Your Strategic Partner in
Global Regulatory Excellence

Wiseline Supply Chain Services (Shenzhen) Co.,Ltd. (Wiseline CN) is a key subsidiary of Wiseline Group headquartered in Sydney, Australia. Boasting an extensive global layout, Wiseline Group has established 14 subsidiaries covering key strategic markets, namely Spain, Brazil, the United States, Japan, the United Kingdom, Indonesia, Singapore, Thailand, New Zealand, Vietnam, South Korea, Malaysia, Hong Kong SAR and mainland China.

Wiseline is equipped with an international expert team headed by Dr. Derrick Beech, ex-Director of Australia’s Therapeutic Goods Administration (TGA), who acts as our chief consultant. Adhering to the development tenet of “founded in Australia, rooted in China, serving the whole world”, as well as the core values of professionalism, sincerity and openness, we dedicate ourselves to delivering efficient and professional one-stop global regulatory compliance certification and clinical trial services. Our service targets manufacturers engaged in medical devices, cosmetics, food, health supplements and Traditional Chinese Medicine (TCM), helping customers’ products smoothly access various target markets worldwide.

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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
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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
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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
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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
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