A CDSCO Import License is mandatory for importing medical devices, cosmetics, and pharmaceutical products into India. Issued by the Central Drugs Standard Control Organization, this license ensures that imported products meet safety, efficacy, and quality standards. The process involves filing Form 10 or Form MD-14, submitting technical dossiers, and obtaining approval from the licensing...
Importing medical devices into India requires strict adherence to regulatory guidelines to ensure the safety, quality, and efficacy of healthcare products. The Central Drugs Standard Control Organization (CDSCO) regulates the import of medical devices under the Drugs and Cosmetics Act, 1940. Any foreign manufacturer or Indian importer planning to bring medical devices into India must...
Medical Device Trials are a critical component of advancing healthcare innovation, ensuring that new technologies are safe, effective, and compliant with regulatory standards before reaching patients. Unlike pharmaceutical studies, Medical Device Trials focus heavily on device performance, usability, and real-world application, often requiring adaptive designs and close collaboration between...
Ultrasonic welding is a critical technique in medical device manufacturing, especially when working with polymers like polypropylene (PP). PP ultrasonic welding offers a high-speed, precise, and clean method of joining materials. However, despite its advantages, there are various challenges associated with using this technology in medical device production. This article explores those...
In the ever - evolving landscape of healthcare, medical devices play a pivotal role in diagnosing, treating, and preventing diseases. The research and development (R&D) process behind these life - saving and life - enhancing tools is a carefully orchestrated symphony of innovation, science, and engineering. Unveiling the secrets of the medical device R&D process provides valuable...
A laser removal device is an advanced medical or cosmetic machine that uses concentrated laser light to safely and effectively remove unwanted elements from the skin or body. These devices are commonly used for procedures such as tattoo removal, hair removal, scar reduction, pigmentation correction, and vascular lesion treatments. By targeting specific pigments or tissues without harming the...
In today’s fast-moving Indian market, compliance with regulatory standards is not just a legal requirement — it is a foundation for trust, safety, and success. For manufacturers and importers in sectors like cosmetics and medical devices, the Central Drugs Standard Control Organization (CDSCO) plays a central role in ensuring product safety and quality. This blog explains CDSCO...
In 2025, India’s healthcare infrastructure continues to evolve rapidly, with a growing dependence on critical medical devices such as ventilators, diagnostic kits, infusion pumps, and surgical instruments. With rising healthcare demands and a heightened focus on quality and patient safety, the Indian government has strengthened its regulatory framework to ensure that only safe, effective,...
If you are planning to enter the Indian market with products like medical devices, cosmetics, or drugs, one name you will hear again and again is CDSCO. Many businesses feel confused or even scared when they hear about CDSCO licensing because the process looks complex at first glance.
But the truth is, once you understand the basics, CDSCO licensing becomes much easier to manage.
In this...
India’s pharmaceutical and MedTech industries have grown exponentially over the past two decades, positioning themselves as key global players. The country is now recognized as the “Pharmacy of the World,” supplying over 50% of global vaccine demand, 40% of generic drugs in the U.S., and a significant share of active pharmaceutical ingredients (APIs) worldwide. Alongside, the...
Lean manufacturing focuses on maximizing efficiency, reducing waste, and creating value for the customer. While the system emphasizes tools and methodologies such as Kaizen, 5S, and Just-In-Time, its true strength lies in the people who drive these processes. Human resources play a critical role in building, maintaining, and sustaining a lean manufacturing culture. Recruiting a skilled and...
If you are involved in the healthcare or pharmaceutical business in India, you must have heard of CDSCO. CDSCO stands for the Central Drugs Standard Control Organization. It is the main authority in India that looks after the approval and regulation of drugs, cosmetics, and medical devices. In simple words, CDSCO makes sure that the medicines and products people use are safe, effective, and of...
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