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

2026-09-21

China's Bariatric and Metabolic Surgery Market: Demand, Policy and Device Trends – August/September 2026

China's obesity burden continues to rise, with about 57% of adults overweight / obese and the rate projected to reach 70.5% by 2030. At the same time, nearly 970 hospitals are estimated to be involved in bariatric and metabolic surgery nationwide, while China's bariatric surgery market is projected to grow from US$207M in 2026 to nearly US$398M by 2031. This article reviews the latest policy, clinical and market developments shaping opportunities in China's obesity-treatment and minimally invasive surgery sectors.

2026-09-21

Singapore: Healthcare Regulatory and Enforcement Functions to Move From MOH to HSA – August/September 2026

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

2026-09-21

Singapore: HSA Allows Concurrent Processing of Up to Two Change Notification Applications for the Same Medical Device Listing – August/September 2026

Singapore's Health Sciences Authority (HSA) has enhanced its Change Notification (CN) process for registered medical devices. With immediate effect, up to two CN applications may now be processed concurrently for the same medical device listing, providing greater flexibility for stakeholders in managing regulatory changes and facilitating more timely implementation of device updates.

2026-09-21

Philippines: An Overview of the Proposed FDA Guidelines on Good Manufacturing Practices (GMP) for Medical Devices – August/September 2026

The Philippine Department of Health has released a proposed Administrative Order establishing Good Manufacturing Practice (GMP) guidelines for local medical device and IVD medical device manufacturers. The proposed Order adopts PNS ISO 13485:2019 as the Food and Drug Administration (FDA)'s official GMP guideline and applicable PNS ISO 14644 standards for clean rooms. A two-year transitory period is proposed to allow affected manufacturers to comply with the new requirements once the Order takes effect.

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

Qualtech News

China's Bariatric and Metabolic Surgery Market: Demand, Policy and Device Trends – August/September 2026

Singapore: Healthcare Regulatory and Enforcement Functions to Move From MOH to HSA – August/September 2026

Singapore: HSA Allows Concurrent Processing of Up to Two Change Notification Applications for the Same Medical Device Listing – August/September 2026

Philippines: An Overview of the Proposed FDA Guidelines on Good Manufacturing Practices (GMP) for Medical Devices – August/September 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy