Taiwan FDA reaffirms online sales ban for higher risk medical devices
Recently Taiwan FDA reaffirmed its position on the prohibition of on-line sales of contact lenses. As a Class II medical device, contact lenses cannot be sold on-line in Taiwan, where vendors could be fined 30,000 – 150,000 NTD (approximately AUD $1000 to $5000) for breaching the Taiwan Pharmaceutical Affairs Law.
Competent Authorities all over the world share a common concern that devices are being acquired through direct website orders without the required pre-market approvals. Taiwan however went one step further by enforcing an outright ban on the distribution of medical devices through online channels – even for products that have been approved and sold by certified Taiwan distributors. This is very different to TGA’s personal import scheme which allows procurement of unapproved therapeutic goods for personal use in Australia.
TFDA’s rationale was that medical devices, unlike common goods, often require face-to-face interactions with customers to demonstrate its use or to respond to enquiries. As a result, TFDA did not endorse any online trading – either through on-line home shopping television channels or catalogue ordering for devices. In late 2012 however, TFD relaxed this outright ban, allowing on-line trading of low risk devices.
Contact lenses, as Class II devices, are however not considered low risk. So while in most other jurisdictions contact lenses are commonly sold or bought online, one must undertake a face-to-face transaction for these products in Taiwan.
Are you confident that your sales person and website designer have the full regulatory compliance input required to keep you out of trouble in Taiwan? For more information on what is appropriate distribution methods for your product, please…