UDI Submission for China NMPA
Although the regulatory process can be challenging due to rapid changes, bringing medical devices to the Chinese market is a potential high-growth area for many global manufacturers. So, if you’re a medical device manufacturer doing business in China, it’s important...
EU-MDR Date of Application – Postponed…
The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the 4 technical amendments proposed last week by the European Council, without bringing additional...
Medical Device Manufacturing and COVID-19: Challenges and Opportunities
Medical Device Manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic, with many experiencing an adverse impact on their supply chain and operations, their financial expectations and emergency response plans. The need...