MD-42 license India requirements are a key concern for anyone involved in the medical device supply chain, especially as India’s healthcare market expands rapidly. The MD-42 Registration Certificate, introduced under the Medical Devices Rules, 2017, and reinforced by the Fifth Amendment (G.S.R. 754(E) dated September 30, 2022), is mandatory for entities handling the sale, stocking, […]
The MD-41 application is the official form used to apply for a registration certificate (issued as Form MD-42) to sell, stock, exhibit, offer for sale, or distribute medical devices—including in-vitro diagnostic (IVD) devices—under the Medical Devices Rules, 2017 (as amended). This is mandatory for wholesalers, retailers, distributors, stockists, pharmacies, hospitals, and diagnostic centers handling medical
The MD-42 license (also referred to as Form MD-42 or MD 42 registration certificate) is a mandatory regulatory authorization in India for entities involved in the sale, stocking, exhibition, offering for sale, or distribution of medical devices, including in-vitro diagnostic (IVD) devices. Issued under the Medical Devices Rules, 2017 (as amended by the Fifth Amendment
What Is the MD-42 License? Read More »
Software as a Medical Device (SaMD) refers to standalone software intended to be used for one or more medical purposes (e.g., diagnosis, screening, monitoring, mitigation, treatment, or alleviation of disease) without being part of a hardware medical device. This includes mobile apps, AI/ML-based diagnostic tools, cloud-based imaging analysis software, clinical decision support systems, and other
FDA Regulations for Software as a Medical Device (SaMD) in the United States Read More »
Software as a Medical Device (SaMD) refers to standalone software intended to perform one or more medical purposes (e.g., diagnosis, monitoring, prediction, prevention, or treatment of disease) without being part of or embedded in a hardware medical device. This includes mobile apps, AI/ML-based diagnostic tools, cloud-based imaging analysis software, and other digital health solutions running
CDSCO Regulations for Software as a Medical Device (SaMD) in India Read More »
Manufacture Novel Medical Devices – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the prescribed application form submitted to the Central Licensing Authority (CLA) within the Central Drugs Standard Control Organisation (CDSCO). It is used to seek prior permission for importing or manufacturing a novel (new or investigational) medical device that does
MD-26 Explained – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the official application form submitted to the Central Licensing Authority (CLA) of the Central Drugs Standard Control Organisation (CDSCO) when seeking permission to import or manufacture a novel medical device (also called an investigational medical device or new medical device). A
Importing medical devices into India for manufacturing, assembly, or further processing requires a CDSCO Import License (Form MD-15), even if the goal is local production. Under the Medical Devices Rules, 2017 (with 2025–2026 updates on perpetual validity, retention fees, and streamlined submissions), foreign manufacturers must appoint an Indian Authorized Agent to apply via the SUGAM
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s independent regulator for medicines, medical devices, blood components, and related products. Post-Brexit, the MHRA operates a distinct UK framework (separate from the EU/EMA), focusing on Great Britain (England, Wales, Scotland) and Northern Ireland (with some EU alignment via the Windsor Framework). The MHRA emphasizes
MHRA Approval Process: Overview for Medicines and Medical Devices in the UK (2026) Read More »
The European Medicines Agency (EMA) is the centralized regulatory body for the European Union (EU), responsible for evaluating and recommending approvals for human medicines across 27 EU member states plus Iceland, Liechtenstein, and Norway (EEA). EMA’s process focuses on harmonized evaluation, but final marketing authorization comes from the European Commission (EC), adding a step not
EMA Drug Approvals: Key Process, Timelines & Comparison to FDA Read More »
