India is a lucrative market for medical devices business. Indian medical devices industry, one of the top 20 markets in the world, is the 4th largest market in Asia. The Indian government is aimed at establishing India as a hub for manufacturing affordable, high-quality, and innovative medical devices. Starting a medical device business in India has certain regulatory requirements. CDSCO medical devices registration is mandatory to manufacture, sell, and distribute medical devices in India. The process is complicated and difficult to navigate. It is important to have a trusted consultant who can help you with your medical device registration needs. This blog provides an outline of the medical device registration process and requirements.

CDSCO medical devices registration guide and tips

• 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.
• Preparation of documents: Various supporting documents need to be prepared for CDSCO medical devices registration. CDSCO requires the documents to be written in English. The documents should be arranged per the order specified by CDSCO.
• Applying on the CDSCO portal: The application along with the necessary supporting document need to be prepared. The application and the CDSCO medical device registration fees need to be submitted online to the CDSCO portal. Then, the CDSCO will review the registration application. If necessary, CDSCO may request additional clarification or information. All CDSCO queries need to be responded to.
• CDSCO inspection and review: The CDSCO regulatory body will inspect the medical device manufacturing facility to ensure the facility meets the quality and safety standards. The regulatory body will evaluate whether the medical device is safe and effective. During the review process, CDSCO will analyse all relevant data, conduct site inspections, and consult experts in the relevant field.
• CDSCO approval or rejection: The CDSCO may approve the medical device for sale and distribution in India, if the product meets the required safety and efficacy standards.

Obtaining a CDSCO license for medical devices registration in India is a cumbersome and lengthy process. 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. We have over 27 years of experience in licensing and documentation for the registration of medical devices in India. Our expertise can help you easily launch and grow your medical devices business in India.

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 has 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.

Content of the device master file typically includes:

• Executive summary
• Device description and product specification
• Labeling
• Design and manufacturing information
• Essential principles checklist
• Risk analysis and control summary
• Verification and validation of 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.

Content of the plant master file typically includes:

• General information
• Personnel information
• Premises and facilities
• Equipment
• Sanitation
• Production
•  Quality assurance
• Storage
• Documentation
• Medical device complaints and field safety corrective action
• Internal audit
• Contract activities

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 prepare you for the audit performed by the regulatory body prior to certification. Our mock audit service can help you identify any lapse in 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. The guidance and support of an experienced consultant can make the registration of medical devices a cake walk. Pharmadocx Consultants can help you navigate through the complex registration process for medical devices in India. Call/Whatsapp us at 9996859227 or drop an email at [email protected] to get support and tips for medical devices registration.