KTC, Signs Agreement with Chinese Medical Device Designated Testing Institution and Expands Business Support for Chinese Export
KTC Signs Business Agreement with Chinese Medical Device Designated Testing Institution, GRG TEST, to Support Export of Domestic Companies to China
"To Enhance Competitiveness of Domestic Exporters Toward China through NMPA Certification Support"
▲A photo of the signing ceremony (from left to right: Mr. Chen Qi, Vice President of GRG TEST, and Director An Sung-il of KTC).
The Korea Testing Certification (KTC), led by Director An Sung-il, signed a business agreement with GRG TEST, a designated testing institution for medical devices in China, on March 12th at the KTC headquarters in Gunpo, Korea, to support the export of medical devices from domestic companies to China.
The market size of the Chinese medical device market was approximately $35.6 billion as of '22 and is expected to grow significantly to around $48.8 billion by '26 due to aging population and increased awareness of health post-COVID-19.
To export medical devices to the growing Chinese market, domestic companies need to obtain NMPA certification in accordance with Chinese national standards. Therefore, domestic companies have been sending samples to testing institutions designated by the Chinese government and conducting local tests to obtain certification. However, this process has been burdensome for the industry due to issues such as overseas sample shipping problems and difficulties in handling debugging incidents, resulting in significant time and cost.
Furthermore, with the enforcement of the Chinese version of the IEC 60601-1 3rd edition, GB9706.1-2020, starting from May '23, obtaining NMPA certification is expected to become even more challenging.
However, through this agreement, domestic medical device export companies will be able to undergo on-site testing through KTC instead of sending samples to China, thereby significantly reducing transportation costs and testing periods. Moreover, it will resolve communication difficulties between companies and testing certification institutions, which were considered the biggest hurdles in obtaining certification through overseas institutions.
Additionally, KTC will host a joint seminar with GRG TEST at the International Medical Equipment and Hospital Equipment Exhibition (KIMES 2024) at COEX from March 14th to 17th with the theme of "Chinese Medical Device Certification" to assist domestic medical device companies in entering the Chinese market. The seminar will be held in KIMES Seminar Room 311 from 14:30 to 16:30 on March 14th.
Moreover, in addition to medical device certification, KTC has promised to cooperate in various fields such as drones, 5G, electric vehicle chargers, and renewable energy, considering China as a significant trading partner, with an annual bilateral export trend to China reaching approximately $632.7 billion as of '23.
Director An Sung-il of KTC stated, "The medical device industry is a future growth industry and a nationally important industry, with continuous growth expected." He added, "Through this agreement, we will alleviate the difficulties of our companies in exporting medical devices to China and expand the scope of export support to the fields of drones, electric vehicle chargers, and renewable energy in the future."
KTC, as a global testing and certification institution leading the domestic certification industry, has been actively leading overseas certification by signing business agreements with 68 institutions from 36 countries to support the overseas expansion of small and medium-sized enterprises facing difficulties in overcoming new trade barriers such as technical regulations. In particular, with branches in Shanghai and Shenzhen, KTC plays a pivotal role in facilitating the export of domestic companies to China.
