Perspective

1 December 2011

Will Global Medical Device Trade Improve With Accredited ISO 13485 Certification?

By Grant Ramaley

One of the things that never really changes in the field of medical device compliance is how we look at solving our trade problems. For decades, we heard, “Accepted once, accepted everywhere. Harmonization is the answer.”

But the collapse of the Global Harmonization Task Force (GHTF) and much food fight-style banter at the World Trade Organization (WTO) mean too little progress has been achieved in serving up solutions that genuinely improve medical device trade.

The main problem with harmonization within the public health protection sphere stems from the sincere obligations of regulators to protect their own people. As a result, what happened at GHTF can be seen as a movement away from harmonization, as each nation creates a custom version of the harmonized guidance.

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