Stick-on fever indicators that change colors according to body temperatures will be available at discount stores and supermarkets, the government said.

“Color-displaying thermometers,” widely known as stick-on fever indicators, are used as disposable thermometers to check fever on children.

Stick-on fever indicator Fever Bugz (Febur Bugz website)

The Ministry of Food and Drug Safety said on Friday that it would put to public notice an amendment to the “Regulations on the approval, report, and review of medical devices” and collect opinions about the revision until June 14.

The government plans to exclude sellers of stick-on fever indicators from reporting for medical device sales business, which will widen consumers’ access to the products.

To sell medical devices, a company must report the sales of related products to the ministry. If not, the company cannot sell the product.

As fever stickers are medical devices, only the businesses that reported the sales of such products were allowed to sell the fever stickers.

However, the ministry decided to exempt the rule because fever stickers are mostly used for children’s health and disposable.

If a company wants to add the same product line that has already been proved as in-vitro diagnostic medical devices, it can obtain approval without a technical documentation review.

The change is likely to reduce the burden on medical device suppliers. However, those excluded from the latest move are Class IV in-vitro diagnostic medical devices, serotype and subtype reagents, transfusion reagents, in-vitro diagnostic medical devices for field inspections and personal use, and in-vitro diagnostic medical devices for which the intended use is altered.

For manufacturers of electricity-using medical devices, the government extended the choice for inspection institutions to receive test results.

In the past, the inspection was available only at institutions designated by the minister of food and drug safety and the internationally accredited test bodies.

From June, companies will be able to receive test results from agencies recognized by the International Laboratory Accreditation Cooperation. ILAC is an international cooperative organization, comprising of accreditation bodies in each country.

“The amendment will help relieve the burden on medical device manufacturers. We will continue to streamline unnecessary administrative procedures that are not related to the safety of the public,” the ministry said.

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