CDSCO Medical Devices Registration in India
CDSCO medical devices license and registration in India
Obtaining a CDSCO license for medical devices registration in India is a cumbersome and lengthy process. Moreover, various supporting documents and expertise in the CDSCO application process are required.
The Pharmadocx Consultants team can make the medical devices registration process seamless for you.
Basic CDSCO medical devices registration steps
1. Medical device classification:
The first step in the medical device registration process is classification of the device based on CDSCO regulatory guidelines.
The medical device needs to be categorized into one of the four risk classes depending on its intended use and associated risks.
2. Preparing documents:
Various supporting documents need to be prepared for CDSCO medical devices registration.
3. Applying on the CDSCO portal:
The application along with the necessary supporting document need to be submitted online to the CDSCO portal. Additionally, the CDSCO medical device registration fees need to be paid online.
4. CDSCO review and inspection:
Then, the CDSCO will review the registration application and verify the documents. Furthermore, if required, CDSCO may request additional clarification or information. All CDSCO queries need to be responded to. If required, the CDSCO regulatory body will inspect the medical device manufacturing facility to ensure it meets the quality standards.
5. CDSCO medical device license approval:
The CDSCO may approve the medical device for sale and distribution in India, if the product meets the required safety and efficacy standards.
Thus, navigating the medical device registration process in India is not easy.
Common documents required to register medical devices in India
- A covering letter providing a brief overview of the submission.
- The application form with all the fields filled in as per requirement.
- Free sale certificate from the country of origin may be required. This is required to certify the product is freely sold and legally marketed in its country of origin.
- Inspection or audit report
- For foreign manufacturers, a power of attorney may be required. A power of attorney document will authorize an agent to act on behalf of the manufacturer during the registration process.
- A device master file providing detailed technical information on the medical device.
- Plant master file
- Manufacturing site or establishment registration copy
- A risk assessment report presenting potential risks associated with the medical device. It should also ideally highlight risk mitigation strategies.
- If the medical device belongs to certain categories, such as high-risk devices, a clinical evaluation report may be required. This report should outline the safety and efficacy of the product.
- ISO 13485 certificate
- CE certificate
- CE design certificate
- Declaration of conformity
This list provides an overview of the documents required to obtain a CDSCO medical device license. For a detailed list of documents required, feel free to get in touch with us.
How can Pharmadocx Consultants help you with the CDSCO medical devices registration and license process?
We at Pharmadocx Consultants provide various services for CDSCO medical devices registration. Our services broadly include CDSCO medical devices manufacturing license, CDSCO medical devices test license, and CDSCO medical devices import license.
We not only help with license application but also provide CDSCO registration documentation preparation assistance. Our documentation services include assistance with preparation of device and plant master files, SOPs, essential principle checklists, and risk management.
The Pharmadocx Consultants team provides the following services for licensing and registration of medical devices of all categories:
License application
Depending on the risk level and whether you are applying for import/manufacture/wholesale of the medical device, CDSCO grants different licenses. We can help you with the application of the following categories of medical device licenses: MD3, MD4, MD5, MD6, MD7, MD8, MD9, MD10, MD12, MD13, MD14, and MD15.
Being a CDSCO medical device license application expert, we will ensure the CDSCO medical devices registration process is hassle free. We will help file online application for license to import and manufacture medical devices of all CDSCO risk classes. Armed with the knowledge of the registration requirements, we will make the CDSCO registration for medical devices seamless for you.
Furthermore, CDSCO may raise queries during the license application process, which need to be responded in a timely manner. We are committed to make the CDSCO medical device registration process hassle free. Hence, we will provide guidance for responding to these queries.
Authorized agent service
Foreign companies planning to enter the Indian medical devices market will need an authorized agent for registration of medical devices. Understanding the local requirements and regulations for medical devices registration can be difficult.
As an authorized agent, we assist foreign companies aiming to enter the Indian medical devices market. The Pharmadocx Consultants team has valid IEC Code, SIO 13485, and CDSCO MD42 licenses. These licenses enable selling and distribution of medical products and services. Additionally, we have the expertise to file applications with the Central Licensing Authority for Medical Device registration. Our specialization is simplifying the complex process of registration and licensing of a medical devices business in India.
Device master file
The device master file is a vital component of the documents required for CDSCO medical device license application. The device master file provides detailed information on the medical device. This a technical document indicating the compliance of the medical device with the international standards and local standards. The device master file includes the history of the medical device along with stages of development and design. This is used by the regulatory body to evaluate the medical device.
Preparing the device master file is cumbersome and has extensive requirements. The Pharmadocx Consultants team will help you craft the device master file as per Schedule IV of the medical device rules, 2017. The device master files prepared by us will be in accordance with the requirements of both Medical Device Rules, 2017, and ISO 13485.
Plant master file
The plant master file is another vital component of the documents required for CDSCO medical device license application. The plant master file provides detailed information on the medical device manufacturing facility. The regulatory body uses this file to assess whether the facility abides by the requirements of Medical Device Rules, 2017, and other international standards.
Owing to the extensive requirements, preparation of the plant master file requires a certain level of expertise. The plant master file is one of the basic requirements for obtaining CDSCO medical device license. One of the expertise of the Pharmadocx Consultants team is preparation of the plant master file. We will help prepare the plant master file as per the Schedule IV of the Medical Device Rules, 2017.
Medical device manufacturing license audit
The CDSCO regulatory body performs an audit prior to granting the CDSCO medical device manufacturing license. Extensive preparation is required for this audit.
Armed with years of experience, the Pharmadocx Consultants team is specially placed to prepare you for this audit. Our team will help prepare the required documents. Also, we will conduct a mock audit to prepare you for the actual audit performed by the officials.
ISO 13485:2016 and ICMED Certificate
ISO 13485:2016 and ICMED certification is essential for marketing your products.
We at Pharmadocx Consultants provide support for obtaining the ISO 13485:2016 and ICMED Certificate. We can help you prepare the necessary documents. Additionally, we prep you for the audit performed by the regulatory body prior to certification. Our mock audit service can help you identify any lapse in the compliance with the required benchmark.
Layout designing
Medical device manufacturing facilities have to be designed as per regulatory guidelines for obtaining the medical device manufacturing license. The facilities have to comply with Medical Device Rules, 2017, and ISO 13485.
The Pharmadocx Consultants team is adept at designing manufacturing units per regulatory and good manufacturing practices requirements. Our experience includes providing design consultation to over 200 pharmaceutical units and 150 medical device units.
Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
Phone / Whatsapp
Address
- Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Delhi Office - G-12, Pearls Best Heights-I, Netaji Subhash Place, Delhi, 110034
Why should you register your medical device with CDSCO?
- CDSCO registration provides access to one of the largest medical device hubs in the world.
- CDSCO registration highlights the compliance of the manufacturer with Indian regulatory requirements, including Good Manufacturing Practice and Medical Device Regulation. It demonstrates the commitment of the manufacturer to deliver high quality medical devices.
- CDSCO registration is a necessary requirement for manufacturers to participate in tenders floated by government and private institutions. Thus, it provides a competitive advantage.
- CDSCO registration improves the credibility of the manufacturer. It provides brand recognition. Medical devices registered with CDSCO indicate that rigorous quality, safety, and efficacy standards have been met.
Pharmadocx Consultants your trusted ally for securing medical devices registration in India
With an in-depth understanding of the CDSCO regulations, Pharmadocx Consultants is dedicated to simplifying your path to securing registration and license for medical devices in India. We leverage our expertise and industry knowledge to help medical device manufacturers obtain medical device manufacturing, test, and import license.
Providing support for the entire CDSCO medical device registration journey
Our service does not end with assistance for registration application. We also provide license grant support, providing assistance till you secure your license. Our all-encompassing service ranges from license application and document preparation to procuring the CDSCO license. Our team of experts will help you respond to any query raised by the officials. We will monitor the application process till the license is granted.
Why choose Pharmadocx Consultants?
Medical Device Licences
Years Experience
Plants Set-up
Our Prestigious Clients
Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
Phone / Whatsapp
Address
- Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Delhi Office - G-12, Pearls Best Heights-I, Netaji Subhash Place, Delhi, 110034