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

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