Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Australia, New Zealand to Establish Joint Medical Device Regulator

The governments of Australia and New Zealand are setting up a single regulatory body to oversee therapeutic goods including medical devices and pharmaceuticals across both their countries.

The new entity, the Australia New Zealand Therapeutic Products Agency (ANZTPA), will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe—a move which both governments argue will further economic integration, benefit industry and more efficiently uphold public health.

The transition to ANZTPA will occur over a five-year, three-stage process. First, TGA and Medsafe will set up a work-sharing program and expand their joint operations. Second, the regulators will set up a single point of entry and regulatory framework for industry. Finally, ANZTPA will be formally launched.

The first stage of the transition will begin in July 2011; a transition agency including Australian and New Zealand health ministers will oversee all phases of the transition to ANZTPA.

In terms of funding, TGA and Medsafe will keep in place their current cost recovery schemes with industry during the early stages of the transition; eventually, regulatory costs will be folded into costs recovery arrangements with industry.

Markets: AustraliaTags: ANZTPA, Australia, Medsafe, New Zealand, Therapeutic Goods Administration

Author: Stewart EisenhartDate: June 23, 2011

GHTF Moves to Disband

The Global Harmonization Task Force (GHTF), founded in 1992 to promote uniformity across medical device regulatory regimes, will soon cease to exist according to the Medical Technology Association (MTA) of Australia.

Regulators from the US, EU, Japan, Australia and Canada, the GHTF’s founding members, elected to dissolve the group in order to form a new entity consisting solely of regulators; in its current iteration, the GHTF allows equal standing for medical device industry associations. The proposed new organization will purportedly seek feedback from medical device industry advocates, health care representatives and consumer groups as part of ongoing regulatory harmonization pursuits.

The GHTF will continue in its current form at least until its next meeting in May, according to the MTA.

Markets: Australia, Canada, Europe, Japan, USACategories: Regulatory ComplianceTags: Australia, canada, EU, GHTF, Global Harmonization Task Force, Japan, US

Author: Stewart EisenhartDate: March 4, 2011

TGA Improves Public Access to Medical Device Registry

The Therapeutic Goods Administration (TGA), Australia’s medical device and pharmaceutical regulator, has set up easier online access to its Australian Register of Therapeutic Goods (ARTG) database of approved products.

An electronic version of the ARTG is now available on the TGA’s website, and features improved functionality for selection and searching options. Users can now search new products recently added to the database, as well as by active ingredients.

Markets: AustraliaCategories: Regulatory ComplianceTags: ARTG, Australia, TGA

Author: Stewart EisenhartDate: March 1, 2011

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate strong support for adopting a risk-based classification for in vitro diagnostic devices (IVDs).

Among 116 manufacturers, notified bodies and other medical device industry stakeholders that provided comment, 93% of respondents saw the adoption of risk-based IVD classification based on the Global Harmonization Task Force (GHTF) model as a positive development, allowing for greater flexibility, stronger public health protections and timely market access for new products.

The cost of such a reclassification, however, was also highlighted by some respondents. Specifically, classification according to GHTF standards would necessitate greater regulatory involvement to handle conformity assessment procedures. In turn, manufacturing costs would increase, ultimately driving up prices for end users as well.

Nonetheless, respondents noted that additional costs would likely be offset by improved public health protections, and suggested a five-year transitional period for manufacturers to adjust to the new risk-based classification and its ensuing requirements. In addition, a risk-based IVD classification incorporating the GHTF model would boost European exports, some participants stated, but only if such classification were based on that model—otherwise, additional regulatory costs would not be offset by any financial benefits.

At this point, the EU Commission may discuss and consider these comments and then provide a draft which will likely include GHTF classification rules.

If EU regulators end up adopting these classification rules, Europe will become the second major market after Australia to implement GTHF risk-based classification rules for IVDs.

Markets: Australia, EuropeCategories: Regulatory ComplianceTags: 98/79/EC, Australia, EU, European Medical Device Directive, GHTF, Global Harmonization Task Force, IVD

Author: Stewart EisenhartDate: February 25, 2011

Certain IVDs Now Subject to Application Audits by Australia’s TGA

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.

According to Australia’s Therapeutic Goods (Regulations) 2002, eight types of IVDs fall under the application audit requirements:

Non assay-specific quality control materials for monitoring Class 4 IVDs
IVDs for self-testing applications
IVDs for point-of-care testing
Class 3 IVDs for detecting sexually transmitted agents
IVDs to monitor treatment of infections diagnosed with Class 4 devices
IVDs supplied for use according to the pharmaceutical benefit scheme
IVDs used in national screening programs
IVDs whose original manufacturing evidence does not fully satisfy Australian conformity assessments

IVD manufacturers and their sponsors whose products do not qualify for the mandatory audit requirements, however, should not consider themselves off the hook. The TGA also has the authority to select applications for such devices for non-mandatory audits, as well. In either case, the TGA will send written request to the sponsor for information necessary to conduct the application audit.

An application audit by the TGA will entail review of a manufacturer’s technical documentation; any data or documentation deemed by the regulator to be relevant to demonstrable compliance with safety and performance Essential Principles, conformity assessment procedures or advertising or supply information is fair game.

Sponsors should not submit application audit documentation until the TGA formally requests that information, advises the regulator’s website.

Markets: AustraliaCategories: Regulatory ComplianceTags: audit, IVD, TGA, Therapeutic Goods Administration

Author: Stewart EisenhartDate: February 16, 2011