March 6, 2017
TUV Rheinland recently hosted an ‘All Quality Matters Forum’ on mobility aids safety in Taichung, Taiwan, focused on export quality and European standard requirements for mobility aids.
During the forum, experts from related industries, including Dr. Chang Wan-Lan from the Cycling & Health Tech Industry R&D Center and Mr. Arthur Shen, project manager from the Precision Machinery R&D Center, each gave an explanation of wheelchair standards and common deficiencies found during FDA review and testing. TUV Rheinland experts then introduced quality requirements and solutions for mobility aid manufacturers exporting to the EU, so as to help manufacturers grasp the key regulatory highlights pertaining to mobility aids.
Taiwan has a rapidly aging population; by 2018 up to 14.5% of the population will be senior citizens, making Taiwan an aged society. In 2026 it will become a super-aged society, with 20.6% of the population seniors. The latest forecast from Moody’s suggests that the global population is aging as well, with 13 nations set to reach “super-aged society” status by 2020. This staggering growth in the number of senior citizens means that the growth potential of the global senior care industry over the next decade cannot be underestimated. Demand for associated medical aids can therefore only grow as well in the future.
Mobility aids include wheelchairs, electric mobility scooters, stair climbing devices, custom vehicles (or upgrade parts), walkers, and walking canes suitable for handicapped or senior users. A good aid product should not just provide assistance with obstacles. It should also be easy and safe to use. In addition to product design requirements, a basic requirement for entering the international medical devices market is adherence to the ISO 13485:2016 standard. This is the minimum quality standard for manufacturers. The new standard is more applicable to the overall medical devices supply chain, as well as more relevant to parts and service providers. The emphasis in the new edition of the standard is making risk management a part of the safety assessment for medical devices.
Taiwan’s medical device manufacturers have long been OEM suppliers to Western companies. Mobility aids are the key types of product exported to Western markets by Taiwan’s medical device industry. Manufacturers are often directed by buyers to change designs or specifications without knowing why or how to meet international regulations. To understand the standards requirements for international medical devices will not only facilitate market access, but will also help suppliers improve their competitiveness, and even push them to develop their own designs and then prove their product quality via voluntary certification.