Hong Kong · Medical Devices

Labelling and IFU in Hong Kong

A practical guide to Labelling and IFU for medical devices sold in Hong Kong: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Device labels and instructions must be in the local language and carry the required symbols; Brands distributing devices through local partners

Authority

Hong Kong Customs and Excise Department

Legal basis

National medical devices requirements in Hong Kong

Local representative

A local licence holder or authorised representative is required

Timeline

Registration can take months; plan early

Cost

Clinical evidence and QMS audits dominate cost

If you do not comply

Import ban, seizure, and enforcement action

Who needs this

Device labels and instructions must be in the local language and carry the required symbols
Brands distributing devices through local partners

Documents you need

Local-language label and IFU
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Local-language label and IFU
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

How to comply

Translate and verify label and IFU content
Classify the device under local rules
Prepare technical documentation
Complete registration or notification

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Labelling and IFU — Hong Kong
Product category: Medical Devices
Authority: Hong Kong Customs and Excise Department
Legal basis: National medical devices requirements in Hong Kong

Documents we already have:
  1. Local-language label and IFU
  2. Regulatory classification and registration
  3. Clinical or performance evidence
  4. Quality management system certificate

Questions:
  1. Does our product fall under Labelling and IFU in Hong Kong?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Registration can take months; plan early.

Clinical evidence and QMS audits dominate cost.

Common rejection reasons

IFU not in the local language
Wrong risk classification
Clinical evidence insufficient
QMS certificate not accepted

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs Labelling and IFU in Hong Kong?

Device labels and instructions must be in the local language and carry the required symbols Brands distributing devices through local partners.

What documents are required for Labelling and IFU?

Local-language label and IFU; Regulatory classification and registration; Clinical or performance evidence; and quality management system certificate.

What is the first step for Labelling and IFU?

Translate and verify label and IFU content. Registration can take months; plan early.

How long does Labelling and IFU take?

Registration can take months; plan early.

How much does Labelling and IFU cost?

Clinical evidence and QMS audits dominate cost.

What happens if I sell without it?

Import ban, seizure, and enforcement action.

Who regulates Labelling and IFU in Hong Kong?

Hong Kong Customs and Excise Department.