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15 wholly-owned subsidiaries worldwide.

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Trusted Partner to 600+ Leading Enterprises.

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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)

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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.

Attention: FDA Reclassifies 8 Class III Medical Devices to Class II in 2026!

The FDA has recently updated the reclassification list published by the Center for Devices and Radiological Health (CDRH), announcing that eight Class III medical devices have been downgraded to Class II as of August 2026. Implemented under the reclassification mechanism, this adjustment aims to lower market‑entry barriers for products previously categorized as high‑risk. Pursuant to the Federal Food, Drug, and Cosmetic Act, there are three statutory procedures for medical‑device reclassification. Among them, Section 513(e) represents the most frequently used pathway, which applies to mature device types with existing classifications. This pathway requires new scientific evidence demonstrating a mismatch between the current classification and the product’s actual risk profile to determine whether the device’s regulatory classification should be revised.

Decoding Canada MDL Certificates: What Qualifications Do You Need to Export Medical Devices to Canada?

This article provides a detailed analysis of the structure of Canada’s Medical Device Licence (MDL) and relevant regulatory knowledge. MDL certificates feature bilingual English-French formatting and apply to Class II, III and IV medical devices; Class I devices are not issued this certificate. Key fields on the licence include the Licence Number and First Issue Date, among others. The Licence Number serves as the unique identifier for the product, which can be used to check the licence status and product information via Canada’s official database. The First Issue Date records when the product first obtained market access approval, and it does not represent the certificate’s expiry date.

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.

Regular Q&A

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

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