drug License with GeMTech PARAS!
Your expert in drug regulatory consulting. We specialize in a wide range of licenses, including import and registration of drugs, permissions for new drugs, investigational new drugs, Subsequent New Drugs, manufacturing licenses, and more. We navigate the regulatory landscape with precision and deep expertise.
Pave Your Way to Success with GeMTech PARAS!
Easily navigate the complexities of In Vitro Diagnostic licensing. Rely on our expertise for thorough regulatory guidance and compliance. Begin your success story with our insightful and strategic support.
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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.
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
Registraion Certificate
Under Rule 27A, foreign manufacturers can obtain a “Registration Certificate” issued in Form 41 by the licensing authority, allowing them to register their premises for drug import into India. The drug manufacturing facilities must be approved by the National Regulatory Authority (NRA) in the country of origin. Our experts will assist you in accurately completing Form 40 to secure your Registration Certificate.
Import License
A drug import license, issued in Form 10, is required for importing drugs. For drugs listed in Schedule X, a Form 10-A License is necessary. Applications for importing drugs (excluding Schedule X) must be made using Form 8. For Schedule X drugs, Form 8A is required. Import licenses can be applied for by foreign manufacturers with a valid wholesale license or their agents in India.
New Drugs Approval
The New Drugs and Clinical Trial Rules, 2019, introduced by the Government of India on March 19, 2019, set specific requirements for conducting clinical trials, approving new drugs and investigational new drugs, registering BA/BE centers, and ethics committees. Companies must follow these guidelines and submit their documents to the Central Licensing Authority (CLA)....
Subsequent New Drug
A subsequent new drug, as defined by CDSCO, refers to a drug already approved by the CLA but proposed to be marketed with modified or new claims, such as new indications, routes of administration, dosages, or dosage forms. Our platform offers effective assistance in submitting applications for subsequent new drug licenses. ...
Fixed Dose Combination (FDC)
Fixed Dose Combinations (FDCs) involve combining two or more active drugs into a single dosage form. CDSCO categorizes FDCs into four groups: 1. FDCs where one or more active ingredients are new drugs. 2. FDCs where active ingredients are combined for the first time for a specific claim. 3. FDCs not marketed anywhere but using drugs already in use individually. Read More.
Test License
An importer needs a license in Form CT-16 to import small quantities of otherwise prohibited drugs for clinical trials, bioavailability or bioequivalence studies, or examination, testing, or analysis. Our team helps navigate the rules under the New Drugs and Clinical Trials Rules 2019 to obtain a Test License.
Clinical Trials
Clinical trials systematically study new drugs in human subjects to gather data on their safety, efficacy, pharmacodynamics, pharmacokinetics, and adverse effects. Our professionals guide you through the rules and guidelines for obtaining a license to conduct clinical trials in India.
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.
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.
