Page 84 - 2018食藥署年報(英文版)

software, and magnetic resonance imaging software as Class 2 medical devices.
4. On March 16, 2017, the ban on five Class 2 medical devices was further lifted, including blood
pressure tourniquets, the motorized vehicle for medical purposes, powered wheelchairs, and
otolaryngology drug application devices.

Outcomes and Benefits

1. So far, the Administration has lifted the ban on sale of 739 items in total, including 721 low-risk
Class 1 medical devices and 18 medium-risk Class 2 medical devices, to make it convenient for

consumers to purchase medical devices on the Internet.
2. When medical devices are purchased online, frauds and the impossibility to return and replace
products, failure to operate a product, or health hazards caused by improper use, and issues
with after-sale maintenance of products are likely to happen. The Administration has conducted
classification on the overall risk of medical devices into consideration. For the time being,
medical devices having fulfilled the four principles indicated above have all been allowed to be
sold online. (Table 5-1) (Figure 5-4)

Table 5-1 Medical device items that can be sold by pharmaceutical companies
(pharmacies) through distance sales channels

Start Date Medical Device Items Product Demo
knee braces, Band-Aid, mechanical
November 1, 2012 Class I medical devices (721 items) wheelchairs
E.2770 Impedance plethysmography (impedance Body fat monitor
peripheral blood flow recorder)
L.5300 Condoms
Condoms
January 2, 2014 1.5310 Condoms containing spermicide
L.5460 Scented or deodorizing sanitary pads
Tampon
L.5470 Unscented sanitary pads
I.4040 Medical clothing Surgical masks
I.0004 Alcohol prep pads Alcohol prep pads, alcohol cotton balls
Iodine prep pads, iodine swabs, iodine
I.0005 Iodine pep pads
gauze
I.4014 External non-absorbent gauze or sponge Vaseline gauze
October 15, 2015 balls
J.5240 Medical sticky tape and sticky bandage Suture-free tape
M.5918 Rigid gas permeable contact lens
preserving products Contact lens cleansing solution, contact
M.5918 Flexible contact lens preserving products lens care solution
Medical image digitizer, communication
Medical device software
and storage device
Blood pressure tourniquets, blood
E.1120 Blood pressure tourniquets pressure cuffs, blood pressure
measuring armbands
L.5400 Menstrual cups Menstrual cups
March 16, 2017
O.3800 Motorized vehicle for medical purposes Motorized vehicle for medical purposes
Powered wheelchairs, powered walking
O.3860 Powered wheelchairs
aids installed on wheelchairs
G.5220 otolaryngology drug application devices Nasal irrigation devices, nasal sprays
82