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By: Ludger Möller
News and Views: High Priority
April 2008
Content:
New Italian Device Registration Requirements
Dear valued client,
With this newsletter we would like to inform you of the new
registration requirements which recently have been implemented
for medical devices in Italy. With the approval of the Italian
Decree of February 20, 2007 new registration procedures were
introduced for class I, IIa, IIb and III products and as well as
for systems, kits and active implantable devices. To comply with
the new requirements, each medical device placed on the Italian
market needs to be registered in the databank of the Italian
Ministry of Health by the manufacturer, his European
Representative or his distributor. The registration is
compulsory and only those devices that are registered will be
released for sale to Italian hospitals and public health
organizations.
Registration requirements were already in place in Italy for a
number of years and it seemed that distributors performed the
registration without the knowledge of the manufacturer or they
were simply not enforced as such. The registrations that already
were performed in Italy before the implementation of the new law
will stay valid; however, as of January 1, 2009 public health
organizations will not be allowed to purchase the products if
they are not registered according to the new regulations.
The below aspects need to be considered in regards to the new
requirements.
Registration Timelines:
August 1, 2007: All devices which were first placed on the
Italian market after May 1, 2007 need to be registered by August
1, 2007. Otherwise they will not be admitted for sale to public
health organizations.
January 1, 2009: All devices that were already placed on the
Italian market before May 1, 2007 (and consequently were already
inserted into the former Italian device databank) need to be
registered by that time. Otherwise the sale to public health
organizations will not be possible.
Registration Procedure:
For the purpose of the new regulation the Italian Ministry of
Health recently installed a medical device databank that allows
the manufacturers or their representative to register the
products online. The products need to be registered individually
or per product family (i.e. all products that share the same
technical file). Apart from a national nomenclature system (CND)
the Italian Ministry of Health uses the GMDN code system to
identify the corresponding product groups. According to the
authority, the registration process needs approximately 3 months
to be completed, depending on the lead time at the Ministry of
Health. Once the process is finalized, the Ministry of Health
will assign a notification number to each registered
product/product family.
Registration Fees:
The applicable registration fees are laid down in the Italian
Decree of March 20, 2007. The fees that are charged by the
Ministry of Health for the registration of one product/product
family amount to € 100, which need to be paid in advance.
The official medical device website of the Italian Ministry of
Health is the following:
http://www.ministerosalute.it/dispositivi/dispomed.jsp
Most of the information provided by the Italian Ministry of
Health is in Italian only. The following link provides some
English information on the first steps of the registration
process:
http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=395&menu=registrazione
Appoint MDSS to perform the Italian registration on your
behalf
As your European Authorized Representative we will be able to
perform the Italian product registration on your behalf. To deal
with the language barrier we recently hired additional staff
that is fluent in Italian and we are currently in the process of
evaluating and summarizing the information that will be required
for registration.
If you would like MDSS to perform the registration in Italy on
your behalf, please feel free to contact us and we will be more
than happy to provide you with more detailed information.
Due to the tight registration timeline, we recommend to evaluate
as soon as possible whether you would like to have your products
registered with the Italian Ministry of Health in order to
finalize the process by January 1, 2009.
We hope that the above information is helpful. Certainly we are
at your disposal for any further questions you may have
regarding this matter
Best regards,
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