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Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.
I recently had to deal with a company that had changed contract manufacturers; the legal manufacturer and owner of design control remained the same. This move also involved a change in the country of origin. We were concerned specifically how this affected the current license in Canada. I read the Health Canada Guidance for Interpretation of Significant Change of Medical Device and the License Amendment Fax-Back Form from the Health Canada website. After reading these documents, I felt that an amendment to the license was necessary. I wasn't entirely sure. I asked a few colleagues for their opinion. After reading carefully, none of us were fully clear what path we needed to take in order to meet the requirements.
However, the one great thing about Health Canada is that the Medical Device Bureau is as polite and helpful as the rest of the country. We were quickly able to get clarification via email from the Device Licensing Services Division. Basically here is what we found out: If the products in question are Class II devices, then a License Amendment Fax-Back Application is not required (you can inform Health Canada when the product is renewed). However, if the devices in question are Class III or IV, then a License Amendment Fax-Back Application is needed.
Luckily, our devices were Class II, so we did not need to fill out the License Amendment Fax-Back Form. Thanks for your help, Canada!
Health Canada Guidance for Interpretation of Significant Change of Medical Device please see the following website:
License Amendment Fax-Back Form please see the following website:
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_licnamechng_fm_modnomhom-eng.php
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