Medical Device Import Second Opinion Review

Medical Device Import Second Opinion Review

1. What this review is

The Medical Device Import Second Opinion Review is a written, independent assessment of an existing or proposed plan to import a medical device into China.

It is designed for situations where you already have:

  • A defined medical device product
  • A proposed China entry or registration approach
  • An internal or third-party regulatory opinion
  • Remaining uncertainty around feasibility, risk, or classification

This review focuses on structural feasibility and compliance risk, based strictly on publicly available regulatory rules and regulatory logic.

2. What this review is NOT

This review is not:

  • A registration, filing, or approval service
  • A clinical evaluation or testing service
  • Legal advice or a substitute for regulatory approval
  • An execution or implementation guide
  • A guarantee of market access or registration success

No submissions, authority communication, or negotiation are included.

3. How this review works

This review is conducted asynchronously and entirely in writing.

Process:

  1. You submit written background information and materials
  2. The review is conducted based on publicly available medical device regulations
  3. A written Second Opinion summary is delivered

No live calls or real-time discussions are required.

4. What you need to prepare

To request a Second Opinion Review, please be prepared to provide:

  1. A description of the medical device product
  2. Intended use and clinical positioning
  3. Product classification assumptions (if any)
  4. Manufacturing country and basic facility information
  5. Proposed China entry or registration approach
  6. Key concerns or uncertainties you would like reviewed

All materials should be submitted in writing.

5. When this review is typically used

This review is commonly requested when:

  • Medical device classification is unclear or borderline
  • Regulatory burden may exceed commercial viability
  • Internal and external opinions conflict
  • Market entry decisions involve significant cost or timing risk
  • An objective, written assessment is preferred over discussion

6. Request a Second Opinion

If you believe a Medical Device Import Second Opinion Review may be appropriate, please proceed via the link below.

6.1 Before you submit (2–3 minutes)

This review focuses on medical device regulatory positioning and import feasibility under China’s device supervision framework.

Please describe the product based on its intended medical use.

6.2 Field guidance

  • Company / Brand Name

    • Legal entity or brand planning device import.

  • Country / Region

    • Manufacturing country and exporting country.

  • Product Description

    • Intended use, user type, and basic operating principle.

  • Product Category (client wording)

    • Your internal classification or device description.

  • Proposed Entry Path

    • General Trade or other considered structure.

  • Current Plan or Advice Received

    • Any prior guidance regarding classification, registration, or filing.

  • Primary Concern / Question

    • The key uncertainty you want reviewed.

  • Timeline Sensitivity

    • Planned registration or import schedule.

  • Supporting Documents (optional)

    • Product brochure, IFU draft, label draft, or prior regulatory feedback.

6.3 What happens after submission

You will receive a written Second Opinion focused on regulatory positioning, risk exposure, and decision logic under public rules.

👉 Submit a Medical Device Import Second Opinion Request