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.

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Qualtech News

South Korea: Recent MFDS Regulatory Updates – Medical Device Adverse Event Reporting and KGMP – September/October 2026
2026-10-26

South Korea: Recent MFDS Regulatory Updates – Medical Device Adverse Event Reporting and KGMP – September/October 2026

The Ministry of Food and Drug Safety (MFDS) of South Korea has recently revised regulations concerning medical device adverse event reporting and Korean Good Manufacturing Practice (KGMP) and introduced a new regulation governing the designation and management of organizations involved in medical device quality management.
These regulatory updates aim to clarify adverse event reporting requirements and timelines, while improving regulatory clarity by separating KGMP conformity assessment requirements from provisions governing assessment bodies and training organizations.
This newsletter provides an overview of three regulatory updates that took effect on July 1 and September 22, 2026.

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2026-10-26

Japan: A Brief Introduction to SaMD Application: FAQ – September/October 2026

This FAQ summarizes key regulatory resources and consultation opportunities relevant to the development and regulatory submission of Software as a Medical Device (SaMD) in Japan. The information is intended to support manufacturers in understanding regulatory expectations and planning efficient development and submission strategies throughout the product lifecycle.

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2026-10-26

Australia: TGA Updates Application Audit Selection Criteria with a Focus on Gynaecological Curettes – September/October 2026

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.

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2026-10-09

Qualtech Webinar: ASEAN Regulatory Briefing – Thailand & Malaysia – October 2026

Qualtech invites you to our free webinar on Thursday, October 29, 2026, with the topic "ASEAN Regulatory Briefing: Thailand & Malaysia - Critical Updates Impacting Medical Device Market Access".
Our local regulatory experts from Thailand and Malaysia will share practical insights into the latest regulatory changes, updated requirements, and key considerations affecting medical device registration and regulatory compliance. This session is highly recommended for all medical device manufacturers currently active in, or planning to enter, the Thailand and Malaysian market.

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Qualtech Your best choice

Qualtech | 理工科技
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.

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Qualtech | 理工科技
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.

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Qualtech | 理工科技
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.

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Qualtech Solution

Multi-country Submission

Multi-country Submission

Qualtech provides you with multi-country registration solutions. What you need to do is only to contact a single window and prepare a set of documents.

One-Stop Registration

One-Stop Registration

Qualtech conducts clinical trials based on registered experience, which meets the needs of local health authorities; We are familiar with clinical trial requirements in the Asian market.

Market Access Strategy

Market Access Strategy

Qualtech can provide you with multi-regional regulatory research, market research, product standard assessment and competitive product search services

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