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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.

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

澳洲皇家化学协会成员，具有医疗设备、药品、代工生产和补充药品领域的指导经验，精通ISO13485/14791标准

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.

Turkey: The Golden Eurasian Gateway – Practical Guide to Medical Device Registration

Turkey acts as a vital springboard for Chinese medical device manufacturers to access the Middle Eastern and European markets. While many companies assume that holding an EU CE certificate qualifies them to sell products in Turkey, they must in fact comply with unique local market access requirements. Combining Turkey’s 2026 Medical Device Regulation (TMDr), this article elaborates on the full registration procedure for medical devices in Turkey, enabling domestic manufacturers to enter the Turkish market smoothly. This paper outlines Turkey’s regulatory framework, covering the respective mandates of TITCK and SGK, as well as transition policies stipulated under the local TMDr regulation. It further explains the product risk classification system fully aligned with EU standards, which directly impacts review timelines, registration expenses and the complexity of SUT Code applications.

How Cost-Effective Is Malaysia’s Mutual Recognition Route? A One-Stop Solution to Enter Singapore, Malaysia & Thailand

This article introduces the medical device regulatory mutual recognition mechanisms between Malaysia, Singapore and Thailand, all of which officially take effect in 2026. Through these mutual recognition pathways, enterprises can fast-track medical device registration across Singapore, Malaysia and Thailand, with approval cycles cut in half and compliance costs significantly reduced. Under the mutual recognition frameworks, registration and test data completed in one jurisdiction can be directly adopted in the other, eliminating redundant trials and assessments and greatly streamlining registration procedures. This delivers remarkable convenience and cost advantages for domestic medical device manufacturers seeking access to the ASEAN market.

How to Enter the Middle East Blue Ocean? A Complete Guide to Saudi Medical Device Registration

This article provides a detailed overview of the core 要点 of Saudi medical device registration, helping enterprises understand the access logic of the largest medical market in the Middle East. The Saudi Food and Drug Administration (SFDA) classifies medical devices and in vitro diagnostic reagents into four categories based on risk levels, and regulates them in accordance with the Medical Devices Law and its Implementing Regulation. The registration process includes appointing a Saudi Authorized Representative (AR), preparing technical documentation, submitting the application, paying official fees, responding to inquiries, and obtaining the marketing authorization certificate. The technical documentation requirements are similar to those of the EU MDR, requiring detailed device descriptions, risk management files, clinical investigation reports, and more.

High-Risk Aesthetic Medical Device Market Access in Southeast Asia (Part 2): A Guide to Accelerating Compliance Registration in Malaysia and Vietnam

This article continues to examine the registration rules for aesthetic medical devices in Malaysia and Vietnam, two key Southeast Asian markets. Malaysia has a mature regulatory system with stringent requirements for technical documentation and post-market systems. Products holding EU CE marking or US FDA certification may apply for a simplified review pathway. Vietnam features a relatively streamlined registration process, while close attention shall be paid to classification determination and document consistency. High-risk products in Malaysia are required to establish a post-market surveillance (PMS) system and submit the corresponding procedural documents. Vietnam’s registration framework is aligned with the ASEAN Medical Device Directive (AMDD), and the risk classification of products must be conducted in strict compliance with official classification rules.

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