Australian TGA Medical Device Regulations
- Medical Devices
Guidelines for advertising medical devices in Australia.
Using medical devices in non-conventional therapies.
Animal Material, Devices Using
Minimizing risks associated with Transmissable Spongiform Encephalopathies (TSE).
Application Audits, Medical Devices
Requirements before an application can be filed, product audits, contents, etc.
Talks about distinctions between medical devices and medicines. Provides examples.
Role of clinical evidence, data generation, requirements of a clinical evaluation.
Assessment Certificate Conditions
Discusses entry and inspection powers, review requirements, fees and more.
What is a CAP, examinations for all device classes, plus post-market monitoring
Declaration of Comformity Overview
Covers purpose of the DOC, responsibility for conformity assessment and procedures.
of Medical Devices
Discusses different classes of devices and rules for invasive and non-invasive devices.
Principles for Medical Devices
Discusses medical device safety, intended purpose, minimization of risk and much
Essential Principles Checklist
Detailed checklist the directly correlates with the Essential Principles listed
General requirements for device labels, including sterile and non-sterile products.
Manufacturers, Standards For
How overseas manufacturers must demonstrate their goods meet acceptable standards.
Discusses postmarket surveillance, compliance, adverse events, vigilance and more.
Overview of the new medical devices regulatory system.
Role of the Sponsor/Manufacturer related to documentation, design, certification,
Requirements for wrappers, seals, packs, tubes, etc.. Covers validation and labeling.
Complete schedule of fees as of 1 July 2004.
Canadian Medical Device Regulations (CMDR)
Full text of the Canadian MDR as part of the Food and Drugs Act of 1998.
Transition to ISO
Brief document that discusses timeline for transitioning to ISO 13485:2003
ISO 13485 Audit
Guidance document that discusses ISO 13485 QS audits performed by CMDCAS registrars.
Listing of registrars reconized by Health Canada and standards to which they may
Health Canada Licensing
Document detailing all medical device licensing and other fees for Canada.
European Medical Device Regulations
Implantable Medical Devices Directive (AIMDD)
Full text of European directive 90/385/EEC that governs active implantable medical
Diagnostic Devices Directive (IVDD)
Full text of the European IVD directive 98/79/EC that governs in-vitro diagnostics.
Directive, Full Text (MDD)
Full text of the European Medical Devices Directive 93/42/EEC.
Medical Device Directive, Proposed Changes (MDD)
December 2005 version of 93/42/EEC showing proposed changes.
Protective Equipment Directive (PPE)
Full text of the European directive 89/686/EEC that governs personal protective
MEDDEV 2.1/1 - Defines
Medical Devices, Accessories and Manufacturer.
MEDDEV 2.2/1 REV 1
- Addresses EMC requirements.
MEDDEV 2.1/2.1 - Computers
used to program implantable pulse generators
MEDDEV 2.1/2 REV 2
- Application of the Active Implantable Device Directive
MEDDEV 2.1/3 REV 2
- Demonstrates demarcation between the AIMDD and MDD.
MEDDEV 2.2/3 REV 3
- Discusses the "Use By" date.
MEDDEV 2.1/4 - Discusses
demarcation between the EMC and PPE Directives.
MEDDEV 2.1/5 - Addresses
medical devices with a measuring function.
MEDDEV 2.4/1 REV
8 PART 1 - Classification of medical devices. Part 1 of 2.
MEDDEV 2.4/1 REV
8 PART 2 - Classification of medical devices. Part 2 of 2.
MEDDEV 2.5/9 REV 1
- Medical devices containing natural rubber latex.
MEDDEV 2.5/3 REV 2
- When a quality-related inspection of a subcontractor is needed.
MEDDEV 2.5/5 REV 3
- Clarifies translation procedures.
MEDDEV 2.5/6 REV 1
- Defines homogeneity of production batches.
MEDDEV 2.5-7 REV 1 -
Discusses conformity assessment for breast implants.
MEDDEV 2.5-8 REV 2
- Deals with assessment of devices with animal materials.
MEDDEV 2.7.1 - Talks
about evaluation of medical device clinical data.
MEDDEV 2.10-2 REV 1
- Designation and monitoring of Notified Bodies
MEDDEV 2.11/1 REV 1 - Risk management
in animal tissue products - TSE.
MEDDEV 2.12-1 REV 4
- Notification and evalution of adverse incidents.
MEDDEV 2.12-2 - Post
market clinical follow up for medical devices.
MEDDEV 2.14/1 REV 1
- Borderline issues between the IVD and Medical Device Directives.
MEDDEV 2.14/2 REV 1
- Dealing with IVD products for research use only.
MEDDEV 2.15/2 REV 2
- Different committees or organizations related to medical devices.
Japanese Medical Device Regulations & Guidelines
Review - January 2005
US FDA Medical Device Regulations & Guidelines
Guidance for Medical Device Manufacturers
Text related to FDA 21 CFR 820.30 and subclause 4.4 of ISO 9001.
and Cosmetic Act
Section of Act as it relates to medical devices including Chapter 5, Subchapters
A & E.
Labeling for Medical
Guidance on medical device labeling from the FDA
US FDA QSR regulation and Good Manufacturing Practices (GMP).
Guidance on criteria and approaches for medical device post-market surveillance.
in Medical Device Design
Discusses the CDRH push to have manufacturers apply Human Factors to device design.
Export Markets for Medical Devices
A 2003 study of medical device export potential. Source: U.S. Dept. of Commerce
Technology Industry At A Glance
Details size of US and world medical device market. Source: AdvaMed, 2004
Glossary of Terms
Basic directory of medical device quality and regulatory terms, acronyms and definitions.