International Medical Device Regulations...

Information & Training. | Medical Devices.

US FDA – European Directives – Australia TGA – International.

There are a range of regulatory bodies controlling and monitoring the release to market of medical devices throughout the international market place.

One of the key bodies which influenced the international medical devices regulatory environment, was the Global Harmonization Task Force (GHTF). The GHTF was established 1992. It has now been replaced in The International Medical Device Regulators Forum (IMDRF). The GHTF worked at reducing differences between the varying aspects of regulatory affair systems and encouraged regulatory affairs convergence.

Today the IMDRF comprises regulatory authority representatives from:

• Australia, Therapeutic Goods Administration
• Brazil, National Health Surveillance Agency (ANVISA)
• Canada, Health Canada
• China, China Food and Drug Administration
• Europe, European Commission Directorate General Health and Consumers
• Japan, Pharmaceuticals & Medical Devices Agency & the Ministry for Health.
• Russia, Russian Ministry of Health
• United States of America, US Food and Drug Administration

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

Key International Medical Device Regulations Legislation:

In Europe there are various medical device directives such as the EU MDD 93/42/EEC (Medical Device Directive). In the United States, there are the U.S. FDA CFR Regulations. In Australia medical devices are regulated by the Therapeutic Goods Acts. In addition there are a range of individual and inter-county MOU’s (Memorandum’s of Understanding) and PECA’s (Protocols to the Europe Agreements on Conformity). Plus a range of guidance documents such as those issued by the GHTF (now the IDMRF).

The leading International Medical Device Regulations Agencies:

USA, F.D.A. – US Food and Drug Administration

Europe, N.B. & C.A. – Notified Bodies and Competent Bodies

Australia, T.G.A. – Therapeutic Goods Administration. Now the Australia New Zealand Therapeutic Products Agency (ANZTPA).

Canada, H.C. – Health Canada

China, SDA – Chinese State Food and Drug Administration

Singapore, HSA – Health Sciences Authority

Japan, MHLW – Ministry of Health, Law and Welfare

U.S. – F.D.A

The FDA mission is to help promote and protect public health. The FDA C.F.R. – (Code of Federal Regulations) – Title 21 Food and Drugs is composed of 9 volumes.[21 CFR § 820]

FDA carries out its mission through the FD&C Act: “to ensure that products produced are safe and effective for their intended use. Labeling is truthful, informative and non deceptive”.

The US FDA utilizes a top down approach based on the Quality System Inspection Technique (QSIT). The QSIT acknowledges that non-conformances and quality problems occur, but are they being identified? Did CAPA (corrective action and preventative action) occur by the employer and was it effectively implemented?
Key components of the quality system are audited, such as : medial device reporting, corrections and removals, production and process controls, CAPA, design control, management controls, medical device tracking, sterilization process controls, sampling plans, etc., etc..

Under the FDA QSR (Quality System Requirements), there are 4 major subsystems that are the basic foundation of a firm’s Quality System:
Management Control
Corrective & Preventative Action
Design Control
Production & Process Controls.

International Medical Device Regulations – The European Medical Device Regulations

Due to Harmonization, there are New Approach Directives within the EU, namely the

• Medical Device Directive (MDD) 93/42/EEC

• Active Implantable Directive 90/385/EEC

• In Vitro Diagnostics Directive 98/79/EEC

The above Directives are now being replaced by the Medical Device Regulations >>>

Manufacturers must ensure that every device placed on the market complies with the relevant Directive. They must apply the CE Mark and must ensure continued compliance with the relevant Directive.

European Medical Devices Directive 93/42/EEC >>>

Authorised representative:

The person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed onto the European market. Non-EU based manufacturers to appoint a designated person who has a registered place of business within the EU prior to the placement of Medical Device onto the EU market.

Competent Authority:

The body who acts on behalf of a member state to designate Notified Bodies to carry out conformity assessment procedures and ensure the requirements of the relevant Medical Device Directive have been implemented.

Notified Body:

The Certification organization which the Competent Authority has designated to carry out Conformity Assessment procedures. Example Notified Bodies are KEMA, TUV, BSI, … Each Notified Body has a unique identification number, e.g.0050 and 344 to that the certification body can easily be traced from any Medical Device on the market.

Australian Medical Device Regulation

The Therapeutic Goods Administration (TGA) is responsible for the regulation of medical devices manufactured in Australia or supplied onto the market within Australia. All medical device must be detailed in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. The TGA takes a risk based approach to regulation. The amount of regulatory control needed to manage risks depends on the product and determines how consumers gain access to the product. A low-risk product may be safely sold in a supermarket; high risk products may only be supplied by prescription after consultation with a health professional.
The risks involved with therapeutic goods can be divided into two types:

– Product risks: These risks are inherent to the product. They also include the risks involved in overdose (i.e. patient non-compliance).

– Compliance risks: These risks are related to the risks involved if a manufacturer or sponsor fails to comply with legal requirements (either unintentionally or intentionally).

The TGA actively regulates both product risks and compliance risks. The TGA regulates therapeutic goods before the products reach the market (pre-market) and afterwards, when they are in general use (post-market).

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>