India’s DCGI, on January 6 revised the device classification of 4 main device categories. These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More
The Drug Controller General of India (DCGI) has already issued a regulation outlining the need for makers, importers, and sellers of drugs, to report adverse events. However, on November 11, to enhance overall supervision, India issued a new pharmacovigilance document to major... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
India’s Drugs Controller General of India (DCGI) has implemented new measures to reinforce the monitoring of medical device related adverse events. This initiative is part of the Materiovigilance Programme of India (MvPI), managed by the Indian Pharmacopoeia Commission (IPC), which is in charge of collecting and analyzing... Read More
The Delhi High Court has passed landmark orders for the Indian government regarding rare disease treatment, focusing on funding, regulatory reforms, and price controls. The court has ordered the establishment of a National Fund for Rare Diseases (NFRD), with an initial allocation over... Read More
In early September, India’s Department of Pharmaceuticals has requested that there is a new code set up for marketing and advertising medical devices in-country. The new regulation is titled – Uniform Code for Marketing Practices in Medical Devices (UCMPMD). Prior to this... Read More
The Indian government is unveiling a risk-based framework that governs the quality of imported medical devices into the country to improve safety standards. Randomized sampling will be required for the vast majority of imported medical devices, and only high-priority and diagnostic kits... Read More
The Indian drug business is a huge business estimated at about $67 billion per year. Many Western drug companies rely on Indian APIs, excipients, and final drug products. Last December, the Health Ministry required all Indian drug companies to meet Indian GMP... Read More
In early August, India’s Central Drug Standard Control Organisation (CDSCO) decided to eliminate the need for local Indian clinical trials for certain drugs if they have already been approved in the EU, US, UK, Australia, Japan, and Canada. This new regulation and new... Read More
On July 18, the Japanese Ministry of Health, Labor and Welfare (MHLW) introduced new criteria for excluding certain drugs from mandatory post-marketing surveillance (PMS), traditionally required for newly approved medicines. This initiative aims to mitigate delays and reduce losses in drug availability. The MHLW informed... Read More