Software Regulated as Medical Devices – Looking at Other Markets, Globally - Part 2

13 June 2011

In April, this blog explored how software may be regulated as a medical device in the European Union (EU), along with looking at the U.S. and Canadian markets. The definition of a medical device in the latest version of the Medical Device Directive now specifically lists software as a medical device if it is intended by the manufacturer to be used for one or more of the medical purposes set out in the definition. While the EU, Canada and U.S. are currently working within a regulatory framework that established requirements for software to be regulated as a medical device, the question still remains: What about other markets?

One market receiving recent attention is Taiwan. For those medical device manufacturers wishing to sell in Taiwan, they have to follow a specific process before any of their products can be placed on the market. The documents required for these manufacturers include:

  • Quality system documents and procedures (in English and/or local Taiwanese language);
  • Floor plans of the manufacturing site;
  • Process flow diagrams for each product; and
  • Technical file for each product (in English and/or local Taiwanese language).

Following this process and including this documentation is what is referred to as Taiwan's Technical Cooperation Program (TCP). This program allows European medical device manufacturers to significantly reduce the documentation needed to gain market approval in Taiwan.

"While this program has many benefits, the QMS must be reviewed and audited by the Taiwanese in order to meet the requirements of the market's regulations," said Ron Nash Technical Manager, Intertek, Europe. "This process is simplified through Technical Cooperation Program with the E.U. where designated Taiwanese certification bodies – working with the Taiwanese Health Authority only – require an audit report from a designated number of Notified Bodies, along with a copy of the 13485 certificate. The downside to this operation is that the manufacturing location must be located in the EU."

As new market updates become available for software regulated as a medical device, this blog will post the country specifics on a rolling basis.

To learn more and or to speak with an Intertek expert on this subject matter, e-mail us at askmedical@intertek.com.