|
|
|
|
|
Newsletter | November 2015, Issue 3
|
|
|
|
|
|
|
TECHNOLOGY, MEDIA & TELECOMMUNICATIONS
|
|
|
|
Korea’s Food and Drug Safety Ministry Expands Its Regulatory Scope to Include Wellness Products
|
|
|
|
The convergence of two fast growing industries – the healthcare industry with the information & communications technology (“ICT”) industry – has led to the introduction of new products and services that include health-related functions (“wellness products”).
|
|
|
|
On July 10, 2015, the Ministry of Food and Drug Safety (“MFDS”) announced its guidelines on wellness products (“MFDS Guidelines”), with the goal to provide consistency and greater predictability in the industry. In it, the MFDS specifies the criteria for determining when the Medical Device Act should apply to wellness products.
|
|
|
|
Under the Medical Device Act, a “medical device” means an instrument, machine, device, material or any other similar product that is used – either alone or in combination with other devices – on human beings or animals for the purpose of:
|
|
|
|
| 1) |
Diagnosing, curing, alleviating, treating or preventing a disease;
|
| 2) |
Diagnosing, curing, alleviating or treating an injury or impairment;
|
| 3) |
Investigating, replacing, or modifying the anatomy of a physiological process; or
|
| 4) |
Birth control.
|
|
|
|
|
According to the MFDS Guidelines, whether a product constitutes a “medical device” (and thereby subject to the Medical Device Act) or a “wellness product” (not subject to the Medical Device Act) should be determined based on its “purpose of use” and “degree of risk.”
|
|
|
|
In principle, if the purpose is “for medical use,” then it would be considered a medical device. On the other hand, if the purpose is “not for medical use,” then it would be considered a wellness product. However, the MFDS Guidelines state that even if a product’s purpose is “not for medical use,” it may still be classified and regulated as a medical device if the product poses a significant degree of risk.
|
|
|
|
A product’s purpose is determined in light of the manufacturer’s objective intentions regarding the product’s method of use, which are reflected in the specifications, instructions, and in the information provided with the product.
|
|
|
|
In evaluating the degree of risk, the MFDS Guidelines set forth certain criteria, such as whether the product causes biocompatibility issues, and whether it may cause injury or disease to the user if the product fails to operate as intended.
|
|
|
|
The MFDS Guidelines also include specific examples of products with a high degree of risk and a low degree of risk.
|
|
|
|
Wellness Product Categories
|
|
|
|
According to the MFDS Guidelines, wellness products are largely divided into two categories based on their purpose: (i) general healthcare products; and (ii) self-care products for patients with chronic diseases.
|
|
|
|
“General healthcare products” are further divided based on their function and purpose into “products which measure and analyze biometric events,” “products which improve physical functionality,” “products which provide medical information for general healthcare,” and “products for exercise or leisure activities.”
|
|
|
|
“Self-care products for patients with chronic diseases” are further divided based on their function and purpose into “products which measure and analyze chronic conditions,” and “products which provide medical information for chronic disease management.”
|
|
|
|
Back to Main Page
|
|
|
|
|
|
If you have any questions regarding this article, please contact below:
|
|
|
|
|
|
|
|
For more information, please visit our website:
|
|
|
|
|
|
|
|