Qualtech: Medical Device Consulting

Product Registration, Clinical Trials, Local Representative, and Regulatory Services

Qualtech Consulting Corporation, founded in 2000 by Dr. Yin-Pen Chang, is a regulatory consulting service and clinical trial (CRO) company for medical devices. Operating with a cross-disciplinary team of professionals, integrity, diversity, continuous learning, and teamwork, Qualtech provides clients with effective one-stop solutions.
We have helped over 1,000 clients to gain market access in their desired locations and passed more than 5,000 medical device licenses with precision.

Qualtech News

2026-05-27

SINGAPORE: SINGAPORE & JAPAN DEEPEN COLLABORATION THROUGH RELIANCE MECHANISMS TO ENHANCE ACCESS TO HEALTH PRODUCTS – April/May 2026

On 20 April 2026, Singapore's Health Sciences Authority (HSA) and Japan's Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation (MOC) in Tokyo to enhance bilateral regulatory collaboration. The press release (issued on 21 April 2026) notes that the MOC aims to promote reliance for health products, establish mutual reliance for Good Manufacturing Practice (GMP) inspections, and support information exchange on emerging technologies.

2026-05-27

MALAYSIA: MDA Regulatory Updates - Publication of Third Edition Guidance on Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application – April/May 2026

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

2026-05-27

Philippines: Effectivity of the Implementing Guidelines for the Post-Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD) – April/May 2026

Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.

2026-05-26

Thailand: Why is Thailand's Medical Device Industry a Magnet for Investors? – April/May 2026

Thailand's medical device industry is rapidly emerging as a prime destination for global investors, driven by strong local and regional demand, government support, and a robust regulatory framework. The sector’s growth is fueled by an aging population, increasing prevalence of non-communicable diseases, and a rebound in medical tourism. These factors, combined with Thailand's abundant raw materials and institutional support, position the country as a leading hub for medical device innovation and production.

Qualtech Your best choice

Medical Device Registration

Having 20 years of regulatory registration experience, we offer product registration services in 10 Asian countries. Moreover, we set up the sales center in Japan, United State and Europe to provide direct customer service.

Clinical Trials

We provide a full range of services including clinical trials, clinical evaluation reports and post-marketing clinical follow-up. We are the first company to implement and pass the GCP by Taiwan FDA. We have also passed many GCP in China.

Authorized Representative

We can act as a local product license manager at the manufacturing facility. Help you with such activities as regulations and post-marketing tracking, and provide immediate regulatory updates.

Qualtech Solution

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Obtain Market Access via CER

Product Registration, Clinical Trials, Local Representative, and Regulatory Services

Qualtech News

SINGAPORE: SINGAPORE & JAPAN DEEPEN COLLABORATION THROUGH RELIANCE MECHANISMS TO ENHANCE ACCESS TO HEALTH PRODUCTS – April/May 2026

MALAYSIA: MDA Regulatory Updates - Publication of Third Edition Guidance on Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application – April/May 2026

Philippines: Effectivity of the Implementing Guidelines for the Post-Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD) – April/May 2026

Thailand: Why is Thailand's Medical Device Industry a Magnet for Investors? – April/May 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy