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This is to report on the current situation regarding B-GMP (or “BPF”) certification by ANVISA. This regime came into effect on 22 May 2010. After this resolution was published in May 2009 there was widespread concern about ANVISA´s capacity to audit manufacturers all over the world. Now it is obvious that ANVISA does not have the resources to inspect manufacturers within the time frame established by law, which theoretically should more than 90 days after being required, but actually delays well over 6 months take place.

We require at least three years of experience in your field of expertise and a proven success record, which should be reflected in your CV/Resume/Bio. All information received from you will be kept completely confidential within the Arazy Group HR department and will not be shared with any third party without your written consent. You can remove yourself from the Arazy Group community of the international Medtech space professionals at any time and your personal information will be erased.

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. Like many other manufacturers, Elekta previously focused mainly on major markets, including Europe, North America, and countries like Brazil and China.

Even though the “sole paragraph” extends the scope to class I and class II products that go through product registration, it was understood that class I and II devices that go through the registration process would not be required B-GMP certificates for the time being due to the lack of capacity on ANVISA´s behalf to audit manufacturers in a timely fashion.

™ . This unique, cloud-based application provides you, the medical or IVD device manufacturer, with a comprehensive service that results in the successful registration of your product in South Korea and ownership of the registration license through your company.

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