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TestingTesting
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How to get your medical device tested in China

How to get your medical device tested in China

Elaine Tan
TestingTesting
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Your Blueprint to the Product Technical Requirements (PTR)

Your Blueprint to the Product Technical Requirements (PTR)

Elaine Tan
TestingTesting
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Mandatory or Recommended? Demystifying China’s Medical Device Standards

Mandatory or Recommended? Demystifying China’s Medical Device Standards

Elaine Tan
RegistrationRegistration
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Secure Made‐in‐China Approval by Moving Production to China

Secure Made‐in‐China Approval by Moving Production to China

Elaine Tan
Clinical TrialClinical Trial
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Clinical Evaluation Routes for Medical Devices in China

Clinical Evaluation Routes for Medical Devices in China

Elaine Tan
Clinical TrialClinical Trial
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Can a medical device be exempt from Clinical Evaluation?

Can a medical device be exempt from Clinical Evaluation?

Elaine Tan
Clinical TrialClinical Trial
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Entering the China Market: Clinical Trial vs Clinical Trial Exemption

Entering the China Market: Clinical Trial vs Clinical Trial Exemption

Elaine Tan
RegistrationRegistration
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Navigating the NMPA Registration Process: Timelines, Costs, and Considerations

Navigating the NMPA Registration Process: Timelines, Costs, and Considerations

Elaine Tan
China AgentChina Agent
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Potential Changes to the In-Country Agent Role in China in 2025

Potential Changes to the In-Country Agent Role in China in 2025

Elaine Tan
China AgentChina Agent
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Qualifications of an Authorized Representative in China

Qualifications of an Authorized Representative in China

Elaine Tan
Medical DeviceMedical Device
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Unable to identify the risk class or product category?

Unable to identify the risk class or product category?

Elaine Tan
Medical DeviceMedical Device
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Classification of Medical Devices in China

Classification of Medical Devices in China

Elaine Tan
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