Your Strategic Partner in
Global Regulatory Excellence

Wiselink Supply Chain Services (Shenzhen) Co., Ltd. (Wiselink CN) is a key subsidiary of Wiselink Group (Sydney, Australia). With a robust global footprint, Wiselink Group operates 16 subsidiaries across strategic markets, including  Spain, Brazil, USA, Japan, the United Kingdom, Indonesia, Singapore, Thailand, New Zealand, Vietnam, South Korea, Malaysia, and China.

Wiselink CN boasts an elite international team, including our independent Chief Consultant, Dr. Derrick Beech, former Director of the Australian Therapeutic Goods Administration (TGA) Medical Device division. Guided by our core values of Professionalism, Sincerity, and Openness, we bridge the gap between Australian heritage and Chinese market expertise to serve a global clientele. We are committed to providing comprehensive global regulatory affairs (RA) consulting and clinical trial services for manufacturers of medical devices, cosmetics, food, health supplements, and Traditional Chinese Medicine (TCM).

View Our Locations
40
Regulatory Compliance and Clinical Trial Services across 40 Countries and Regions.
15
15 Directly managed Subsidiaries Established Worldwide.
600
+
Trusted Partner to 600+ Leading Enterprises.
3000
+
Over 3,000 Successful Registrations and Certificates Issued.
Professionalism
Built on a foundation of systematic knowledge and "penetrative" problem-solving. We provide irreplaceable value through a dynamic expertise system that evolves to master the complexities of global regulatory environments.
Sincerity
Rooted in integrity and character. We foster a secure team culture where transparency is the standard and the long-term cost of concealment far outweighs any temporary gain.
Openness
We don't just deliver stamped certificates; we demystify the "black box" of regulation. We provide total transparency, allowing clients, auditors, and stakeholders to clearly see the inner mechanics of the regulatory process.
Service Portfolio
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
Registration Services
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
  • Pre-registration consultation and liaison with regulatory authorities
  • Assistance in customs clearance for local testing samples
  • Prepare regulatory-compliant application documents
  • Application for Free Sale Certificates (FSC)
  • Communication of feedback from regulatory authorities
  • Payment of official fees on behalf of clients
  • Provision of registration document checklists
  • Document review and gap analysis
  • Classification determination applications
  • Local authorized representative services
  • Apostille certification (Hague Convention)
  • Assist with regulatory RFI responses
  • Submission of official registrations
  • Assistance with local testing
  • Review of label compliance
  • Embassy notarization
  • Document translation services
Technical Documentation Consulting Services
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
  • Statistical analysis of clinical trial data
  • Preparation of clinical evaluation reports
  • Preparation of complete technical documentation
  • Development of clinical trial protocols
  • Clinical Trial Project Management
  • Provision of testing requirements
undefined
Quality Management System Services
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
  • Assist in obtaining local authorized representative certificates
  • Provision of quality system document checklists
  • Development of quality system documents
  • System training and internal audits
  • Development of risk control plans
undefined
Post-marketing Services
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
  • Post-marketing surveillance personnel services
  • Inclusion in medical insurance database
  • Registration Certificate modification/updates
  • Change of local authorized representative
  • Importer-of-Record
  • Local sample storage
undefined
Local company establishment services
Wiselink leverages the expertise of global medical device and IVD regulatory consultants to help clients enter key markets, design global strategies, and address critical regulatory challenges with the support of our experienced team.
  • Assistance in obtaining importer qualification certificates
  • Assistance in obtaining distributor qualification certificates
  • Client social security contribution payment service
  • Assist in obtaining local AR qualification certificates
  • Creation and submission of registration system accounts
  • Assistance in company establishment
undefined
Contact Us
Fill Form
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.