Product Registration of Cartilage Implants in Singapore
In 2003, the World Health Organization WHO appointed the first decade of the new millennium the bone and joint decade.
The WHO was caused to do so by the tremendously increasing number of people suffering under the burden of musculoskeletal pain. Roughly 30 % of all American adults are affected by joint pain and by limitation of movement. Interestingly, in highly developed regions like the US, Canada and Western Europe, twice as much persons are suffering of osteoarthritis, as compared with South-east Asia. The root cause for this are lifestyle factors, such as obesity and lack of physical activity. If the economic revival – as we can observe in the last years – of South-east Asia continues and people go on changing their lifestyle with the urbanization and motorization of the developing world, a new highly profitable market for cartilage implants will arise.
For example Singapore: the economic rise cannot be stopped. The Health Sciences Authority (HSA) is in charge for registration of medical devices. Similar to the FDA, the HSA classifies medical implants in a high risk class, named Class D (FDA: Class III). But for all who already have gotten approval from the FDA and holding a Premarket Approval Application (PMA), the HSA offers an abridged evaluation route, which brings cost for review and registration down to nearly the half, in around 220 days.
Why not thinking about a HAS approval in Singapore? It is surely an attractive market!
Dr. Alexander Elsässer
World Health Organization. The burden of musculoskeletal conditions at the start of the new millennium: report of a WHO scientific group. Geneva, Switzerland: WHO, 2003.
Woolf, A.D., and Pfleger, B. Burden of major musculoskeletal conditions. Bulletin of the World Health Organization 81, 646, 2003.
GN-15: Guidance on Medical Device Product Registration (Revision 6.1)