理工科技顧問股份有限公司 Qualtech Consulting Corporation

理工科技顧問股份有限公司 Qualtech Consulting Corporation Qualtech is a Medical Device Consulting and Clinical Trial (CRO) Company founded in 2000 by Dr. Chang.

Since its establishment, Qualtech has built its own culture to have integrity, a multidisciplinary background team, lifelong learning skills, and solid teamwork to provide satisfaction for the customers by giving high quality, efficient, and one-stop solutions for regulatory consulting and clinical trial services. Qualtech bringing such number of advanced products to successfully enter the emergin

g markets in Asia by establishing a strong partnership with each customer, and has built its reputation by providing good quality and efficient regulatory solution. Qualtech currently has established its own company in Taiwan, China, Singapore, Malaysia, Philippines, Indonesia and Hong Kong for providing local regulatory advice, product registration and license holding services.

📢 𝗝𝗼𝗶𝗻 𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵’𝘀 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗪𝗲𝗯𝗶𝗻𝗮𝗿: 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗔𝗡𝗭 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀Australia and New Zealand continue to be attractive desti...
01/06/2026

📢 𝗝𝗼𝗶𝗻 𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵’𝘀 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗪𝗲𝗯𝗶𝗻𝗮𝗿: 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗔𝗡𝗭 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀
Australia and New Zealand continue to be attractive destinations for medical device manufacturers seeking stable, high-value healthcare markets and internationally recognized regulatory systems.

To help manufacturers better understand the evolving ANZ regulatory landscape, Qualtech will be hosting a free webinar:
🔎 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗔𝗡𝗭 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀: 𝗔𝘂𝘀𝘁𝗿𝗮𝗹𝗶𝗮 𝗧𝗚𝗔 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 & 𝗡𝗲𝘄 𝗭𝗲𝗮𝗹𝗮𝗻𝗱 𝗘𝗻𝘁𝗿𝘆 𝗠𝗮𝗱𝗲 𝗦𝗶𝗺𝗽𝗹𝗲

📌 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗔𝗴𝗲𝗻𝗱𝗮:
• Introduction to ANZ Market Access & Qualtech Support
• Overview of TGA Application Pathways & Key TGA 2026 Updates
• New Zealand Regulatory Framework & Entry Strategy
• Q&A Session

𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗗𝗲𝘁𝗮𝗶𝗹𝘀:
📆 Date: Thursday, 18 June 2026
🕓 Time: 4:00 PM (GMT+8) | 10:00 AM (CEST)
🌏 Language: English
🔗 Register here: https://us02web.zoom.us/webinar/register/WN_Iazo7Ei7RT2R7euOm5YMUw

Participants are also welcome to submit their questions through the registration form for discussion during the webinar.

We look forward to welcoming you to this informative session.

𝗧𝗵𝗮𝗶 𝗙𝗗𝗔: 𝗡𝗲𝘄 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗢𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲 𝗡𝗼𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀Are you planning product updates, software changes, labelin...
28/05/2026

𝗧𝗵𝗮𝗶 𝗙𝗗𝗔: 𝗡𝗲𝘄 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗢𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲 𝗡𝗼𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀
Are you planning product updates, software changes, labeling revisions, or supplier changes for medical devices in Thailand?

🔔 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝘂𝗽𝗱𝗮𝘁𝗲:
In March 2026, the Thai FDA released a new and much stricter Change Notification Guidance - expanding both what must be reported and how it’s reviewed.
✅ More changes now require notification
✅ Major vs. minor changes are clearly defined - but easy to misclassify
✅ Fees, timelines, and documentation depend on risk level

Even seemingly small updates - like adding accessories, adjusting IFU wording, or changing material suppliers - can trigger regulatory action.

👉 Choosing the wrong pathway could mean delays, higher costs, or re‑registration.

Want the full picture?
𝗙𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲𝘀: https://lnkd.in/gESaj-vB

With over 𝟮𝟱 𝘆𝗲𝗮𝗿𝘀 𝗼𝗳 𝗲𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲, Qualtech Consulting Corporation helps medical device companies stay compliant – without slowing innovation.

🚀 𝗩𝗶𝗲𝘁𝗻𝗮𝗺 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗼𝗿𝘁𝗮𝗹 𝗗𝗼𝗺𝗮𝗶𝗻 🇻🇳Vietnam’s Ministry of Health has announced a domain transition for its ...
26/05/2026

🚀 𝗩𝗶𝗲𝘁𝗻𝗮𝗺 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗼𝗿𝘁𝗮𝗹 𝗗𝗼𝗺𝗮𝗶𝗻 🇻🇳
Vietnam’s Ministry of Health has announced a domain transition for its medical device public service portal, aiming to enhance system performance and user accessibility.

📌 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• New portal domain: https://vimda.moh.gov.vn
• Effective from April 1, 2026
• Upgrade designed to improve system efficiency and user experience

⏳ 𝗧𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝗔𝗿𝗿𝗮𝗻𝗴𝗲𝗺𝗲𝗻𝘁
• Existing domain will remain active until September 30, 2026
• Both portals will run in parallel during the transition period
• Users are encouraged to switch early to avoid potential disruptions

💡 Companies should update internal processes and bookmarks to ensure uninterrupted access to regulatory services.

🔗 Read our full article for more details: https://lnkd.in/gkrTDYNk

🤝 Whether you are managing registrations or navigating regulatory systems in Vietnam, our specialists are ready to support you: https://lnkd.in/gceJrKeu

🚀 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 🇲🇾Malaysia’s Medical Device Authority (MDA) has released the 2nd editio...
22/05/2026

🚀 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 🇲🇾
Malaysia’s Medical Device Authority (MDA) has released the 2nd edition of its guidance on the definition of medical devices, providing clearer interpretation to support product classification and regulatory compliance.

📌 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Expanded clarification on what qualifies as a medical device, including accessories, components, and spare parts.
• Accessories are regulated as medical devices, while components and spare parts are not considered standalone devices.
• Spare parts must maintain the original safety and intended purpose without altering device design.

📋 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗺𝗽𝗮𝗰𝘁
• The guidance helps stakeholders determine whether products fall within the scope of medical device regulation.
• Provides greater clarity for classification, reducing regulatory uncertainty.

💡 Companies should reassess product portfolios to ensure accurate classification and compliance under Malaysia’s regulatory framework.

🔗 Read our full article for detailed insights: https://lnkd.in/gVBr2TNF

🤝 Whether you are reviewing product classification or planning market entry in Malaysia, our regulatory specialists are ready to support you: https://lnkd.in/gceJrKeu

🚀 𝗦𝗶𝗻𝗴𝗮𝗽𝗼𝗿𝗲’𝘀 𝗛𝗦𝗔 𝗔𝗰𝗵𝗶𝗲𝘃𝗲𝘀 𝗪𝗛𝗢 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗟𝗲𝘃𝗲𝗹 𝟰 🌏Singapore’s Health Sciences Authority (HSA) has attained the World Heal...
20/05/2026

🚀 𝗦𝗶𝗻𝗴𝗮𝗽𝗼𝗿𝗲’𝘀 𝗛𝗦𝗔 𝗔𝗰𝗵𝗶𝗲𝘃𝗲𝘀 𝗪𝗛𝗢 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗟𝗲𝘃𝗲𝗹 𝟰 🌏
Singapore’s Health Sciences Authority (HSA) has attained the World Health Organization (WHO) Maturity Level 4, the highest recognition for medical device regulatory systems, reinforcing its position as a global regulatory leader.

📌 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀
• The recognition was announced in March 2026 during the IMDRF session held in Singapore
• WHO’s assessment validated HSA’s regulatory framework across the full product lifecycle
• The evaluation included technical reviews, regulatory evidence, and system performance

🌐 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗺𝗽𝗮𝗰𝘁
• HSA is now a global reference authority, enabling greater regulatory reliance by other markets
• Devices approved in Singapore may benefit from faster or simplified pathways internationally
• Strengthens Singapore’s role as a key gateway for regional and global market access

💡 This milestone highlights increasing alignment and convergence in global medical device regulations

🔗 Read our full article for more insights: https://lnkd.in/gfgZn4RV

🤝 Whether you are planning market entry in Singapore or leveraging reliance pathways, our regulatory specialists are ready to support you: https://lnkd.in/gceJrKeu

🚀 𝗧𝗵𝗮𝗶𝗹𝗮𝗻𝗱 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗲𝘀 𝗙𝗮𝘀𝘁 𝗧𝗿𝗮𝗰𝗸 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 🇹🇭Thailand’s FDA has launched a Fast Track pathway to accele...
18/05/2026

🚀 𝗧𝗵𝗮𝗶𝗹𝗮𝗻𝗱 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗲𝘀 𝗙𝗮𝘀𝘁 𝗧𝗿𝗮𝗰𝗸 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 🇹🇭
Thailand’s FDA has launched a Fast Track pathway to accelerate change notifications for essential medical devices impacted by supply chain disruptions, supporting continued product availability during ongoing global challenges.

📌 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Review timeline reduced from 15 working days to 5 working days for eligible change notifications
• Focused review on critical safety and performance documentation
• Designed to address disruptions in raw materials and packaging supply

⚠️ 𝗣𝗿𝗶𝗼𝗿𝗶𝘁𝘆 𝗦𝗰𝗼𝗽𝗲
• Applies to essential, high-demand devices on the Watch List, such as dialysis equipment, IV sets, catheters, and infection control products
• Excludes major changes such as indications or manufacturing site updates

💡 This initiative reflects a pragmatic regulatory response to ensure continuity of critical medical supplies.

🔗 Read our full article for more details: https://lnkd.in/gfwsr9JQ

🤝 Whether you are managing change notifications or navigating regulatory pathways in Thailand, our specialists are ready to support you: https://lnkd.in/gceJrKeu

15/05/2026

🌐 𝗚𝗹𝗼𝗯𝗮𝗹 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲, 𝗘𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗖𝗵𝗶𝗻𝗮 𝗠𝗮𝗿𝗸𝗲𝘁 𝗘𝗻𝘁𝗿𝘆 — 𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵 𝗮𝘁 𝗖𝗠𝗘𝗙 𝟮𝟬𝟮𝟲
In April 2026, Qualtech proudly participated in the 91st China International Medical Equipment Fair (CMEF) in Shanghai, engaging with medical device innovators and industry leaders from around the world.

With over 25 years of experience, our team continues to combine deep regulatory expertise with strong local connections across China, working closely with domestic manufacturers and stakeholders to bridge global expectations with local compliance realities.

💡 𝗦𝘂𝗽𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗚𝗹𝗼𝗯𝗮𝗹 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 𝗘𝗻𝘁𝗲𝗿𝗶𝗻𝗴 𝗖𝗵𝗶𝗻𝗮
At this year’s exhibition, many international companies visited our booth seeking guidance on China market entry. Our experts shared practical, experience-driven insights on:
• China registration pathways and timelines
• Documentation preparation and localization
• Regulatory review challenges and risk mitigation
• Clinical evaluation and testing requirements
• Navigating evolving NMPA regulations

Thanks to our on-the-ground presence and close collaboration with local manufacturers, we help global clients move forward with clarity and confidence in one of the world’s most complex regulatory environments.

🤝 𝗧𝗿𝘂𝘀𝘁𝗲𝗱 𝗳𝗼𝗿 𝟮𝟱 𝗬𝗲𝗮𝗿𝘀 We are deeply grateful for the trust our clients and partners have placed in Qualtech over the past 25 years. Your continued support drives us to deliver practical, reliable, and high-quality regulatory solutions worldwide.

💬 CMEF 2026 was a valuable opportunity to exchange ideas, strengthen partnerships, and support companies expanding across China, ASEAN, and beyond.

📧 Although the exhibition has concluded, our support continues. For inquiries, reach us at [email protected]
𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵 — 𝗚𝗹𝗼𝗯𝗮𝗹 𝗥𝗲𝗮𝗰𝗵, 𝗟𝗼𝗰𝗮𝗹 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲

🚀 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗜𝘀𝘀𝘂𝗲𝘀 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗢𝗯𝘀𝗼𝗹𝗲𝘁𝗲 & 𝗗𝗶𝘀𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲𝗱 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 🇲🇾Malaysia’s Medical Device Authority (MDA) has in...
13/05/2026

🚀 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗜𝘀𝘀𝘂𝗲𝘀 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗢𝗯𝘀𝗼𝗹𝗲𝘁𝗲 & 𝗗𝗶𝘀𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲𝗱 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 🇲🇾
Malaysia’s Medical Device Authority (MDA) has introduced a new guidance document outlining the application process for confirming the status of obsolete and discontinued medical devices, ensuring continued control over legacy devices still in use.

📌 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀
• Devices may qualify as “obsolete” or “discontinued” if registration can no longer be maintained but they remain in safe, functional use.
• Applications must be submitted by manufacturers or Authorized Representatives with supporting declarations and transition plans.
• A processing fee applies, with a 10-working-day review timeline upon complete submission.

📋 𝗣𝗼𝘀𝘁-𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗢𝗯𝗹𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝘀
• Approved devices cannot be newly imported or distributed.
• Ongoing maintenance, technical support, and post-market responsibilities are required.
• Records must be retained for 5 years, and authorities may mandate discontinuation if safety concerns arise.

🔗 Explore full details in our article: https://lnkd.in/gyApv9Pa

🤝 Whether you are managing legacy devices or preparing exemption applications in Malaysia, our regulatory specialists are ready to support you with tailored guidance: https://lnkd.in/gceJrKeu

🚀 𝗝𝗮𝗽𝗮𝗻 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗦𝗮𝗠𝗗 𝗮𝗻𝗱 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 🇯🇵💻Japan has issued new clarifications on Software as a Medical Devi...
11/05/2026

🚀 𝗝𝗮𝗽𝗮𝗻 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗦𝗮𝗠𝗗 𝗮𝗻𝗱 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 🇯🇵💻
Japan has issued new clarifications on Software as a Medical Device (SaMD), covering software distribution, statutory labeling, and cybersecurity responsibilities for connected medical devices. These updates reflect the country’s stronger focus on digital health compliance and patient safety.

📌 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• SaMD marketing begins when software is released on app stores or download platforms. Provision occurs when users activate the software.
• Required labeling and precautions may be provided electronically if easily accessible to users.
• Key safety information should be available before use and after major software updates.

🛡️ 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗘𝘅𝗽𝗲𝗰𝘁𝗮𝘁𝗶𝗼𝗻𝘀
• Roles for VPN and connected network devices should be clearly defined.
• Firmware must remain updated, and unsupported devices should be replaced.
• Stronger authentication and access controls are encouraged.

🔗 Further details on Japan’s latest SaMD requirements can be found in our full article: https://lnkd.in/gAN8vGfc

🤝 Whether you are preparing SaMD registration, e-labeling, or cybersecurity compliance in Japan, our regulatory specialists are happy to offer a free consultation and answer your questions: https://lnkd.in/gceJrKeu

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