Medical Device Registration


Terz Compliance's Expert Assistance

Are you a medical device manufacturer looking to enter the dynamic Indian market? Terz Compliance specializes in providing manufacturers with seamless and transparent assistance in the process of registering medical devices in India.

Whether you're an established manufacturer seeking expansion or a newcomer eager to explore India's market potential, Terz Compliance is your reliable, transparent, and cost-effective partner. We simplify the regulatory process, allowing you to make a positive impact with your medical devices in India.

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Our Comprehensive Services:

  • Expert Guidance: Our team of regulatory experts simplifies the complex regulatory landscape set by the Central Drugs Standard Control Organization (CDSCO). We provide clear guidance on product classification, documentation, and quality standards without using technical jargon.
  • Efficient Registration: Terz Compliance is committed to ensuring a smooth and timely registration process for your medical devices. We handle the regulatory intricacies, allowing you to focus on bringing your products to market confidently.
  • Quality Assurance: Meeting quality standards is vital when entering the Indian market. Terz Compliance works closely with manufacturers to ensure that their medical devices meet the strict criteria outlined by ISO 13485 and other applicable regulations.
  • Prompt Licensing: Our commitment to efficiency ensures that you receive the necessary licenses and approvals on time. We understand the importance of meeting deadlines and work diligently to expedite the licensing process.
  • Transparency: At Terz Compliance, we prioritize transparency throughout the registration process. We keep you informed at every step, providing a clear understanding of the progress and requirements, ensuring that you are always in the loop.
  • Real-time Updates: Our clients benefit from regular, real-time updates on the status of their registration process. You can track the progress of your application, enabling you to plan accordingly and make informed decisions.
  • Cost-Effective Solutions: Terz Compliance offers cost-effective services, helping you navigate the Indian regulatory landscape without breaking the bank. We understand the value of cost efficiency and strive to provide economical solutions.

Process of registration of Medical device

The process of registering a medical device in India can be complex and involves several steps. Here is a simplified overview of the typical registration process:

  • Determine Device Classification: The first step is to determine the classification of your medical device according to the Indian regulatory framework. Devices are classified into different categories based on their risk and intended use.
  • Appoint an Indian Agent: Foreign manufacturers are required to appoint an authorized Indian agent who will represent them before the Indian regulatory authorities.
  • Prepare Documentation: Prepare a comprehensive set of documents, including:
    • Device technical specifications and labeling
    • Risk assessment report
    • Clinical data (if applicable)
    • Quality management system certification (e.g., ISO 13485)
    • Declaration of conformity
  • Submit Application: Submit your registration application along with the required documents to the Central Drugs Standard Control Organization (CDSCO). The application should be submitted through the Online System for Medical Devices (OSMD).
  • Review and Evaluation: The CDSCO will review your application and documents. This may involve a thorough examination of your device's technical data and safety information.
  • Clinical Trials (if necessary): Depending on the risk classification of your device, clinical trials may be required to establish safety and efficacy. This step is not applicable to all devices.
  • Inspection of Manufacturing Site: The CDSCO may conduct an inspection of the manufacturing facility to ensure compliance with quality standards.
  • Registration Certificate: If your application is approved, you will receive a Registration Certificate from the CDSCO. This certificate allows you to legally market and sell your medical device in India.
  • Post-Market Surveillance: After registration, it's essential to establish a post-market surveillance system to monitor the safety and performance of your device and promptly report any adverse events.
  • Renewal and Compliance: Medical device registrations typically need to be renewed periodically. Ensure ongoing compliance with evolving regulations and standards.

Please note that the specifics of the registration process may vary depending on the device's classification and other factors. It is crucial to consult with regulatory experts or a consultancy like Terz Compliance for precise guidance tailored to your device and regulatory requirements. Additionally, regulations and processes may change over time, so staying updated with the latest information from the CDSCO is essential.

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For importing medical devices following is the process followed:
Importing medical devices into India involves a regulatory process to ensure that products meet safety and quality standards. Here is an overview of the typical process for medical device importers in India:

All the process will be followed according to the Medical Devices Rules, 2017 under Drugs and Cosmetics Act, 1940. Requisite fees will be as per the Second Schedule of MDR, 2017.

Please note that the specific import process may vary depending on the device's classification and other factors. It's crucial for importers to work closely with regulatory experts or consultancies like Terz Compliance to ensure compliance with the latest regulations and navigate the import process effectively. Additionally, regulations and processes may change over time, so staying updated with the latest information from the CDSCO is essential.

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