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15 wholly-owned subsidiaries worldwide.

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Trusted Partner to 600+ Leading Enterprises.

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Over 3,000 Successful Registrations & Certificates Issued.

Global Self-operated Matrix

With 15 global wholly-owned subsidiaries, WISELINK GROUP adheres to “Originated in Australia, Rooted in China, Serving the World”, providing global compliance and clinical trial services for healthcare and consumer product manufacturers.

Australia (Headquarters)

Australia (Headquarters)

Hong Kong, China

Hong Kong, China

Compliance Certification Expertise

Dr. Derrick Beech

Dr. Derrick Beech

WISELINK INDEPENDENT CONSULTANT. Former Head of the Therapeutic Goods Administration (TGA) in Australia. Honorary Senior Lecturer in the Department of Oral Sciences at the University of Melbourne. Visiting Professor at the University of Sydney in Australia. Lecturer at the University of Manchester in the UK.

Masayuki KAWAHARA

Masayuki KAWAHARA

Consultant of Wiselink Japan Co., Ltd., Core Member of HBD in the PMDA-FDA Joint Project

PROJECT DIRECTOR. Bachelor of Medicine from the Faculty of Medicine at the University of Sydney. ISO 13485 System Auditor Expert.

Konstantinos T. Makarounis

Konstantinos T. Makarounis

DR. MEDICINE, UNIVERSITY OF ATHENS. Male Fertility Microsurgery at Cornell University in New York, USA. Member of the European Association of Sexual Medicine.

Despina Kaliontz

Despina Kaliontz

CLINICAL HEMATOLOGIST. Expert in Malignant Hematological Diseases. Specialist in Peripheral Blood Stem Cell Harvesting for Transplantation. Researcher in Gene Expression of Acute Myeloid Leukemia Patients.

CLINICAL HEMATOLOGIST. Expert in Malignant Hematological Diseases. Specialist in Peripheral Blood Stem Cell Harvesting for Transplantation. Researcher in Gene Expression of Acute Myeloid Leukemia Patients.

Registered Regulatory Expert, ISO Quality Management System Auditor

Vasilis Tsilivakos

Vasilis Tsilivakos

Expert in cell biology and immunology, mainly researching HIV infection and treatment

Giovanna Casamassa

Giovanna Casamassa

Microbiology Laboratory Manager, ISO 13485 System Audit Expert, 17025:2018 - Laboratory Quality Audit Expert

Global Regulatory Tracking

With timeliness, accuracy and practicality at its core, WISELINK offers regulatory updates, interpretations and trend analysis to help businesses navigate global compliance and drive global growth.

FDA Updates Recognized Consensus Standards List, Covering Dental, Cardiovascular, Orthopedic and Other Sectors

On August 24, 2026, the U.S. FDA issued Recognition List No. 066, amending the list of voluntary consensus standards recognized for premarket review of medical devices. This update covers more than ten fields including biocompatibility, cardiovascular devices, dentistry, orthopedics and medical software, involving the addition, replacement and withdrawal of standards as well as transition‑period adjustments. All changes take effect on the date of publication.

Which Medical Devices Require South‑Korea KC Certification? What Is KC Certification?

This article introduces the scope of application, certification types and procedures of South Korea’s KC certification. It highlights the differences between KC certification and MFDS registration, and points out the common misunderstandings about KC certification held by some medical‑device enterprises. It also elaborates on the regulatory authority, product classification and requirements of different certification modes for KC certification.

Takes Effect on September 11! Mandatory Reporting Under EU CRA: Fines Up to 2.5% of Global Turnover

The mandatory vulnerability and security‑incident reporting obligations under the EU Cyber Resilience Act (CRA) will enter into force on 11 September 2026, applying to all products with digital elements placed on the EU market, including legacy products already in circulation. Reporting responsibilities rest with manufacturers, importers, distributors and open‑source software maintainers. Mandatory reporting is triggered only when vulnerabilities are maliciously exploited or severe security incidents occur.

Australia’s TGA Recognises Extended EU MDR Transition Periods, Deadlines up to End‑2028

In its official announcement, Australia’s TGA fully recognises the extended transition policy under the EU MDR, granting medical‑device manufacturers a longer compliance buffer and enabling smoother alignment for market‑access procedures. Devices of different risk classes are subject to staggered transition deadlines, with the latest falling in 2028.

Regular Q&A

Can medical device products undergo registration changes after completing registration?

Can a product be registered by multiple Sponsors at the same time?

Can the Sponsor be replaced if the Sponsor is uncooperative in business operations after a medical device has completed registration?

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