QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

2021-02-19

Some of the most rapidly ageing countries in the world can be found in Asia. According to World Economic Forum, globally, the working-age population will see a 10% decrease by 2060. The chart in Figure 1 shows an extrapolation made by the United Nations, whereby the geriatric pool in some major Asian countries is expected to take over the working-class population in the near future.

Figure 1: Growing Aging Population in Asia by 2050, Source: ADB Data Library

With a rapidly aging global population due to declining birth rates and increased life expectancy, a smaller workforce is slowing down economies and raising healthcare costs. Due to the rising healthcare expenses, more citizens are turning to the solutions offered by public-funded healthcare institutions, resulting in more government expenditure in these medical sectors.

Countries affected by a growing ageing population are building policies to address both, the growth of their economies and the rights of the elderly. More healthcare facilities being built, coupled with current ones being upgraded to cater to such growing ageing population drives the rehabilitative medical device market in many Asian countries. Furthermore, increasing number of road-accidents, mobility affecting diseases, non-communicable diseases coupled with growing geriatric patient pool is expected to stimulate the rehabilitation devices market growth in Asia.

Based on product, the rehabilitative and assistive equipment market is segmented into therapy equipment, daily living aids, mobility equipment, exercise equipment, and body support devices.

The therapy equipment segment accounted for the largest share of the market in 2019. The recent pandemic outbreak has shown how dependent some Asian countries are on oxygen therapy equipment to keep the aging patients surviving through. In addition, alternative treatment methods such as laser therapy, shock wave therapy, cryotherapy, and electrotherapy are also gaining more exposure in the market for their varied applications.

Moreover, rising prevalence of orthopedic disorders, especially among women, is expected to further boost the demand for rehabilitation devices. Additionally, presence of organizations such as the Society of Neurorehabilitation in more Asian countries, supporting patients with disabling neurological conditions, will positively influence the Asian rehabilitation devices industry growth.

Furthermore, mobility equipment segment holds a significant revenue size over the forecast years due to growing population base suffering with some kind of physical impairment. Devices such as walker, canes, crutches, and in recent times, bionic exoskeleton, provide increased confidence, greater independence, and reduces pain for the patients to overcome disability, caused by injuries or surgery.

Registration Requirements for Rehabilitative Equipment

As far as registration requirements are concerned for such rehabilitative and assistive equipment, they are pretty similar to conventional registration requirements for other medical devices. However, additionally, manufacturers who intend to market these devices in above-mentioned Asian countries need to pay extra attention to the biocompatibility, physical and mechanical test reports. More so often, these rehabilitative medical devices are active devices. Hence, manufacturers need to ensure electrical safety tests have been conducted, according to the latest local and international standards.

In Taiwan, it is the manufacturers obligation to identify suitable equivalent device to qualify for a standard evaluation route.

In China, certain electrical safety and mechanical tests need to be tested according to the local standards, in order to proceed with evaluations. The level of scrutiny and clinical data required during the evaluation process will be determined by the significance of the information being produced.

In Japan, some of devices, such as wheelchair, crunch, patient lift, etc. are classified as technical aid products, (福祉用具) instead of medical device. These devises shall comply with local standards and be registered in Technical Aids Information System (TAIS) for people in need to rent or purchase them.

Conclusion

As 2020 marks the beginning of The United Nations Decade of Healthy Ageing (2021-2030), the world is undoubtedly entering a pivotal period. Countries all over the world face tremendous pressure to effectively manage their aging populations and the demand to cater to this growing population rapidly catches up with other medical device market segments, especially in Asia. Jumping onto the bandwagon will yield promising results for manufacturers who are seeking to expanding the market further into Asia and contribute to the economic advancement of these countries, and allow populations—both young and old—to live long and prosper.

Qualtech will always keep you in the know with all such latest regulatory updates, just make sure you look out for our monthly Newsletters. We have assisted plenty of manufacturers to successfully market their rehabilitative medical devices, from the basic to the most advanced, in the robust Asia market. If you would like to follow suit, Qualtech is your perfect partner. Feel free to contact us!

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QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

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