ITC (Institute for Testing and Certification)

ITC is an abbreviation of "Institute for Testing and Certification", headquartered in Czech Republic and authorized by Europe Union directly. Its NB No. Is 1023.

We ITC CERT received exclusive authorization from ITC for CE marking settled in Seoul, Korea. And the certificate range is as the following:
(1) MDD(93/42/EEC)
(2) IVD(98/79/EC)
(3) AIMDD(90/385/EEC)
(4) EMC(2004/108/EC)
(5) LVD (2006/95/EC)
(6) PPE(89/686/EEC)
(7) TOY(88/378/EEC)
(8) CPD(89/106/EEC)
(9) PED(97/23/EEC)

Thereinto, we are professional at MDD, IVD and AIMDD products certification as we did have plenty of expriences on these products. The higher the product classfication is, the more obvious our advantages and expertises are. Absorbable products such as Surgical Suture, Biological Collagen Sponge, Gelatine Embolism, Hemostatic Sponge, Hyaluronic products; Implantable prodcuts such as Silicon Breast Implants, IUD, Osteopathy Implants, Stents, Medicated Stents, and so on.

Except those strong points we can also provide the following extra services in case of medical device areas:
-We have our own FDA designated Agency in USA for FDA listing and 510(k) approval
-We can support your clients for the approval of medical devices in Korea through our support for KFDA approval from long experiences.
-We also have cooperation institutes and companies in Japan so as to provide you certification in MHLW in Japan.
-Gost certification in Russia.

We have independent technical supporting company for the offer of competitive "One Stop Service" to clients. Pls feel free to contact

With me at any time to know more about us ITC. And looking forward to our cooperation in the near future.