【Case Study】Medical Device Combined Package Registration in China

1. Introduction

Product Name: The intended use, such as disposable sterile surgical bag, vertebral body forming kit, first aid kit, etc.

Product Composition:

Components

Working Principle:

The working principle/action mechanism of the components and the interaction between the components.

Structure: Component as the structure of the package

2. Classification

According to the ‘Medical Device Classification Rules’, if two or more classifications are applied to the one medical device, the actual classification should base on the highest degree of risk; the classification of the medical device combined package should base on the medical device with the highest degree of risk. The medical devices with the highest management category in the package are classified as categories.

3. Registration Unit

Two or more instruments that are completely unrelated, and devices that cannot perform a certain function should not be registered in the same instrument package.

4. Technical Requirements

Component performance, package appearance, sterility (if applicable), EO residue (if applicable), outsourced component marketing authorization

Table 1 Relevant Product Standards

Standard Number

Standard Name

YY 0321.1-2009

Single use anesthesia puncture package

YY/T 0720-2009

Single-use product package for natural childbirth

Guidelines for the technical review of the registration of single-use sterile surgical kits

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation) 

5. Clinical Trials

If all components are exempted from clinical trials, the clinical trial is not required.

If clinical trials are required for one or more components, the clinical trial is required.

6. Registration Cost and Duration

1) Product Testing

Test items

Testing duration

Testing fee(USD)

Safety Performance

60 working days

Based on components

Biocompability

60 working days

Based on components

 

2) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

3) Administrative Approval

20 working days

 

If you would like to get the detailed registration proposal, please contact us via md@cirs-group.com.

Contact Us
CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com