In consideration of the development of the oncoming channels, such as Internet, TV shopping, mail-order purchases and etc. The channels provide more diverse choice for people to get goods.
To ensure the safety of using the medical devices, and to advance the approachability of the medical devices, Food and Drug Administration, Department of Health, Executive Yuan plans to open virtual channels, which have been mentioned above, selling low risk medical devices.
Moreover, “Primarily outlines for management of medical device selling through virtual channels” has been noticed, and will be announced and implemented in the near future for implementing the relevant administration.
According to the regulation of “Primarily outlines for management of medical device selling through virtual channels”, only medical device selling pharmacists, who hold the place of business in physical channel, are allowed to sell the medical devices through virtual channels.
The purpose is to ensure the availability of product tracking, and to guarantee that consumers can contact pharmacists when they have problems when using products.
Furthermore, on the basis of consideration for safety and risk of medical device products, virtual channels are opened to sell only Class I medical devices with low-risk, including Band-Aid, gauze, cotton swab, medical face mask (except the surgical mask), protective equipment, staylace, mechanical walker, mechanical wheelchair, etc..
In addition, the commonly see products of sell Class II and III medical devices with higher risk via the virtual channels at present, such as condom, blood glucose meter, blood fat instrument and disposable contact lens are not included in the open list this time.
As for whether Class II and III medical devices are opened to be sold through virtual channels or not will be depend on the future implementation situation.
It will be taken into consideration, after integral estimation of pharmacist management and the consumer safety.
Food and Drug Administration, Department of Health, Executive Yuan reminds consumers that while choosing a medical device through virtual channels, consumers should see clearly if this product has a permit license No. of Class I medical device issued by Department of Health (Wei-Shu-Yi-Cii-Jhih (Shu) Yi-Zhi-Di No. OOOOO). Moreover, take notice of the name of product, name and address of pharmacist, using direction, lot number, manufacturing date, expiry date, and other information.
If you have further questions, please visit Food and Drug Administration website, and search “Researching operation for permit license of drug, medical device, and cosmetic” system (http://licnquery.fda.gov.tw/DO8180.asp), or dial the consumer advice line offered by the pharmacist for inquiring.
If a bad quality medical device is found after use, or when a medical device causes a serious adverse reaction, you should inform National Adverse Drug Reactions Reporting Center set up by Department of Health according to “Announcement method of serious adverse drug reactions”.
Adverse drug reactions reporting hotline: 02-2396-0100, and website: http://adr.doh.gov.tw
These are all made to safeguard consumers own rights and interests.