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

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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

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.

EU COMBINE P2 Guideline Released: Harmonisation & Simplification for Safety Reporting in Combined Medicinal‑Device Studies

The EU has released the COMBINE P2 Guideline, which aims to harmonise the safety event reporting procedures for combined medicinal-device clinical studies. The guidance addresses inconsistencies across the three regulatory frameworks — CTR, MDR and IVDR — concerning SAE definitions, reporting timelines and submission channels, helping enterprises cut compliance costs.

Major New Regulations for Hong Kong Aesthetic Medicine! Mandatory Listing for Injectable Products!

The Department of Health of Hong Kong released new regulations in September 2026, introducing unified compliance standards for injectable and infusible aesthetic medical products. Mandatory listing of such products in the medical device register will take effect on 1 March 2027. Covering three categories, namely pharmaceutical products, human organ/tissue products and medical devices, the new rules require licensed private healthcare facilities to strictly abide by relevant ordinances, and unauthorised use of non-compliant products shall be prohibited.

MDCG 2020‑16 rev.5 Released! Decoding IVD Classification Rules under IVDR

The Medical Device Coordination Group (MDCG) has published MDCG 2020‑16 rev.5, the core guidance document for Regulation (EU) 2017/746 (IVDR). This article provides a detailed interpretation of the classification rules for in‑vitro diagnostic medical devices under IVDR, covering the four risk classes (Class A‑D), with focused analysis on the classification rationale for control materials under Rule 7. It also highlights the importance for manufacturers to clearly define the intended purpose within technical documentation. Where a product may foreseeably be used in higher‑risk scenarios, usage limitations shall be specified in the instructions for use. In addition, it elaborates on the classification of special product types including software, combined kits, calibrators and quality‑control materials.

Australia's TGA Adds New Class IIa Classification Rule! CDSS Exemption Provisions Updated Simultaneously

Australia's Therapeutic Goods Administration (TGA) has amended Part 2 of Schedule 2 to the Therapeutic Goods (Medical Devices) Regulations 2002, adding a new Class IIa classification rule. The amendment explicitly classifies non-invasive devices that contain only saline and are used to flush or maintain the patency of other devices as Class IIa. Simultaneously, the exemption provisions for Clinical Decision Support Systems (CDSS) have been updated, taking effect on November 1, 2026. The new regulations establish a transition period for both new applications and existing products. Companies must carefully distinguish between pure saline products and drug-containing combination devices to avoid classification errors.

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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