– NMPA grants Syntellix product approval for the world’s most important future market with more than 1.4 billion people
– Syntellix had already been granted by the NMPA against the background of the special advantage of its products, the accelerated “innovative pathway” was granted
– So far, product registrations in countries have been achieved with more than 5.5 billion inhabitants; Product relationships in 73 countries and regions had already been reached on 5 continents
– Product approval in China was the most important strategic and operational goal of society
– Development of the prioritized core markets of China, India and Asean takes place via the Syntellix Asia PTE LTD in Singapore as a production facility and Sales Hub
– Syntellix boss Claassen: “After 17 years of work and 7 years of focus on China, we have achieved what almost all considered impossible and some wanted to prevent. As a startup from Hanover, we have written a pioneering story worldwide, the global medical success of which is no longer permanent. Whoever wins in China is strategically and operational.”
Syntellix AG has from Chinese NMPA (National Medical Products Administration) in Beijing, which is responsible for the regulation, registration and monitoring of medical devices for the Chinese market from the state side to receive product approval for the People’s Republic of China. This product approval for the world’s most important future market with more than 1.4 billion people is by far the largest and most important success in the company history of Syntellix AG, which the development of the huge Chinese market after taking office by Professor Dr. Utz Claassen had declared the CEO of the Society for the Supreme Strategic Priority. After the NMPA had already been granted the accelerated “innovative pathway” from the NMPA against the background of the special advantage of its products, the initial approval process has now ended positively and extremely successfully. It was the most complex, most intense and differentiated approval process that Synellix has ever underway with regard to product safety and quality management system.
Syntellix now has a total of more than 5.5 billion inhabitants, more than two thirds of the world’s population. Syntellix had previously received product registrations in 73 countries and regions on 5 continents, including in addition to all over Europe, Australia and New Zealand, South Africa, Singapore, Israel and Saudi Arabia, also strongly growing -dynamic countries such as Indonesia, Vietnam, the Philippines or Thailand and the most populous country in the world. China and India with a total of almost 3 billion inhabitants open up to the company from a lot of aspects of potential of completely new magnitude.
With the product approval for China, Syntellix has achieved the most important strategic and operational goal of the company. The strategic decision to open up and expand the prioritized core markets of China, India and Asean via the Syntellix Asia PTE LTD in Singapore and to locate and expand the main production location in the state -of -the -art and highly efficient island state of Singapore, and completely correctly. The establishment of an Asian-centered production chain was strategically and surgically the right decision, since the majority of the world can be supplied and operated faster from the Singapore production and sales hub Singapore than from Germany and Europe. In China, India and the Asean region alone, more than 3.5 billion people and thus dimensional live more than 40 times the population of the Federal Republic of Germany, and at the same time with much higher dynamics with regard to population growth as well as the growth of market and economic strength.
For this purpose – the establishment and expansion of manufacturing in Singapore, the development of the South Asian, Southeast Asian and East Asian markets as well as the achievement of the initially required corresponding products, especially in China – had Syntellix boss Professor Utz Claassen, which is also Executive Chairman & CEO of the Syntellix Asia PTE LTD in Singapore, and coordination with the Supervisory Board of Syntellix AG more than 5 years ago moved his personal residence from Germany to Singapore.
Accordingly, Synellix boss Professor Utz Claassen commented on the product approval now achieved in China: “After more than 17 years of work and more than 7 years of focus on China alone, we have made almost all of them to be impossible and wanted to prevent some. As a startup from Hanover, we have written a pioneer history worldwide, whose global medical success is no longer standing in China is strategic and operational The best positioned for our highly innovative products and more operations than most countries of the European Union. To be able to do this.
Claassen also emphasizes the abstract and concrete positive framework for the successful development of the Syntellix activities in Asia and is grateful for the very positive environment: “I expressly thank our outstanding Chinese partners for the great support and cooperation and at the NMPA for an outstandingly differentiated and structured admission process. (EDB) of the Republic of Singapore for the fact that he has continued to find the operational-structural basis of our rollout in Asia through competence and expansion of our manufacturing facility in Singapore, which is now also the Sales Hub. also set new standards in biomedicine technology. “
About Syntellix:
Syntellix AG, a global pioneer in biomedicine technology, material & life science, is the only company in the world with approvals for bioabsorbable metallic implants in more than 70 countries on 5 continents and tens of thousands of successfully carried out operations as well as the highest patient satisfaction of global protagonists and market and technology leaders in the field of bioabsorbable orthopedic Implants. The company was honored with numerous significant awards and prizes, including the innovation prize of the German economy, the future award of the German healthcare industry, the German Medical Award, the Step Award, the award as “Innovator of the Year” and the German Innovation Award in Gold as well as internationally as “Product of the Year” at Sustainability Award. In the meantime, more than 50 medical-scientific specialist publications have security, effectiveness and reliability of the Magnetiz® implants developed by Syntellix, which are described as “advantageous” for numerous clinical applications and even “clinically superior” over conventional titanium implants.
The Syntellix Asia PTE LTD in Singapore is a 100%subsidiary of Syntellix AG. It is the surgical heart of the group. In Singapore there is the production facility of the highly innovative Magnetiix® implants, and from the Syntellix Asia PTE LTD, which in turn has the subsidiaries Syntellix China PTE LTD, Syntellix Philippines Incorporated in San Juan City and Syntellix India Private Limited in New Delhi as well as in Jaipur/Rajasthan Leading Medical Hub Singapore itself also serves large markets of population dynamic countries in the entire Asean region, including Thailand, Malaysia, Vietnam and Indonesia.