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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.

What Should You Know About Import Notification of Medical Devices in South Korea? What Information Needs to Be Filled In?

This article introduces relevant information about the import notification certificate for medical devices in South Korea, with a specific focus on the filing procedures and key considerations for Class I medical devices. It elaborates on the distinctions between the three major types of regulatory documents for South Korean medical devices: notification certificates, certification certificates and approval licenses. Class I medical devices fall under the notification system, as they carry the lowest risk. Enterprises may obtain a notification certificate simply by submitting the required documentation. The article further breaks down each key section of the notification certificate in detail, including the top selection panel, product names, models, classification codes, and manufacturer/importer particulars. It reminds enterprises to double-check product models and classification codes during filing to prevent issues during customs clearance.

What Does a Colombia INVIMA Certificate Look Like? What Information Does It Contain?

The INVIMA Sanitary Registration Certificate is the sole legal permit for products to enter the Colombian market. Issued by INVIMA, it covers the registration approval, post-market sampling inspection, and adverse event surveillance of both medical devices and in vitro diagnostic reagents. The legal validity of the certificate derives from three core foundational decrees: the regulation governing the classification and registration of general medical devices, the separate regulatory decree for the classification of in vitro diagnostic reagents, and the statute governing market supervision as well as registration amendments. All certificates adopt a uniform appearance and format regardless of risk class; risk grades are only indicated in the product information section.

WHO Releases First Global tWLA List for Medical Devices; China’s NMPA Included!

In July 2026, the World Health Organization (WHO) released its inaugural List of Transitional WHO Listed Authorities for Medical Devices (tWLAs-MD), marking the launch of a new standardized evaluation framework for global medical device regulation. The National Medical Products Administration of China (NMPA) has been successfully included in the list, ranking among the world’s only 12 top-tier regulatory authorities. This list is designed to address the lack of unified regulatory standards in the medical device sector, facilitate global regulatory cooperation, and boost the international recognition of domestic registration certificates. The transitional list is valid for five years. During this period, the WHO will dynamically assess the regulatory capacity of each authority, with eligible bodies to be upgraded to permanent WLA status. The WHO emphasizes that mutual trust and collaboration among regulators will optimize resource allocation and accelerate global access to safe and effective medical devices.

Why Do Class I/II Brazilian Medical Devices Have No Physical Certificates, While Class III/IV Do?

This article discusses the distinct regulatory regimes for medical device registration in Brazil, focusing specifically on the differences between Class I/II and Class III/IV devices. Low- and medium-risk Class I and II devices are not issued standalone paper or electronic registration certificates; printed copies of official web inquiry records serve as the sole compliance proof. In contrast, high-risk Class III and IV devices receive formal PDF registration certificates bearing Brazil’s national emblem and official agency stamps. The article conducts a detailed breakdown of all data fields displayed on the ANVISA public inquiry page for a Brazilian Class II medical device. It also stresses that overseas manufacturers are legally required to appoint a locally incorporated Brazilian legal entity as the notification holder to maintain regulatory compliance and prevent customs detention of shipments.

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