Life Sciences (Medical Device Field)
Assisting FDA-approved medical product manufacturers
Analysis (2 weeks)
- NDA Signing: Ensuring data confidentiality.
- Customized Case Consultation: On-site visits or online meetings.
- Teams in Taiwan and the US conduct on-site visits or online meetings to confirm needs based on the client’s main concerns.
Regulatory Compliance
- Assisting in regulatory compliance checks for products based on local regulations to ensure adaptation to various national laws.
Solution (2-4 weeks)
- Become your local agent:
- Our company located in Silicon Valley (Northern California) (Newark, California) can be your agent in the United States.
- Conversely, for international companies entering the Asian market, our company in Taiwan is the most suitable agent.
- As an agent, we will assist you in communicating with local administrative authorities.
- Establishment of a qualified supplier list:
- Assist in developing compliant medical device manufacturers (ISO13485/QMS) / qualified regulatory affairs application service providers / willing cooperative distributors.
- FDA Certification Acquisition Plan:
- Assist in completing product item confirmation/application document preparation/submission of application materials/agent communication and feedback.
- Success stories: Cardiovascular rehabilitation solution enters the Ukrainian market / Handheld ultrasound equipment enters the Thai market.
- Competitive Analysis Report:
- Provide in-depth reports for informed decision-making and strategy formulation.
- Assistance in establishing marketing tools/channels:
- New media marketing enables us to interact directly with interested parties.
Execution
- Participation in international exhibitions:
- ATA2023 / FIME 2023 / Pharma Vietnam 2023 / Medical Asia-Thailand 2024
- Medical Taiwan Expo 2023~2024 / Healthcare Taiwan Expo 2023~2024
- Participation in international BD/matchmaking meetings:
- Success stories: The Taiwanese medical device company collaborates with Welch Allyn in the US / Canadian medical device company collaborates with Taiwanese suppliers to develop new products and cross-agency distribution.
- Medical institution development:
- Success stories: Canadian medical device company collaborates with Taipei City United Hospital / Taiwanese medical device company collaborates with Bangkok Christian Hospital.
Success Stories (Cardiovascular / Ultrasound)
In 2023, during the pandemic, we held a video conference with a Ukrainian distributor to share the solution offered by a Taiwanese smart health center system provider (GSH). Our solution covers 2 AI robots, 3 series of smart devices, and 4 major cloud platform modules.
Starting in May 2024, the Ukrainian client informed us that the country’s largest cardiovascular rehabilitation center – STATE INSTITUTION “SCIENTIFIC AND PRACTICAL MEDICAL CENTER OF CHILDREN’S CARDIOLOGY AND CARDIAC SURGERY OF THE MINISTRY OF HEALTH OF UKRAINE” – would continue with this project.
After signing an NDA and confirming regulatory compliance, we successively completed the document submission and passed the online audit by the Ukrainian Ministry of Health. In November 2024, the Taiwanese system provider (GSH) obtained Ukrainian medical device certification for its solution and assisted the local distributor in winning the bid.
Developing countries have a strong need for cardiovascular rehabilitation solutions. Starting with the Ukrainian and Eastern European markets is our first step in developing the European and American markets.
In 2019, we first introduced a handheld ultrasound product from Taiwan to a Thai distributor. This product, which had already obtained Class 2 medical device certification in Taiwan, had successful sales experience and secured investment from the electronics giant ASUS. We designed and manufactured the first ultrasound device for ASUS’s brand.
The product also experienced rapid growth in the Thai market, successively obtaining Thai medical device certification for the LU700 series in 2021 and the LU710 series in 2023. There are plans to obtain Thai medical device certification for their latest LK128 series in 2025.
This is one of the many successful cases UpSynergy has facilitated, establishing a successful model for Taiwanese manufacturers to develop overseas markets. It combines regulatory compliance confirmation, qualified supplier development in the target market, local medical device certification acquisition planning, order acquisition, and product export, resulting in stable revenue growth.