• 2024-06-20 07:07:12

South Korea's medical device market is flourishing, driven by a surge in demand for advanced technologies. This trend, coupled with a high reliance on imports (67% in 2021), creates a promising opportunity for international manufacturers of innovative devices. However, navigating this dynamic market effectively requires a strategic approach to secure a foothold in this Asian powerhouse.

• 2024-06-20 06:42:03

South Korea boasts a thriving contact lens market. Driven by a high prevalence of myopia (nearsightedness) and a growing preference for stylish and functional eyewear, Korea presents a lucrative opportunity for global contact lens manufacturers. This article explores the factors fueling the Korean contact lens market, the reasons why it’s ripe for foreign investment, and the key considerations for success.

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.

• 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

• 2023-10-27 01:27:54

South Korea's thriving medical device industry offers promising opportunities for companies, driven by a robust healthcare infrastructure, a growing aging population, government support, and rising healthcare spending. Qualtech invites interested manufacturers aiming to enter this dynamic market to partner with Qualtech to successfully navigate the approval process and maximize the product's potential.

• 2023-09-28 06:42:53

Qualtech is excited to invite you to an insightful webinar: Asia's Business Frontier: Korea Market Expansion & China Registration Service Updates!

• 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .

• 2020-02-21 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.