Key Takeaways – CDSCO Manufacturer License for Oximeters: MD-7 & MD-9 Introduction If you are setting up an oximeter manufacturing business in India and your device falls under Class C — or if you are looking to produce oximeters through a Loan License arrangement — you are dealing with two [...]
Introduction If you are planning to import oximeters into India, you cannot skip the CDSCO Import License. The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body that governs the import of medical devices, including pulse oximeters, under the Medical Devices Rules, 2017. Without this license, your consignment [...]
Introduction If you’re in the business of importing drugs, cosmetics, or medical devices into India, you have probably come across the terms COS-1 and COS-2. And honestly, the confusion is understandable — both sound like certificates, both are part of the CDSCO registration process, and both are absolutely non-negotiable if [...]
Introduction So you want to import cosmetics into India — great market, massive opportunity. But before a single unit clears customs, you need to answer one very specific question: does your product need a CDSCO cosmetic import license? The answer depends entirely on what the product is, what it contains, [...]
Introduction If you are a brand manager, an importer, or a regulatory consultant trying to bring foreign cosmetic products into India, you already know the process is not simple. The regulatory framework is strict, the paperwork is detailed, and one wrong step can mean months of delay or outright rejection [...]
Introduction If you are setting up a Medical Device distribution business, a hospital equipment supply company, or a wholesale depot for surgical instruments in Delhi, you already know the compliance landscape has tightened considerably since the Medical Devices Rules 2017 came into effect. Gone are the days when medical devices [...]
Introduction If you want to legally buy medical devices in bulk and sell them to retailers, hospitals, or other distributors anywhere in India, you need a Medical Device Wholesale License — commonly referred to by professionals as the MD-41 or MD-42 license. This is not just a formality. Operating without [...]
Introduction If you are an importer of In-Vitro Diagnostic Devices — ranging from blood glucose meters and pregnancy test kits to PCR diagnostics and HIV screening assays — you already know that India is one of the fastest-growing diagnostic markets in the world. But with that growth comes a very [...]
Introduction If you are planning to import medical devices into India, you have probably come across the term Form MD-14 at some point. And if you are confused about what it actually is, what it covers, and how to apply for it, you are not alone. Many importers, distributors, and [...]
Introduction If you are planning to import medical devices into India, there is one regulatory step you simply cannot skip — obtaining your MD-14 and MD-15 import license from CDSCO. It does not matter whether you are a multinational medical device company entering the Indian market for the first time [...]
