Medical Device/ivd (CDSCO)
At Iqzyme MedTech, we specialize in providing comprehensive regulatory services for medical devices and in vitro diagnostics (IVD) under the strict guidelines of the Central Drugs Standard Control Organization (CDSCO). As a trusted partner for medical device manufacturers, importers, and distributors, we offer expert guidance through the regulatory pathways to ensure that your products meet Indian compliance standards and reach the market efficiently. From acquiring necessary licenses to ensuring compliance with quality and safety regulations, our goal is to help you navigate the intricate processes involved in bringing medical devices and IVDs to life.
One of the primary services we offer is assistance with obtaining a Medical Device / IVD Manufacturing License (CDSCO). Manufacturing medical devices in India requires adherence to strict regulatory guidelines as outlined by CDSCO under the Medical Device Rules, 2017. We provide end-to-end consultation to help you prepare the required documentation, comply with quality management systems, and ensure your facility meets the regulatory requirements for manufacturing.
For companies looking to conduct clinical trials or performance evaluations, we provide support for acquiring a Medical Device / IVD Test License (CDSCO). This license allows manufacturers to test their devices in a controlled environment, ensuring that they meet the safety and performance standards necessary for commercialization. Our team ensures that your application process is smooth and that all necessary data and test results are prepared for submission to CDSCO.
If you are importing medical devices or IVDs into India, a Medical Device / IVD Import License (CDSCO) is mandatory. This license ensures that all imported devices meet the required safety and efficacy standards before they are allowed in the Indian market. We assist you in obtaining the necessary clearances for importing medical devices and IVDs, ensuring that you are fully compliant with the Indian regulatory framework.
In addition to manufacturing and import licenses, we also facilitate the application process for a Medical Device / IVD Loan License (CDSCO). This license allows manufacturers to produce devices in a third-party facility without owning the manufacturing unit themselves. This can be a cost-effective solution for companies looking to expand their production capabilities without investing in their own manufacturing infrastructure.
For those in the business of distributing medical devices and IVDs, we offer assistance in securing a Medical Device / IVD Wholesale & Retail License (CDSCO). Whether you're operating as a wholesaler or a retailer, this license is essential for ensuring that your distribution activities comply with the regulatory standards laid out by CDSCO. We help you navigate the application process, ensuring all necessary documentation is in place for regulatory approval.
At Iqzyme MedTech, we understand that the regulatory landscape can be complex and ever-changing. That’s why we provide personalized consultation services tailored to the unique needs of your business. Our team of experts is equipped with in-depth knowledge of CDSCO regulations and the Medical Device Rules, 2017, ensuring that your company stays compliant at every stage of the process. Whether you're a start-up seeking your first license or an established manufacturer looking to expand into new markets, we offer the support and guidance you need to succeed.
Our commitment to excellence and adherence to Indian regulatory standards ensures that you can bring safe, effective, and high-quality medical devices and IVDs to market efficiently. With our expertise in regulatory affairs and a deep understanding of CDSCO processes, Iqzyme MedTech is your partner in achieving compliance and ensuring the successful launch of your medical device or IVD in India.