India's Medical Devices Rules, 2017 (MDR 2017) has a distinct regulatory pathway for Devices classified as New Medical Devices — a category that carries additional scrutiny, documentation requirements, and in many cases,...

One of the most consequential decisions a Medical Device company faces when entering the Indian manufacturing landscape is whether to establish its own licensed manufacturing facility or to operate under a loan...

India's Medical Device manufacturing sector is growing rapidly, driven by a combination of government policy, the Make in India initiative, and increasing global demand for cost-effective, high-quality medical products. For any company...

For any Foreign Medical Device company seeking to sell its devices in India, obtaining an Import License from CDSCO is a mandatory Regulatory requirement. The two central application forms in this process...

For foreign Medical Device companies entering India, the authorized agent is not just a compliance checkpoint — it is a strategic regulatory role. The right appointment can support licensing procedure, smoother filings,...