PowerPoint Presentation

[Audio] Global Expertise, Local Insights Your Trusted Partner in Regulatory Consulting and Clinical Trials (CRO) for Medical Devices V.2025.01.

[Audio] Who We Are Since year 2000, Qualtech provides Regulatory Services across 18+ Countries. Our expertise ensures reliable and efficient product registration and license holding across these regions. With Qualtech's local offices and expert team in 14 countries, we can support global medical device manufacturers on markets entry and registration service. Besides, by collaboration with quality local partners, Qualtech has extended our service to Brazil, India, Kingdom of Saudi Arabia and United Arab Emirates. China South Korea Germany Japan UAE United States Taiwan Thailand Hong Kong Saudi Arabia Vietnam Philippines India Malaysia Singapore We have established local offices in key global markets, including the United States, Germany, Japan, Australia, China, South Korea, Singapore, Indonesia Brazil Taiwan, Malaysia, the Philippines, Hong Kong, Thailand, Indonesia, and Vietnam. Australia We are also expanding our services into Brazil, India, Saudi Arabia, and the UAE..

[Audio] Who We Are Qualtech's 120+ members across APAC region. Our expertise ensures reliable and efficient product registration and license holding across these regions. Our Members Medical Engineering PhD Biotechnology Biostatistics 10% Anatomy Chemical Engineering 40% Biomedical Image & Radiological Science Master Degree Pharmacist 120+ Physiology members Healthcare Management 50% Material Sciences Bachelor's Degree etc.,.

[Audio] Core Values Diversity, Teamwork, Where QT Cohesiveness Healthy & Happy Life, Contribution to Society Continuous Learning, Keep up with the Trend Strengths Align Qualtech Learning Center Experience Sharing Fitness Training Diverse Culture & Background Med Tech Training Medical Consultant Management Training Sessions Regular Global Team Meeting Qualtech Webinar Donation to local organizations Experts Meeting Team-building Activities Monthly Newsletter Qualtech News Sharing.

[Audio] Multi-Disciplinary Professional Team Clinical Research Department One protocol design for multi-registrations Co-ordinate clinical trials in various sites Clinical Evaluation Report-expedite registration pathway Regulation Affairs Department Navigate in regulatory landscape Rapid and precise response to authorities Streamline approval process and boost efficiency Business Development Service Update local market research Strategic planning Market research Partnership development Medical Science Research Integration Team Latest med-tech research collection Active investigation in medical device for aging population Professional evaluation of med-tech trend.

[Audio] How We Can Support Unlock global opportunities Empowering manufacturers to expand beyond boarders Product registration in targeted countries Oversea market expansion Regulatory plan and strategy recommendation during R&D 1. Protocol design 2. Execution of clinical trial 3. Clinical evaluation report 1 2 3 4.

[Audio] What We Do GMP: Product Registration Multi-Country: GLP Laboratory Test: PMS Sale Supporting: 1. Compliance with required standards 2. Qualified laboratory lists 3. Coordination of series lab tests. 1. Partner with Notified Bodies for setting up Quality Management System (QMS) 2. Assist client to prepare GMP audit by local authority. Australia, Brazil, China, Germany, Hong Kong, India, Indonesia, Japan, Kingdom of Saudi Arabia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand, Unite Arab Emirates, United States and Vietnam Distributor Research GMP PMS GCP GRP GLP GSP GDP Manufacturing Distribution Clinical Trial Research Registration Testing Post Market Surveillance GDP Importation: GRP: GCP Clinical Trial: Local Authorized Representative Regulatory plan and strategy recommendation during R&D Excellent performances in GCP Inspections in China and Taiwan since 2008, successfully coordinated various clinical trials for high-risk and implantable devices CER Medical Writing: We provide professional, comprehensive CERs that expedite product approvals and ensure compliance with EU MDR clinical requirements, with extensive experience across multiple regions..

[Audio] What We Do GMP GCP Manufacturing GSP Clinical Trial Registration GLP GDP Testing Distribution PMS GRP Medical Device Research Post Market Surveillance Life Cycle.

[Audio] Multi-Country Registration's Workflow ► One Contact, Global Reach Client Authorities Qualtech Client's product multimarket approvals Provide all technical files and supporting docs Contact to authorities in multimarket 10. Philippines FDA 11. Singapore HSA 12. South Korea MFDS 13. Taiwan FDA 14. Thailand FDA 15. UAE MOHAP 16. US FDA 17. Vietnam MOH 1. Australia TGA 2. Brazil ANVISA 3. China NMPA 4. Hong Kong MDD 5. India CDSCO 6. Indonesia MOH 7. Japan PMDA 8. KSA SFDA 9. Malaysia MDA.

[Audio] Why Qualtech? Your reliable and professional partner for regulatory compliance! 1. With just ONE set of technical documents 2. Qualtech provides multiple markets entry CUSTOMIZED strategies and regulatory solutions Efficient Communication with local authority 3. Dedicated project manager and monthly progress report 1. In-Depth and TIMELY update 2. Expert GUIDANCE on necessary actions Real-Time Access to Regulatory Updates 1. ONE contact to Qualtech for any registered product change or incident. 2. Instant update on product certificates status Seamless and Efficient Post-Market Management in various countries..

[Audio] Seamless Integration of Industry and Academia ► Qualtech's Contributions in Industry Development Qualtech Taiwan expert, invited as Symposium Speaker at Medical Expo Taiwan Qualtech Clinical Research Expert Sharing Experience at TFDA Clinical Trial Training Qualtech Malaysian and Vietnams experts were Co-operation with OMETA Overseas Medical Presentation in the 7th SoCal Taiwanese invited by TFDA, for Sharing Regulatory Updates in Technical Assistants, Japan Biotechnology Association Annual Symposium ASEAN Countries in California.

[Audio] Seamless Integration of Industry and Academia ► Med-Tech Training: Empowering Our Staff for Service Excellent ► Professional guest speakers from experts in government officials, universities and hospitals ► Training topics included Regulatory updates Research and development trends The latest innovation and technology Qualtech Learning Centre providing > 300 internal training sessions to all staff since establishment..

[Audio] Corporate Social Responsibilities Sharing is caring. ► Primary Education Scholarship Sports development Teaching equipment ► Tertiary Education Doctorial program Laboratory equipment Exchange program ► Non-government and Religious Organization Festival celebrations Gifts for disabled group Support local agricultural network ► Dedication to Aboriginal Junior Choir ► Indonesia Badminton Team For local cultural preservation and all-rounded personal development.

[Audio] Corporate Social Responsibilities Sharing is caring. ► Sponsor to Junior School Band ► Donation to Taipei Medical University.

[Audio] Your Gateway to Multiple Markets Contact Us Registration & Clinical Trial Ms. Irene Lu [email protected] Email us with any questions or inquiries. We would love to hear from you. 理工科技顧問股份有限公司 Qualtech Consulting Corporation Qualtech Medical Device Consulting WeChat ID: Qualtech北京纽创.