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WISELINK GROUP A total of 15 wholly-owned subsidiaries have been established worldwide.
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Service
Medical Device
Health Food
Cosmetics
Foods
Value-added
Europe
EU(CE)
EU(CE)
UK(UKCA)
UK(UKCA)
CH(SWISSMEDIC)
CH(SWISSMEDIC)
SRB(ALIMS)
SRB(ALIMS)
IT(AIFA)
IT(AIFA)
ES(AEMPS)
ES(AEMPS)
Asia-Pacific
AU(TGA)
AU(TGA)
JP(PMDA)
JP(PMDA)
CN HK(MDACS)
CN HK(MDACS)
KP(MFDS)
KP(MFDS)
NZ(MEDSAFE)
NZ(MEDSAFE)
CN TW(TFDA)
CN TW(TFDA)
PK(DRAP)
PK(DRAP)
UZ(MOH)
UZ(MOH)
BD(DGDA)
BD(DGDA)
CN(NMPA)
CN(NMPA)
IN(CDSCO)
IN(CDSCO)
KZ(FMXM)
KZ(FMXM)
North America
US(FDA)
US(FDA)
US(DMF)
US(DMF)
CA(HC)
CA(HC)
MX(COFEPRIS)
MX(COFEPRIS)
Middle East
SA(SFDA)
SA(SFDA)
UAE(MOHAP)
UAE(MOHAP)
EG(EDA)
EG(EDA)
TR(TITCK)
TR(TITCK)
Africa
NG(NAFDAC)
NG(NAFDAC)
KEN(PPB)
KEN(PPB)
ET(EFDA)
ET(EFDA)
Southeast Asia
TH(TFDA)
TH(TFDA)
SG(HSA)
SG(HSA)
VN(MOH)
VN(MOH)
ID(MOH)
ID(MOH)
MY(MDA)
MY(MDA)
PH(PFDA)
PH(PFDA)
South America
BR(ANVISA)
BR(ANVISA)
PE(DIGEMID)
PE(DIGEMID)
EC(ARCSA)
EC(ARCSA)
CO(INVIMA)
CO(INVIMA)
CL(ANDID)
CL(ANDID)
AR(ANMAT)
AR(ANMAT)
Asia-Pacific
TW(TFDA)
TW(TFDA)
AU(TGA)
AU(TGA)
North America
US(FDA)
US(FDA)
CA(NNHPD)
CA(NNHPD)
Southeast Asia
MY(NPRA)
MY(NPRA)
PH(PFDA)
PH(PFDA)
SG(HSA)
SG(HSA)
TH(TFDA)
TH(TFDA)
Europe
UK(SCPN)
UK(SCPN)
EU(CPNP)
EU(CPNP)
Asia-Pacific
NZ(EPA)
NZ(EPA)
TW(TFDA)
TW(TFDA)
CN(NMPA)
CN(NMPA)
AU(TGA)
AU(TGA)
JP(PMDA)
JP(PMDA)
North America
CN(CNF)
CN(CNF)
US(FDA)
US(FDA)
Southeast Asia
SG(HSA)
SG(HSA)
MY(MDA)
MY(MDA)
PH(PFDA)
PH(PFDA)
VM(MOH)
VM(MOH)
ID(BPOM)
ID(BPOM)
TH(TFDA)
TH(TFDA)
South America
BR(ANVISA)
BR(ANVISA)
Asia-Pacific
CN TW(TFDA)
CN TW(TFDA)
AU(FSANZ)
AU(FSANZ)
North America
CA(CFIA)
CA(CFIA)
US(FDA)
US(FDA)
Southeast Asia
MY(FSQD)
MY(FSQD)
PH(PFDA)
PH(PFDA)
SG(SFA)
SG(SFA)
TH pet food
TH pet food
TH(TFDA)
TH(TFDA)
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
Successful Cases
News Center
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English
English
Chinese
Chinese
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三个医生
Global Compliance
One-Stop Service
Medical Device
Health Food
Cosmetics
Foods
Value-added
Europe
  • EU(CE)
    EU(CE)
  • UK(UKCA)
    UK(UKCA)
  • CH(SWISSMEDIC)
    CH(SWISSMEDIC)
  • SRB(ALIMS)
    SRB(ALIMS)
  • IT(AIFA)
    IT(AIFA)
  • ES(AEMPS)
    ES(AEMPS)
    • Asia-Pacific
  • AU(TGA)
    AU(TGA)
  • JP(PMDA)
    JP(PMDA)
  • CN HK(MDACS)
    CN HK(MDACS)
  • KP(MFDS)
    KP(MFDS)
  • NZ(MEDSAFE)
    NZ(MEDSAFE)
  • CN TW(TFDA)
    CN TW(TFDA)
  • PK(DRAP)
    PK(DRAP)
  • UZ(MOH)
    UZ(MOH)
  • BD(DGDA)
    BD(DGDA)
  • CN(NMPA)
    CN(NMPA)
  • IN(CDSCO)
    IN(CDSCO)
  • KZ(FMXM)
    KZ(FMXM)
    • North America
  • US(FDA)
    US(FDA)
  • US(DMF)
    US(DMF)
  • CA(HC)
    CA(HC)
  • MX(COFEPRIS)
    MX(COFEPRIS)
    • Middle East
  • SA(SFDA)
    SA(SFDA)
  • UAE(MOHAP)
    UAE(MOHAP)
  • EG(EDA)
    EG(EDA)
  • TR(TITCK)
    TR(TITCK)
    • Africa
  • NG(NAFDAC)
    NG(NAFDAC)
  • KEN(PPB)
    KEN(PPB)
  • ET(EFDA)
    ET(EFDA)
    • Southeast Asia
  • TH(TFDA)
    TH(TFDA)
  • SG(HSA)
    SG(HSA)
  • VN(MOH)
    VN(MOH)
  • ID(MOH)
    ID(MOH)
  • MY(MDA)
    MY(MDA)
  • PH(PFDA)
    PH(PFDA)
    • South America
  • BR(ANVISA)
    BR(ANVISA)
  • PE(DIGEMID)
    PE(DIGEMID)
  • EC(ARCSA)
    EC(ARCSA)
  • CO(INVIMA)
    CO(INVIMA)
  • CL(ANDID)
    CL(ANDID)
  • AR(ANMAT)
    AR(ANMAT)
    • Asia-Pacific
  • TW(TFDA)
    TW(TFDA)
  • AU(TGA)
    AU(TGA)
    • North America
  • US(FDA)
    US(FDA)
  • CA(NNHPD)
    CA(NNHPD)
    • Southeast Asia
  • MY(NPRA)
    MY(NPRA)
  • PH(PFDA)
    PH(PFDA)
  • SG(HSA)
    SG(HSA)
  • TH(TFDA)
    TH(TFDA)
    • Europe
  • UK(SCPN)
    UK(SCPN)
  • EU(CPNP)
    EU(CPNP)
    • Asia-Pacific
  • NZ(EPA)
    NZ(EPA)
  • TW(TFDA)
    TW(TFDA)
  • CN(NMPA)
    CN(NMPA)
  • AU(TGA)
    AU(TGA)
  • JP(PMDA)
    JP(PMDA)
    • North America
  • CN(CNF)
    CN(CNF)
  • US(FDA)
    US(FDA)
    • Southeast Asia
  • SG(HSA)
    SG(HSA)
  • MY(MDA)
    MY(MDA)
  • PH(PFDA)
    PH(PFDA)
  • VM(MOH)
    VM(MOH)
  • ID(BPOM)
    ID(BPOM)
  • TH(TFDA)
    TH(TFDA)
    • South America
  • BR(ANVISA)
    BR(ANVISA)
    • Asia-Pacific
  • CN TW(TFDA)
    CN TW(TFDA)
  • AU(FSANZ)
    AU(FSANZ)
    • North America
  • CA(CFIA)
    CA(CFIA)
  • US(FDA)
    US(FDA)
    • Southeast Asia
  • MY(FSQD)
    MY(FSQD)
  • PH(PFDA)
    PH(PFDA)
  • SG(SFA)
    SG(SFA)
  • TH pet food
    TH pet food
  • TH(TFDA)
    TH(TFDA)
    • Clinical Trial
    Overseas Clinical Trial Services Australian Clinical Trial Services IVD Clinical Trial Services Clinical Trials
    More
    System Guidance
    Brazil BGMP MDSAP ISO 13485
    More
    Other Services
    Apostille Certification Free Sales Certificate Professional Translation Agent Services
    More
    Help Enterprises Reach Target Markets Faster
    50
    Regulatory Compliance and Clinical Trial Services across 50 Countries & Regions.
    15
    15 wholly-owned subsidiaries worldwide.
    600
    +
    Trusted Partner to 600+ Leading Enterprises.
    3000
    +
    Over 3,000 Successful Registrations & Certificates Issued.
    Global Self-operated Matrix
    More
    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)
    New Zealand
    New Zealand
    Spain
    Spain
    United Kingdom
    United Kingdom
    Brazil
    Brazil
    America
    America
    Thailand
    Thailand
    Japan
    Japan
    Vietnam
    Vietnam
    Singapore
    Singapore
    Indonesia
    Indonesia
    한국
    한국
    Malaysia
    Malaysia
    Hong Kong, China
    Hong Kong, China
    China
    China
    Compliance Certification Expertise
    More
    Masayuki KAWAHARA
    Masayuki KAWAHARA
    Consultant of Wiselink Japan Co., Ltd., Core Member of HBD in the PMDA-FDA Joint Project
    Dr. Nelson Xie
    Dr. Nelson Xie
    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.
    Dr. Joan Jiang
    Dr. Joan Jiang
    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.
    Ben Cowburn
    Ben Cowburn
    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
    More
    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.
    Policy Update｜Russia Delays Medical Device Traceability Pilot Program
    The Government of the Russian Federation has extended the national identification marking pilot project for medical devices to 28 February 2027. The pilot for glucose meters, originally scheduled to end on 31 August 2026, has been prolonged. Meanwhile, the pilot periods for blood glucose test strips and rapid test reagents are aligned with this same deadline. This pilot aims to combat counterfeit medical devices, ensure patient safety, and establish a full-chain traceability system.
    2026-09-09
    FDA Releases Public List of AI‑Enabled Medical Devices，Over 1,600 Products Listed！
    The U.S. FDA officially maintains and publishes the AI‑Enabled Medical Devices List, which catalogs 1,614 AI‑powered medical devices with marketing authorization. It serves as a reference for developers, hospitals and patients, advancing digital health innovation and regulatory transparency.
    2026-09-08
    Canada Updates Exceptional Import Medical Device Forms With New Declaration Requirements
    2026-09-07
    Vietnam Officially Adopts Apostille Certification on 11 September: Farewell to Consular Legalisation
    Vietnam will officially implement the Apostille certification system on 11 September 2026, replacing the traditional embassy‑based dual consular legalisation. This policy is legally underpinned by Vietnam’s Government Decree No. 293/2026/NĐ‑CP. Public documents issued in China may be submitted directly to Vietnamese drug regulatory authorities after completing notarisation, commercial attestation and Apostille certification, without further consular stamping by the Vietnamese Embassy in China.
    2026-09-04
    Regular Q&A
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    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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