2021年3月，TGA发布了临床证据指南：医疗器械的verision 2.0.

以下为译文，如有出入敬请谅解。

（一）指南描述：

医疗器械的临床证据指南旨在为医疗器械（包括体外诊断医疗器械（IVD））的制造商提供指导，包括什么构成临床证据以及产生此类临床证据的临床数据生成和临床评估过程。尽管本指南涉及IVD,但应承认此处提供的信息是不完整的。

本指南的各节提供了有关以下类型设备的临床证据要求的特定信息：

•    全部和部分关节假体

•    心血管装置，以促进通畅或功能流动

•    植入式脉冲发生器

•    心脏瓣膜假体

•    支撑装置-网格，贴片和组织粘合剂

在磁共振环境下，还有关于植入式医疗设备的特定章节（第10节）。

（二）指南具体内容包括：

•    介绍

•    立法依据

•    第1部分-一般要求

1.    基本原则

2.    临床证据

3.    临床评估报告和证明文件

4.    可比设备，包括基本等效的设备

•    第2部分-特定高风险设备的要求

1.    全部和部分关节假体

2.    促进通畅或功能流动的心血管装置

3.    植入式脉冲发生器系统

4.    使用人工瓣膜置换心脏瓣膜

5.    支撑装置-网格，贴片和组织粘合剂

6.    磁共振环境中的可植入设备

•     CER和证明文件

•     词汇表和缩写

•     原始资料

Clinicalevidence guidelines: Medical devices

Description

The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.

Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:

• Total and partial joint prostheses

• Cardiovascular devices to promote patency or functional flow

• Implantable pulse generators

• Heart valve prostheses

• Supportive devices - meshes, patches and tissue adhesives

There is also a specific section (Section 10) on implantable medical devices in the magnetic resonance environment.

Contents

• Introduction

• Legislative basis

• Part 1 - General requirements

1. The essential principles

2. Clinical evidence

3. Clinical evaluation report and supporting documents

4. Comparable devices including substantially equivalent devices

• Part 2 - Requirements for specific high risk devices

1. Total and partial joint prostheses

2. Cardiovascular devices to promote patency or functional flow

3. Implantable pulse generator systems

4. Heart valve replacement using a prosthetic valve

5. Supportive devices - meshes, patches and tissue adhesives

6. Implantable devices in the magnetic resonance environment

• CER and supporting documents

• Glossary and abbreviations

• Source material