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Help Enterprises Reach Target Markets Faster

40

Regulatory Compliance and Clinical Trial Services across 40 Countries & Regions.

15

15 wholly-owned subsidiaries worldwide.

600

+

Trusted Partner to 600+ Leading Enterprises.

3000

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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.

Meet Ziyanlan! Medical Aesthetics Overseas Expansion · New Territory Leadership Seminar to Kick Off Tomorrow

The 9th Ziyanlan International Anti-Aging Medical Aesthetics Conference will be held at Shenzhen Convention & Exhibition Center (Futian) from July 17 to 19, 2026. A dedicated strategic session themed Medical Aesthetics Global Expansion · Pioneering New Frontiers has been arranged, focusing on three high-potential markets: Southeast Asia, the Middle East and the CIS. As an invited keynote speaker, Wiselink will share hands-on experience in global regulatory compliance, delivering comprehensive actionable solutions covering compliance market access, channel development and localised operation, to help industry participants remove obstacles on their overseas expansion journey. Drawing on market insights and supply chain development strategies, the conference aims to empower Chinese medical aesthetics and medical device enterprises to capture market opportunities worldwide.

FDA Small Business Fee Waivers! Full Application Guide for FY2026

This article introduces the Small Business Determination (SBD) Program offered by the U.S. Food and Drug Administration (FDA) for medical device companies. This program aims to provide fee reductions or even full fee waivers to enterprises that meet the revenue criteria. Companies are required to submit a Small Business Request (SBR) application; upon approval, they become eligible for discounted medical device submission user fees. Enterprises qualify for different tiers of fee benefits based on the combined gross revenue of the applicant and all its affiliated entities in the most recent tax year. Companies with annual combined revenue not exceeding $100 million are entitled to reduced fees for a wide range of submissions. Those with annual combined revenue of no more than $30 million can access the same reduced fees, plus a full waiver for their first premarket submission or report.

Chile’s 2026 Mandatory Medical Device Registration Regulation Takes Effect! 39 Product Categories Brought Under Regulation

On 19 March 2026, Chile issued Decree No. 25 to expand the scope of mandatory sanitary controls for medical devices and in vitro diagnostic products (IVDs). Multiple categories of high-risk equipment are brought into the mandatory registration system administered by the Instituto de Salud Pública de Chile (ISP). Formulated pursuant to Article 111 of the Sanitary Code and Supreme Decree No. 825 of 1998 governing medical devices, the decree mandates all domestic manufacturers, importers and distributors to complete compliance verification. Chile implements risk-based classification supervision with priority oversight for high-risk equipment. ISP serves as the sole authority responsible for registration, technical review and market surveillance. Products subject to mandatory registration include in vitro diagnostic reagents, extremely high-risk implantable devices and high-risk diagnostic and therapeutic equipment.

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.

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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