Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Home

About Us

Company Profile

Global Self-operated Matrix

Expert Teams

Join Us

Service

Medical Device

Health Food

Cosmetics

Foods

Value-added

Successful Cases

News Center

Q&A

Contact US

Global Compliance
One-Stop Service

Medical Device

Health Food

Cosmetics

Foods

Value-added

Europe

Asia-Pacific

North America

Middle East

Africa

Southeast Asia

South America

Asia-Pacific

North America

Southeast Asia

Europe

Asia-Pacific

North America

Southeast Asia

South America

Asia-Pacific

North America

Southeast Asia

Clinical Trial

Overseas Clinical Trial Services Australian Clinical Trial Services IVD Clinical Trial Services Clinical Trials

System Guidance

Brazil BGMP MDSAP ISO 13485

Other Services

Apostille Certification Free Sales Certificate Professional Translation Agent Services

Help Enterprises Reach Target Markets Faster

50

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

16

16 wholly-owned subsidiaries worldwide.

600

+

Trusted Partner to 600+ Leading Enterprises.

3000

+

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.

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.

EU CE: Multiple Core Standards Updated in 2026, Immediate Self-Review Required for MDR Technical Documentation

As the implementation of EU MDR (Regulation (EU) 2017/745) continues to advance, harmonised standards and industry‑wide technical benchmarks are evolving rapidly. Recent major updates to CE‑related regulatory documents cover full‑scope files including quality management, risk management, usability engineering, clinical investigations, biocompatibility, labelling and instructions for use, MDCG/MEDDEV guidance documents, and EU legislations. Newly‑revised standards such as ISO 14155:2026, ISO 10993‑3/6/7:2026 and ISO 2859‑1:2026 will have a direct impact on manufacturers’ quality management systems, test protocols, clinical investigations and technical documentation drafting. They merit close attention from all medical device enterprises that are planning for or undergoing CE certification.

Australia’s TGA Releases Full‑Scale UDI Guidance for Healthcare！

Australia’s TGA has released the comprehensive UDI overview guidance, aiming to establish a Unique Device Identification system for medical devices. The system enables end‑to‑end traceability of medical devices via globally harmonised coding and improves patient safety. It consists of two components: UDI‑DI and UDI‑PI, and recognises three issuing agencies: GS1, HIBCC and ICCBBA.

A Complete Guide to Canada Medical Device Application Types (Part 1): Detailed Rules for Determining Single/Family/Group/System

This article provides a detailed analysis of the criteria for determining application types (Single / Family / Group / System) in Canadian medical device registration, highlighting their significance for the scope of submission documentation, model selection, and clinical evidence coverage. It clarifies that application type and device classification are concepts on different dimensions. Proper determination enables overseas manufacturers to establish a reusable assessment framework.

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?

Contact Us

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.