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 emerging 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.

𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗶𝗻𝗴 𝗝𝗮𝗽𝗮𝗻 𝗼𝗿 𝗦𝗼𝘂𝘁𝗵 𝗞𝗼𝗿𝗲𝗮? 𝗦𝘁𝗮𝗿𝘁 𝗪𝗶𝘁𝗵 𝗧𝗵𝗲𝘀𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗣𝗼𝗶𝗻𝘁𝘀For medical device manufacturers, entering a new mar...
04/09/2026

𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗶𝗻𝗴 𝗝𝗮𝗽𝗮𝗻 𝗼𝗿 𝗦𝗼𝘂𝘁𝗵 𝗞𝗼𝗿𝗲𝗮? 𝗦𝘁𝗮𝗿𝘁 𝗪𝗶𝘁𝗵 𝗧𝗵𝗲𝘀𝗲 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗣𝗼𝗶𝗻𝘁𝘀
For medical device manufacturers, entering a new market often starts with a simple question: 𝗖𝗮𝗻 𝘁𝗵𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘄𝗼𝗿𝗸 𝗮𝗻𝗱 𝗱𝗮𝘁𝗮 𝘄𝗲 𝗮𝗹𝗿𝗲𝗮𝗱𝘆 𝗵𝗮𝘃𝗲 𝗯𝗲 𝘂𝘀𝗲𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗺𝗮𝗿𝗸𝗲𝘁?

In Japan, this can be particularly relevant when preparing biocompatibility documentation for PMDA. Understanding how existing reports may be leveraged can help manufacturers assess their submission strategy before starting additional work or testing.

In South Korea, the regulatory landscape is evolving for digital healthcare products and digital medical devices. Manufacturers developing software-based or digitally enabled products need to understand how these developments may affect their regulatory pathway and market entry plans.

🔎 𝗪𝗵𝘆 𝗶𝘀 𝘁𝗵𝗶𝘀 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 𝗿𝗲𝗹𝗲𝘃𝗮𝗻𝘁?
These are not just regulatory updates. They can affect how you:
• Prepare your technical documentation
• Assess existing test data and reports
• Plan your regulatory submission
• Determine the right approach for innovative and digital products
• Prepare for market entry in Japan and South Korea

Join our upcoming webinar for a practical discussion on these developments, followed by a live Q&A with our regulatory experts.
📌 𝗧𝗼𝗽𝗶𝗰𝘀:
🇯🇵 Japan – Leveraging Existing Biocompatibility Reports for PMDA
🇰🇷 South Korea – Digital Healthcare Products Act & Digital Medical Devices

📆 Date: 17 September 2026
🕓 Time: 4:00 PM (GMT+8) | 10:00 AM (CET)
🔗 Register: https://us02web.zoom.us/webinar/register/WN_1nXqwoSPROanr_LE6jU1Kg

If Japan or South Korea is part of your market expansion plans, this is a conversation worth joining.

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗵𝗼𝗺𝗲-𝘂𝘀𝗲 𝗦𝗮𝗠𝗗 𝗱𝗲𝗺𝗼𝗻𝘀𝘁𝗿𝗮𝘁𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘃𝗮𝗹𝘂𝗲 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗰𝗿𝗲𝗮𝘁𝗶𝗻𝗴 𝗻𝗲𝘄 𝗿𝗶𝘀𝗸𝘀 𝗳𝗼𝗿 𝘂𝘀𝗲𝗿𝘀?As health monitoring increasi...
04/09/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗵𝗼𝗺𝗲-𝘂𝘀𝗲 𝗦𝗮𝗠𝗗 𝗱𝗲𝗺𝗼𝗻𝘀𝘁𝗿𝗮𝘁𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘃𝗮𝗹𝘂𝗲 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗰𝗿𝗲𝗮𝘁𝗶𝗻𝗴 𝗻𝗲𝘄 𝗿𝗶𝘀𝗸𝘀 𝗳𝗼𝗿 𝘂𝘀𝗲𝗿𝘀?
As health monitoring increasingly moves to smartphones, wearables, and other general-purpose digital devices, Japan’s PMDA has outlined key review considerations for home-use Software as a Medical Device (SaMD) designed to detect signs of disease and encourage users to seek medical consultation. The guidance provides important expectations for product design, clinical evaluation, and risk management.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Clearly define the clinical intention and distinguish disease detection from diagnosis
• Specify input data, target signs, and analytical methods, including AI algorithms
• Ensure outputs are clear and non-misleading for non-expert users
• Address false-positive and false-negative risks through appropriate safeguards
• Evaluate clinical performance, software lifecycle, cybersecurity, and usability
• Clinical studies involving human subjects are generally necessary for home-use environments

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
For manufacturers entering Japan, these expectations can directly affect product development, clinical study planning, evidence requirements, and regulatory strategy. Early alignment between the product’s intended use and PMDA’s review expectations can help reduce regulatory uncertainty and avoid costly rework.

🔎 For more details, refer to the full article: https://lnkd.in/giGVJuHR

📌 Looking to bring SaMD to Japan? Qualtech can support your regulatory strategy, clinical evaluation planning, and market entry activities.

📢 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗪𝗲𝗯𝗶𝗻𝗮𝗿: 𝗝𝗮𝗽𝗮𝗻 & 𝗦𝗼𝘂𝘁𝗵 𝗞𝗼𝗿𝗲𝗮 – 𝗞𝗲𝘆 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀Looking to expand your medical ...
03/09/2026

📢 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗪𝗲𝗯𝗶𝗻𝗮𝗿: 𝗝𝗮𝗽𝗮𝗻 & 𝗦𝗼𝘂𝘁𝗵 𝗞𝗼𝗿𝗲𝗮 – 𝗞𝗲𝘆 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀
Looking to expand your medical device business into Japan or South Korea?
Join Qualtech’s upcoming webinar for a practical look at key regulatory developments shaping medical device market access in these two important Asian markets.

🎯 𝗪𝗵𝗮𝘁 𝗪𝗶𝗹𝗹 𝗕𝗲 𝗖𝗼𝘃𝗲𝗿𝗲𝗱?
🇯🇵 Japan: Leveraging existing biocompatibility reports for PMDA
🇰🇷 South Korea: Digital Healthcare Products Act & digital medical devices
💡 Practical Takeaways & Interactive Q&A

Whether you are exploring market entry or reviewing your existing regulatory strategy, this session will provide practical insights to help you navigate the evolving regulatory landscape.
📆 Date: Thursday, 17 September 2026
🕓 Time: 4:00 PM (GMT+8) | 10:00 AM (CET)
🔗 Register now: https://us02web.zoom.us/webinar/register/WN_1nXqwoSPROanr_LE6jU1Kg

Whether you are planning market entry or reviewing your regulatory strategy, this session will provide practical insights to help you move forward with confidence.

Save your seat and stay ahead of regulatory developments in Japan and South Korea.

📢 𝗖𝗼𝘂𝗹𝗱 𝗻𝗼𝗻-𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗼𝗻𝗹𝗶𝗻𝗲 𝘀𝗮𝗹𝗲𝘀 𝗽𝘂𝘁 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗮𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗶𝘀𝗸 𝗶𝗻 𝗦𝗶𝗻𝗴𝗮𝗽𝗼𝗿𝗲?Singapore's Health S...
27/08/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝗻𝗼𝗻-𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗼𝗻𝗹𝗶𝗻𝗲 𝘀𝗮𝗹𝗲𝘀 𝗽𝘂𝘁 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗮𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗶𝘀𝗸 𝗶𝗻 𝗦𝗶𝗻𝗴𝗮𝗽𝗼𝗿𝗲?
Singapore's Health Sciences Authority (HSA) has reinforced its oversight of contact lenses and other regulated health products through consumer advisories and enforcement actions. The authority reminds businesses that contact lenses are regulated medical devices that must meet registration, licensing, and distribution requirements. Recent enforcement efforts also targeted illegal online listings, underscoring HSA's continued focus on protecting public health and ensuring regulatory compliance.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Contact lenses, including cosmetic lenses, are regulated medical devices requiring professional prescription and supply.
• HSA removed 959 illegal health product listings, with over 82% involving unregistered contact lenses.
• Online sale of unregistered contact lenses is prohibited and subject to enforcement action.
• Importers and wholesalers of refractive contact lenses must hold the appropriate HSA licences and comply with Good Distribution Practice (GDP) requirements.
• Non-compliance may result in product seizures, listing removals, investigations, fines, and prosecution.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
Manufacturers, importers, distributors, and online sellers should review their regulatory obligations before supplying contact lenses or other medical devices in Singapore. Stronger market surveillance means that maintaining product registration, licensing, and distribution compliance is essential to protect market access, avoid enforcement actions, and support long-term business operations.

🔎 For more details, refer to the full article: https://lnkd.in/g63miDPV

📌 𝗡𝗲𝗲𝗱 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘄𝗶𝘁𝗵 𝗦𝗶𝗻𝗴𝗮𝗽𝗼𝗿𝗲 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲?
Qualtech Consulting Corporation provides expert assistance with HSA registration, regulatory strategy, product compliance, and market entry to help manufacturers successfully navigate Singapore's regulatory requirements.

📢 𝗪𝗶𝗹𝗹 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮'𝘀 𝗿𝗲𝘃𝗶𝘀𝗲𝗱 𝗹𝗮𝗯𝗲𝗹𝗹𝗶𝗻𝗴 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗮𝗳𝗳𝗲𝗰𝘁 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗽𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼?Malaysia's Medical Device Authorit...
25/08/2026

📢 𝗪𝗶𝗹𝗹 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮'𝘀 𝗿𝗲𝘃𝗶𝘀𝗲𝗱 𝗹𝗮𝗯𝗲𝗹𝗹𝗶𝗻𝗴 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗮𝗳𝗳𝗲𝗰𝘁 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗽𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼?
Malaysia's Medical Device Authority (MDA) has revised MDA/GD/0026: Requirements for Labelling of Medical Devices, introducing a simpler approach to foreign manufacturer contact details on medical device labels. Effective 22 May 2026, the update reduces mandatory labelling requirements while maintaining essential manufacturer identification for regulatory purposes.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Revised MDA/GD/0026 took effect on 22 May 2026.
• Foreign manufacturers are now only required to include their name and address on product labels.
• Contact details such as email address, telephone number, and website are now optional.
• Optional contact information may still be provided to support technical assistance.
• Manufacturers should review existing and future product labels to align with the updated guidance.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
Although this revision simplifies labelling requirements, manufacturers should assess their current labelling strategy to ensure ongoing compliance in the Malaysian market. Updating labels proactively can help prevent regulatory issues, streamline product registration, and support uninterrupted market access while avoiding unnecessary labelling content.

🔎 For more details, refer to the full article: https://lnkd.in/gBEYwmpx

📌 𝗡𝗲𝗲𝗱 𝗮𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲?
Qualtech Consulting Corporation provides expert support for labelling reviews, medical device registration, regulatory strategy, and market entry to help manufacturers meet Malaysia's evolving regulatory requirements.

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗽𝗼𝘀𝘁-𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗿𝗲𝗾𝘂𝗶𝗿𝗲 𝗮 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗶𝗻 𝘁𝗵𝗲 𝗣𝗵𝗶𝗹𝗶𝗽𝗽𝗶𝗻𝗲𝘀?The Philippine Food...
20/08/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗽𝗼𝘀𝘁-𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗿𝗲𝗾𝘂𝗶𝗿𝗲 𝗮 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗶𝗻 𝘁𝗵𝗲 𝗣𝗵𝗶𝗹𝗶𝗽𝗽𝗶𝗻𝗲𝘀?
The Philippine Food and Drug Administration (FDA-CDRRHR) has released a draft Circular proposing a comprehensive risk-based framework for post-approval variations for medical and health-related devices. The proposed guidelines introduce clearer variation classifications, a dedicated pathway for medical device software (MDSW), and enhanced post-market responsibilities to help standardize variation management while aligning with international regulatory principles.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Introduces a risk-based classification of Major and Minor variations.
• Establishes a dedicated variation framework for Medical Device Software (MDSW).
• Allows a single variation application for eligible multiple product authorizations.
• Updates submission procedures, including revised application limits and designated submission channels.
• Strengthens post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers, including traceability and adverse event monitoring.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
If adopted, these proposed guidelines could significantly affect how manufacturers plan and manage post-approval changes throughout a product's lifecycle. Companies should evaluate their internal change management processes, regulatory documentation, and post-market compliance strategies to prepare for the new requirements and avoid unnecessary delays in implementing product changes.

🔎 For more details, refer to the full article: https://lnkd.in/gaa2M36X

📌 𝗡𝗲𝗲𝗱 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘄𝗶𝘁𝗵 𝗣𝗵𝗶𝗹𝗶𝗽𝗽𝗶𝗻𝗲 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀?
Qualtech Consulting Corporation provides expert assistance with product registration, variation applications, regulatory strategy, Authorized Representative (AR) services, and ongoing compliance to support successful market entry and lifecycle management.

🌏 𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵 𝗶𝘀 𝗻𝗼𝘄 𝗶𝗻 𝗡𝗲𝘄 𝗭𝗲𝗮𝗹𝗮𝗻𝗱 — 𝗼𝘂𝗿 𝟭𝟱𝘁𝗵 𝗼𝗳𝗳𝗶𝗰𝗲, 𝗻𝗼𝘄 𝗼𝗽𝗲𝗻 𝗶𝗻 𝗔𝘂𝗰𝗸𝗹𝗮𝗻𝗱 We're pleased to announce the opening of our Au...
18/08/2026

🌏 𝗤𝘂𝗮𝗹𝘁𝗲𝗰𝗵 𝗶𝘀 𝗻𝗼𝘄 𝗶𝗻 𝗡𝗲𝘄 𝗭𝗲𝗮𝗹𝗮𝗻𝗱 — 𝗼𝘂𝗿 𝟭𝟱𝘁𝗵 𝗼𝗳𝗳𝗶𝗰𝗲, 𝗻𝗼𝘄 𝗼𝗽𝗲𝗻 𝗶𝗻 𝗔𝘂𝗰𝗸𝗹𝗮𝗻𝗱 We're pleased to announce the opening of our Auckland office, expanding our ability to support global medical device companies entering Asia Pacific and Oceania.

Medical devices in New Zealand are regulated by MEDSAFE. Foreign manufacturers must appoint a New Zealand-based Sponsor, and devices must be notified in the WAND database within 30 days of market entry — with the Sponsor responsible for compliance, post-market obligations, and communication with MEDSAFE.

🎯 To mark our Auckland launch, we're offering a 𝗙𝗥𝗘𝗘 𝟭-𝗵𝗼𝘂𝗿 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 for companies exploring the New Zealand market.

In this session, our regulatory experts will walk through:
• Sponsor requirements and how Qualtech can act as your local representative
• WAND notification and classification under the GHTF system
• A realistic timeline for entering the New Zealand market with your device

This is a genuine 1-on-1 session with our regulatory team, not a sales call — bring your specific product and questions.

👉 Book your free 1-hour consultation: [email protected]

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗿𝗮𝘄 𝗺𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗮𝗳𝗳𝗲𝗰𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗶𝗻 𝗝𝗮𝗽𝗮𝗻?Japan's PMDA has published a new Q&A...
14/08/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗿𝗮𝘄 𝗺𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗮𝗳𝗳𝗲𝗰𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗶𝗻 𝗝𝗮𝗽𝗮𝗻?
Japan's PMDA has published a new Q&A document to clarify the implementation of the Standards for Biological Raw Materials, providing practical guidance for manufacturers of pharmaceuticals, medical devices, and related products. The update addresses key operational issues, including donor screening, testing reliability, prion clearance evaluation, and BSE risk status, helping companies better understand regulatory expectations.

🔍𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Clarifies expectations for demonstrating the reliability of donor screening and infectious disease testing.
• Reinforces the use of validated testing methods and qualified testing facilities.
• Highlights quality management requirements, including recognized third-party laboratory accreditation (e.g., ISO 15189). • Confirms there are currently no established acceptance criteria for evaluating prion clearance values. • Explains how changes to a country's BSE risk status may affect raw material replacement requirements and regulatory documentation.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
These clarifications provide greater regulatory certainty for manufacturers using biological raw materials in products intended for the Japanese market. Companies should review their supplier qualification processes, testing strategies, quality systems, and regulatory documentation to ensure continued compliance and avoid delays in product registration or lifecycle management.

🔎 For more details, refer to the full article: https://lnkd.in/gfcFxkt5

📌 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝘁𝗼 𝗲𝗻𝘁𝗲𝗿 𝗼𝗿 𝗺𝗮𝗶𝗻𝘁𝗮𝗶𝗻 𝘁𝗵𝗲 𝗝𝗮𝗽𝗮𝗻 𝗺𝗮𝗿𝗸𝗲𝘁?
Qualtech Consulting Corporation supports medical device manufacturers with Japan regulatory strategy, product registration, compliance assessments, and ongoing regulatory support to help streamline market access.

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗮𝗲𝘀𝘁𝗵𝗲𝘁𝗶𝗰 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗻𝗼𝘄 𝗳𝗮𝗹𝗹 𝘂𝗻𝗱𝗲𝗿 𝗛𝗼𝗻𝗴 𝗞𝗼𝗻𝗴'𝘀 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀?Hong Kong has updated its Guidance ...
12/08/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝘆𝗼𝘂𝗿 𝗮𝗲𝘀𝘁𝗵𝗲𝘁𝗶𝗰 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗻𝗼𝘄 𝗳𝗮𝗹𝗹 𝘂𝗻𝗱𝗲𝗿 𝗛𝗼𝗻𝗴 𝗞𝗼𝗻𝗴'𝘀 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀?
Hong Kong has updated its Guidance Notes for Definitions and Abbreviations for the Medical Device Administrative Control System (GN-00), introducing Appendix 1 to formally designate specific products as medical devices under MDACS. The first category added is injectable dermal and mucous membrane fillers, reflecting increased regulatory oversight of higher-risk aesthetic products.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• New Appendix 1 introduced under GN-00, effective 13 May 2026.
• Injectable dermal and mucous membrane fillers are now classified as medical devices under MDACS.
• The definition of medical devices has been expanded to include products listed in Appendix 1.
• Manufacturers should reassess product classifications, labeling, intended use, and technical documentation.
• Local Responsible Persons (LRPs) are expected to strengthen regulatory surveillance and registration planning.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
This update may directly affect market access strategies for manufacturers of aesthetic products entering Hong Kong. Companies should review their product portfolios early to identify newly regulated products, evaluate compliance obligations, and prepare for potential registration requirements. Staying ahead of regulatory changes can help minimize business disruption and support long-term market expansion.

🔎 For more details, refer to the full article: https://lnkd.in/gXkuhq5X

📌 𝗡𝗲𝗲𝗱 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗻𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗛𝗼𝗻𝗴 𝗞𝗼𝗻𝗴 𝗠𝗗𝗔𝗖𝗦 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀?
Qualtech Consulting Corporation can assist with product classification, registration planning, Local Responsible Person (LRP) services, and regulatory compliance to help you enter the Hong Kong market with confidence.

📢 𝗖𝗼𝘂𝗹𝗱 𝗮 𝗷𝗼𝗶𝗻𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗮𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗲 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗺𝗮𝗿𝗸𝗲𝘁 𝗲𝗻𝘁𝗿𝘆 𝗶𝗻𝘁𝗼 𝗯𝗼𝘁𝗵 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗮𝗻𝗱 𝗖𝗵𝗶𝗻𝗮?The Malaysia...
10/08/2026

📢 𝗖𝗼𝘂𝗹𝗱 𝗮 𝗷𝗼𝗶𝗻𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗮𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗲 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗺𝗮𝗿𝗸𝗲𝘁 𝗲𝗻𝘁𝗿𝘆 𝗶𝗻𝘁𝗼 𝗯𝗼𝘁𝗵 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗮𝗻𝗱 𝗖𝗵𝗶𝗻𝗮?
The Malaysia Medical Device Authority (MDA) has launched Phase 2 of the Malaysia–China Joint Evaluation Pilot Programme, running from 1 July to 30 September 2026. Developed in collaboration with China's National Medical Products Administration (NMPA) under the GHWP Common Evaluation Reliance Practice (CERP), the programme enables eligible medical device applications to undergo a collaborative evaluation, helping reduce duplicated assessments and improve regulatory efficiency.

🔍 𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀
• Phase 2 is open from 1 July to 30 September 2026.
• Eligible applications can be jointly evaluated by Malaysia MDA and China NMPA.
• The programme aims to streamline registration and minimize duplicate regulatory assessments.
• Participation is limited to eligible local manufacturers that own and operate manufacturing facilities.
• Applicants must meet programme eligibility requirements and submit complete premarket documentation before evaluation.

⚠️ 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀
For eligible manufacturers, this pilot programme presents an opportunity to optimize registration planning for both Malaysia and China through a coordinated regulatory approach. Understanding the eligibility criteria, documentation requirements, and submission process early can help reduce regulatory complexity, improve operational efficiency, and support faster access to two key Asia-Pacific markets.

🔎 For more details, refer to the full article: https://lnkd.in/gnQA4c-d

📌 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗲𝘅𝗽𝗮𝗻𝗱𝗶𝗻𝗴 𝗶𝗻𝘁𝗼 𝗠𝗮𝗹𝗮𝘆𝘀𝗶𝗮 𝗮𝗻𝗱 𝗖𝗵𝗶𝗻𝗮?
Qualtech Consulting Corporation can help assess programme eligibility, prepare regulatory documentation, and support your medical device registration strategy in both markets.

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