TAIPEI, Dec. 5, 2018 /PRNewswire/ — The continued growth of the global medical device industry means requisite safety testing and certification for medical devices that can be quite challenging before they are released to market. On November 30, MicroP, a dental handpiece maker in Taiwan, announced that it has successfully obtained ISO 13485:2016 certification, as well as CE Marking and FDA 510(k) approvals. In addition to announcing that it had obtained all three certifications, it also announced that AG Neovo Dental, a well-known American dental equipment brand, had also placed orders with the company. As a partner of the NARLabs Medical Device Alliance, TUV Rheinland was pleased to witness MicroP, a young start-up, finish the complete preparation and certification process, together with the National Applied Research Laboratories cooperations. Max Lyou, Managing Director of TUV Rheinland Taiwan, was on hand to witness the contract-signing ceremony and express his felicitations.
MicroP, a young start up, began developing dental handpieces in 2013. All R&D is conducted in-house, and 95% of all parts are produced internally as well. The newly certified dental handpiece product is a basic medical device used in all dental clinics, which makes use of high-precision mechanical machining technology. The technical threshold is very high due to its stringent safety and quality requirements, such as high rotation speed, dynamic balance, and low noise. Only four Taiwanese dental instrument makers have successfully obtained FDA approvals for this product over the last decade. MicroP is now one of the few to have obtained CE Marking, quality management systems certification, and FDA approval all at once, in under two years.
New start-ups for medical devices have limited resources. Finding the right medical device certification body can be critical to successful certification. Some vendors go through the application process only to discover that their certification body has not been accredited by the International Accreditation Forum (IAF). Not being able to use their hard-won certification means time and money wasted. The conformity requirements for medical devices are particularly strict and rigorous. Finding a certification body with proper international accreditation as well as a complete testing and auditing team is the only way to steer a clear path through the complex review process.
TUV Rheinland headquarters is a notified body authorized by the Central Authority of the Länder for Health Protection (ZLG), the German equivalent of Taiwan’s Ministry of Health and Welfare. Mutual recognition for ZLG in all EU member states, and its leadership position, means greater acceptance in the European market. MicroP’s medical device CE Marking was approved by TUV Rheinland headquarters in Germany, and thus is trusted by European medical device customers. In addition to dental handpieces, applications for the CE Marking under the EU MDR directive can also be made for non-intrusive medical devices such as blood oxygen monitors, blood pressure monitors, ear thermometers, X-ray machines, and nebulizers (for asthma) intended for sale in Europe.
At the same time, the emphasis in ISO 13485 quality management system certification is on risk management. It is essential to ensure that products can satisfy the requirements set by the local authorities, no matter which market they are destined for. With an application for ISO 13485 certification with TUV Rheinland, applications for EU MDR, IVDR, and MSDAP certification can also be made at the same time, proving that the medical device’s production process complies with international medical device quality management standards and expanding the channels for market access.
MicroP’s development of a low-noise, high-speed dental handpiece that has gained ISO 13485:2016 certification for medical devices, CE Marking, and FDA 510k clearance all at the same time is proof that young start-ups can shorten their learning curve and quickly reach their target goals if they choose the right value partner.