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The Indian medical devices market: a growing opportunity
Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region....
When and how to report a medical device product fault to EU regulators
Do I need to report a medical device product fault to EU regulators? All products, including medical devices, are not immune to faults and failures. Unfortunately, an undetected manufacturing defect, an error in the use of the product, or other safety problems...
CE Marking Changes in the UK: highlights and pointers for MedDev manufacturers
On the 1st August 2023, the UK Government announced that they intend to continue to recognise CE marking across England, Wales and Scotland, indefinitely, for most goods beyond December 2024[1]. The CE marking has long been a symbol of compliance with essential...
The Power of Partnerships
At this time of year, Expo Season gives way to holidays. In the madness of following up all the exciting innovators and new strategic partners I met on my recent travels, all bursting with the potential of better patient care and commercial success, at least my aching...
Deep Dive in the Asia Pacific Medical Device Market – China
Welcome back to our articles dedicated to emerging market access. This time we will explore Asia Pacific a bit further. This is the fastest-growing region in the global medical devices market valued at over $105 billion (USD) in 2022! We already looked at market...
Post Market Clinical Follow up, what is this and what do I need to do?
Over the last few years there has been an increasing focus from medical device regulators on demonstrating continuing performance and safety of products after their initial product approval. Particularly in the European Union and following the EU MDR 2017/745...
Expanding into LATAM for medical device manufacturers
This is the third short article in a 3-part series written by IMed’s own Daniel English. Following on from with part 2 with part 3 in this global expansion review we look in the Latin America region. This short article will provide an overview of those classification...
Medical device product fault reporting the to the US FDA
Do I need to report a medical device product fault to the US FDA? In the unfortunate event that an undetected manufacturing defect is found in a medical device, or there is an error in the use of the product, or other safety problems are encountered during the...
EU Post Market Surveillance – Transitional Requirements for Medical Device Manufacturers
The transition of the medical device industry in the European Union to the Medical Device Regulations 2017/745 is now well underway. Thousands of manufacturers are now successfully certified to the new regulation, and more certifications are being issued each week....