Blog

As India moves toward stronger evidence-driven medical device regulation, manufacturers often assume that an India-specific clinical investigation is mandatory for every new import or registration. Under MDR 2017 and the subsequent guidance updates, this is not always true. In fact, CDSCO increasingly accepts Real-World Evidence (RWE) as a valid form of clinical validation if the […]

Global medical device manufacturers expanding into India often ask a common question: “Can we reuse our FDA or CE evidence for CDSCO registration?”The short answer: Yes, if the data is mapped, justified, and repurposed correctly. India’s regulatory framework under the CDSCO Medical Device Rules, 2017 (MDR 2017) strongly emphasises safety, performance, and clinical evaluation. This

Medical device approvals in India under the Medical Device Rules (MDR) 2017 have become more structured and predictable, but delays still occur frequently. While standard CDSCO timelines range from four to nine months depending on device class and dossier complexity, many applications experience setbacks of one to three months due to avoidable mistakes in documentation,

India’s medical device ecosystem is undergoing one of its fastest periods of regulatory growth, and the clearest indicator is the sharp rise in Class A and Class B registrations across therapeutic categories. As 2025 unfolds, this trend is expected to accelerate even further, driven by a mix of regulatory reforms, increased market demand, and the

Introduction ASEAN continues to take major steps toward regional regulatory convergence in medical devices, with Malaysia emerging as a driving force behind innovative reliance models. Following the successful Malaysia–China Regulatory Reliance Programme, Malaysia and Singapore have now launched a joint pilot to fast-track medical device registrations across both nations. These bilateral frameworks are designed to

Introduction Malaysia has rapidly emerged as one of ASEAN’s key medical device markets, driven by growing healthcare infrastructure, increasing demand for innovative devices, and a regulatory system aligned with international standards.For manufacturers and regulatory professionals aiming to enter this market, understanding the Medical Device Conformity Assessment process is essential. This process, governed by the Medical