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

2026-08-25

INDONESIA: New Requirements for Licensing Imported In Vitro Diagnostic (IVD) Instruments and Software Medical Devices in Indonesia – July/August 2026

Indonesia's medical device regulatory framework places increasing emphasis on demonstrating compliance with applicable healthcare standards through appropriate testing and validation. Manufacturers and applicants should ensure that the required test results, validation documents, and supporting certifications are available as part of the product registration and compliance process. Recent requirements highlighted for in vitro diagnostic products (IVDs) include specific provisions for performance testing, instrument connectivity, and software validation.

2026-08-25

HONG KONG: Hong Kong Launches "Novo Lane" for Fast-Track Approval of Innovative Medical Devices – July/August 2026

The Hong Kong Department of Health (DH), through its Medical Device Division (MDD), has established the "Novo Lane" under the Medical Device Administrative Control System (MDACS) to prioritize the processing of eligible innovative medical device listing applications. The initiative is intended to facilitate earlier access to innovative medical technologies while maintaining regulatory oversight of medical device safety and performance. As part of its regulatory approach, the MDD continues to monitor the safety and performance of listed medical devices after they are placed on the market.

2026-08-25

HONG KONG: GUIDANCE UPDATED ON CHANGE APPLICATION FOR LISTED MEDICAL DEVICES (GN-10) – July/August 2026

Hong Kong's Medical Device Division (MDD) has revised the Guidance Notes for Changes of Listed Medical Devices (GN-10), effective 26 June 2026. The update introduces new non-reportable change categories, revised major change criteria, conditional approval outcomes, and additional compliance requirements. Manufacturers and LRPs should review the revised requirements to ensure compliance under MDACS.

2026-08-25

Australia: Cataract Surgery Market – Scale, Demand and Entry Considerations for Ophthalmic Devices – July/August 2026

Australian Institute of Health and Welfare (AIHW) recorded 323,497 elective lens-intervention admissions in 2024-25, with private hospitals accounting for 71.9% of recorded activity. With 98% of cataract surgeries delivered as same-day procedures and US$121.9M of ophthalmic instrument imports in 2025, the market combines substantial procedure activity with an established international supply channel. For global manufacturers, successful entry requires product-specific ARTG, sponsorship and UDI planning.

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

INDONESIA: New Requirements for Licensing Imported In Vitro Diagnostic (IVD) Instruments and Software Medical Devices in Indonesia – July/August 2026

HONG KONG: Hong Kong Launches "Novo Lane" for Fast-Track Approval of Innovative Medical Devices – July/August 2026

HONG KONG: GUIDANCE UPDATED ON CHANGE APPLICATION FOR LISTED MEDICAL DEVICES (GN-10) – July/August 2026

Australia: Cataract Surgery Market – Scale, Demand and Entry Considerations for Ophthalmic Devices – July/August 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy