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Regulatory Compliance and Clinical Trial Services across 50 Countries & Regions.

16

16 wholly-owned subsidiaries worldwide.

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Trusted Partner to 600+ Leading Enterprises.

3000

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Over 3,000 Successful Registrations & Certificates Issued.

Global Self-operated Matrix

With 16 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

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.

Medical Device Labeling in Canada: Interpretation of 10 Mandatory Label Items & Bilingual Requirements

This article interprets the 10 mandatory labeling items and bilingual requirements for medical devices in Canada, including device name, manufacturer information, device identifier, control number, description of package contents, sterility marking, expiry date, intended use and performance specifications, instructions for use, and special storage conditions. It also introduces remedial solutions for non-compliant labels, and highlights the importance of labeling compliance for product customs clearance and market launch.

Understanding MDCG 2020‑16 rev.2 | Core Guidance on IVD Product Classification under EU IVDR

This article interprets MDCG 2020‑16 rev.2, the core guidance on classification under the EU IVDR. It elaborates on the significance of product classification for CE compliance following the entry into force of IVDR. Classification is determined by the product’s intended use rather than the detection technology. It also details the classification rules, risk classes and the assessment approach for combined kits and associated products. While the guidance is not legally binding, it serves as an important reference for manufacturers to conduct classification determination and compile classification justification documents.

Must-Know Guide: UKCA Marking for Medical Devices in 2026 – Key FAQs & Essentials

FDA Update! 14 Classes of Class II Toxicology Testing Systems Qualify for 510(k) Exemption!

On October 6, 2026, the FDA issued a final rule expanding the 510(k) exemption scope for 14 types of Class II drug abuse testing systems. These systems may qualify for the exemption even when used in federal drug testing programs, subject to strict constraints including intended use limitations and labeling statements.

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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Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.