From Vietnam to Indonesia: Two Markets Secured
Following its successful Class C registration in Vietnam, Medgen Life Science (Shenzhen) Co., Ltd. has achieved another breakthrough — its independently developed PRP preparation device has obtained Class B medical device registration in Indonesia. From Vietnam to Indonesia, Medgen has leveraged its solid technical capabilities to secure market access in two consecutive Southeast Asian markets, adding another critical coordinate to its global strategy.
Passing Indonesia's Ministry of Health Rigorous Review
This approval signifies that Medgen's PRP preparation device has passed the Indonesian Ministry of Health's rigorous review in terms of product safety, efficacy, and quality management systems, meeting the technical requirements of ASEAN medical device directives. This not only represents international authoritative endorsement of Medgen's product quality but also opens a compliant pathway into Southeast Asia's largest economy — a significant milestone in the company's globalization journey.
Multi-Product Portfolio, Parallel Internationalization
As a high-tech enterprise specializing in regenerative medicine, Medgen has consistently pursued a strategy of parallel independent R&D and internationalization. The company's core products have obtained multiple medical device registration certificates in China, including the pre-filled artificial bone BoneSwift™, oral bone filling material PoroGraft®, and PRP preparation device — all innovative medical devices.
This Indonesian Class B registration is another achievement in Medgen's strategy of cultivating markets along the Belt and Road. Going forward, the company will continue to advance product registration in additional Southeast Asian countries, build out localized service capabilities, and deliver high-quality regenerative medicine solutions to healthcare institutions and patients globally.
Looking Ahead
From China to Vietnam, from Vietnam to Indonesia, Medgen is expanding its global presence with steady, confident steps. The company will continue to build on quality as its foundation and compliance as its bridge, contributing Chinese innovation and solutions in regenerative medicine, demonstrating to the world the creative strength of Chinese medical device technology.