The first half of the year is about to end and it is better to start thinking about registrations, notifications, or expiring licenses.

In fact, medical device manufacturers not only find difficulties in international product or establishment registrations hard work, but also in scheduling activities to renew them within the deadlines. For companies that adopt a consolidated internationalization policy, proper and timely planning and renewals management is undoubtedly a crucial activity.

First of all, in the next months, the FDA, in particular the Center for Devices and Radiological Health (CDRH), will require the renewal of marketing notifications to radiation-emitting devices manufacturer companies. By September 1, each year, ionizing or non-ionizing radiation-emitting devices manufacturers must submit the Annual Report to CDRH in accordance with the 21 CFR 1002.13 requirements.

Through the Annual Report, the manufacturer notifies the FDA of the data he shall collect and maintain in the post-market phase: non-conformities or defects and resolution related management, any changes made to the device that do not involve forwarding a Supplemental Report, the number of units sold. The data included in the Annual Report relate to the period from July 1 to June 30 of the previous year and allow to obtain a new and different Accession Number to keep on marketing.

Starting from October 1 of each year, the FDA requires the Establishment Registration renewal which must be completed between October 1 and December 31. This renewal, unlike the above mentioned notification to the CDRH, also involves the payment of a $3,382 fee for 2017.

The renewal time frame proposed for establisment registrations in the US also covers the Medical Device Application Licenses (MDAL) renewal deadline in Canada. Class II, III or IV medical device manufacturers who obtained a license to market their products in Canada must renew their license annually by November 1 of each year with Health Canada to continue selling in the territory.

Health Canada also requires the Medical Device Establishment Licenses (MDEL) annual renewal to Class I medical device manufacturers and medical device distributors in Canada. This renewal must be made by April 1 of each year, so it is time to think about 2018 (read “CANADA: three changes not to be missed“).

2017 is an important year with a specific date to remember, especially for medical device manufacturers who obtained a registration and intend to continue marketing their products in Ukraine. On July 1, 2015, in fact, new technical regulations governing Medical Devices marketing in the country entered into force in Ukraine, setting a transitional period during which the registration certificates obtained in accordance with the above regulations would also be accepted. Now, the transition period will end on July 1, 2017, the date from which the validity of all registration certificates obtained before July 1, 2015 will expire. Medical Device manufacturers intending to maintain their interest for the Ukrainian market will have to renew their registration certificates.

Not to forget, then, that even selling to other countries implies monitoring the deadlines shown in the certificates!

Would you like to be always updated about Thema’s activities? Sign up to our newsletter!

THEMA - Logo TRASPARENTE_small

Silvia Scarpellini
RA Manager