Medical Device Registration in India (CDSCO)
Medical device regulatory consultants in India specialize in providing guidance and support to companies navigating the complex regulatory landscape for medical devices within the country. Navigating the regulatory process for medical devices in India can be complex, and consultants specializing in this field offer valuable expertise and guidance to streamline the approval process and ensure compliance with local regulations. Operon Strategist can provide expert solutions to comply with your products.
An Overview of Medical Device Registration in India (CDSCO):
Government Authority: CDSCO
Previously, entering the Indian medical device industry was a piece of cake because no approvals or certifications were required for medical equipment, but that situation has changed. Every country, including India, has its medical regulatory authority, known as the Central Drug Standard Control Organization (CDSCO).
Medical device registration in India is governed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare. If a manufacturer or a firm wants to set up medical device manufacturing in India, they must follow all the norms and regulatory procedures set by CDSCO.
At Operon Strategist, we are a team of skilled professionals that provides CDSCO medical device regulatory consulting services.
CDSCO MD Online Registration
MD online CDSCO registration is a platform provided by the Central Drugs Standard Control Organization (CDSCO) for the registration of pharmaceutical products, medical devices, and cosmetics. It enables manufacturers, importers, and distributors to apply for the necessary licenses and approvals required for the sale and distribution of their products in India. The online registration process is aimed at improving the efficiency and transparency of the regulatory system.
Classification of Medical Devices as per CDSCO:
MDR 2017 has categorized the devices as Class A, Class B, Class C, and Class D. Below table will spread some light on the classification of medical devices.
Type | Risk | Example |
Class-A | Low risk | Bandage, examination Gloves, etc. |
Class B | Low-Medium Risk | B.P. monitoring device, thermometer |
Class C | Moderate to High Risk | Implants, catheter |
Class D | High Risk | Heart Valve. |
Step-by-Step Process to Register your Medical Device in India with CDSCO
- Determine the Classification of your Medical Device: Determine your medical device’s regulatory classification using the Indian Medical Device Rules and applicable regulatory standards and classify your device based on the risk associated with its use.
- Prepare Technical Documentation: Compile the necessary technical documentation for your device’s registration. This may include device specifications, design and manufacturing information, labeling and packaging details, risk assessment, and performance testing data. Ensure compliance with the CDSCO’s requirements and guidelines.
- Appoint an Indian Authorized Agent: Select an authorized agent based in India who will act as your local representative for regulatory purposes. The authorized agent will coordinate with the CDSCO on your behalf and handle communication related to the device registration process.
- Submit the Application to CDSCO: Prepare the registration application in the prescribed format, including all required documents. This typically includes the application form, technical documentation, and proof of payment of fees.
- Review and Approval Process: CDSCO will review your application and evaluate the submitted documentation. They may request additional information or clarification during the review process. Cooperate with CDSCO and promptly respond to any queries or requests for further information.
- Inspection and Quality Management System Assessment: For certain high-risk devices, CDSCO may conduct an inspection of your manufacturing facility to assess compliance with quality management system requirements. Prepare for the inspection by ensuring adherence to Good Manufacturing Practices (GMP) and relevant international standards.
(Read about ISO 13485 Certifications) - Approval and Registration: The CDSCO will give registration approval for your medical device after a successful review and evaluation. You will be issued an official registration certificate stating that you have met all Indian regulatory requirements. The registration is normally valid for a set length of time, after which it must be renewed.
- Post-Market Surveillance: Compliance After obtaining registration, ensure ongoing compliance with post-market requirements, such as adverse event reporting, labeling updates, and product vigilance. Monitor and report any adverse events or safety concerns associated with your device as per CDSCO guidelines.
Navigating the medical device registration process in India can be complex. Partnering with a knowledgeable regulatory consultant can streamline the process and ensure compliance with CDSCO requirements. Their expertise and guidance will help you navigate the regulatory landscape and successfully register your medical device in India.
Medical Device Registration for Import License
Medical devices entering India must comply with the CDSCO’s Indian medical device regulations for registration. The CDSCO is in charge of approving and regulating new pharmaceuticals and clinical trials in the country, establishing drug standards, monitoring the quality of imported drugs, and coordinating the work of state drug control organizations.
Operon Strategist works with medical device distributors and wholesalers in the United States to obtain CDSCO import licenses.
Application Process to Grant Indian Import License:
For medical device imports into India from the United States, an import license is issued. The documentation for the medical device and production unit must be submitted jointly by the international company and the Indian company. In summary, the procedure is as follows:
Appointment of an authorized agent with a license to sell or distribute in India, who is entitled to apply for an import license.
Documents must be submitted with the application.
After reviewing the papers and the application in light of the inspection report, if the Central Licensing Authority’s inspection can be satisfied, grant the license in Form MD-15/26.
Exporting medical devices, The FDA issues export certification and charges a fee for it. The export certification is a document that contains information about the regulatory and marketing status of a product in the United States.
Operon Strategist's Role in Medical Device Registration in India (CDSCO)?
CDSCO registration process may look simple and easy but the reality is that one needs an expert regulatory consultant to complete this registration process. As a CDSCO registration consultant, we make sure that the clients will get error-free results within the timeframe. Also, We provide regulatory assistance to our clients for importing and exporting medical devices from the USA.
By offering categorization evaluation, document preparation, and timely filing of registration applications, our skilled team aids clients in navigating the complicated regulatory landscape. We also respond to CDSCO information requests and assist with the import and export of medical devices. Operon Strategist facilitates a smooth and effective CDSCO registration procedure for our clients through our knowledge and devotion to error-free results.
Contact us right away if you need dependable regulatory support in India.