How Israeli Medical Device Startups Can Navigate Complex Markets
Early next year, new regulatory changes will apply to medical equipment in EU /Europe, which will significantly impact the ability for Israeli companies to penetrate the European market. The new regulations aim to enhance patient safety, modernize public health, and set a benchmark for innovative, safe and reliable healthcare products.
Background
In May 2017, the EU Commission published new Regulations (EU) 2017/745 – also known as MDR – which follows the earlier European directive for Medical devices (93/42/EEC) – known as MDD – published in 1993. These new regulations apply three years (May 26, 2020) after entry into force of Regulation on medical devices and five years (May 26, 2022) after entry into force of Regulation on in-vitro diagnostic medical devices. The new regulations aim to reform the European Medical Device industry.
Note that existing devices that are CE marked under the current MDD must be recertified to abide by the new MDR. There is a clear guidance provided in MDR on when exactly a MDD based CE mark becomes void after 26th May 2020.
Impact of MDR
1. The Medical Device definition is broadened to include non-medical and cosmetic devices that were not regulated previously, and many devices are now considered Class III (higher risk class).
2. New changes require companies to justify their portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant.
3. General Safety and Performance Requirements define new conditions that must be addressed for CE marked devices.
4. Companies are required to update clinical data, technical documentation, labelling etc. and Unique Device Identification (UDI) is required on all labels to track devices throughout the supply chain.
5. Manufacturers must provide detailed clinical data from EU countries, and notify (on EU portal) about any incident, injury or death connected with the device, thereby empowering patients with access to safety information.
6. Manufacturers must provide detailed clinical data, and notify (on EUDAMED, the EU database portal) about any incident, injury or death connected with the device, thereby empowering patients with access to safety information.
Now what? Any clever options for Israeli start-ups?
After the US, most Israeli device manufacturers traditionally choose to focus on penetrating the EU market, as it is geographically close to Israel, the CE mark enables immediate sales in all CE countries, and most importantly, obtaining the CE mark was relatively straightforward and “easy.” Now, the new reforms are forcing Israeli companies to set their sights on new horizons.
New markets for consideration: Japan and India
Japan Over the last decade, imports of medical devices into Japan have increased by 50%.
Since 2014, Japan’s government has employed radical reforms to accelerate pre-market approval (Shonin) by the Pharmaceutical and Medical Device Agency (PDMA) for innovative technologies. Special fast-track status is awarded to devices that focus on the elderly (such as Regenerative Therapy etc.) and technologies that help reduce the hospitalization rate.
India
Another emerging market to consider is India, where the healthcare sector is booming and high-quality medical technology is increasingly in demand. India’s medical device market is the fourth largest market in Asia, having imported 75% of its medical devices since 2014. This market is expected to further increase as the Indian healthcare sector is growing at the rate of 17% and is expected to reach $250 billion by 2020. This explosive growth is a result of several factors including changing demographics and disease profile, increased spending ability, greater health awareness, medical tourism and foreign investment in private sectors.
What is my next step?
If you are an Israeli company that specializes in the development and manufacturing of medical technologies, in all medical fields – from cardiology and cancer, diagnostic systems to aesthetic medicine – don’t wait for the reforms to destroy what you’ve worked so hard to build. Contact a global expert in sales and business development for medical instrumentation and aesthetics industries to help you assess your options and determine your best path forward.
For more information please contact Oded Dotan at oded@oded-dotan.com.
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