Company Profile - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Your Strategic Partner in
Global Regulatory Excellence

Wiselink Medical Consulting (Shenzhen) Limited (Wiselink CN) is a key subsidiary of Wiselink Group

(Sydney, Australia).With a robust global footprint,Wiselink Group operates 15 subsidiaries across

strategic markets,including USA,UK,Spain,Switzerland,New Zealand,Brazil,Japan,South Korea,Singapore,

Malaysia,Vietnam,Thailand,Indonesia,China and Hong Kong China.

Upholding the philosophy of "founded in Australia, rooted in China, serving the world" and adhering to the core values of professionalism, sincerity and openness, Wiselink is committed to providing efficient,professional one-stop global regulatory compliance certification and clinical trial services for manufacturers of medical devices,health supplements,cosmetics,food and Traditional Chinese Medicine (TCM),empowering products to successfully enter target markets worldwide.

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

16 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

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

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

Quality Management System Services

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

Post-marketing Services

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

Local company establishment services

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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