Modified ordering requirements for export certificates (FSC)

Advance notice – Swissmedic to modify requirements for export certificates (FSC) with effect from 13 February 2019

30.01.2019 

In summer 2018, Swissmedic announced that it would be adopting a new practice with regard to the issuing of export certificates. Following a transition period that ended on 19 October 2018, the previous process has now been superseded. 

Now that a certain amount of experience has been gained with the new process, the initial findings have been reviewed. Even though stakeholders were amply informed of the new process well in advance, problems have been unexpectedly common. The ordering requirements clearly constitute the biggest challenge since they are frequently not fully observed. This results in Swissmedic having to reject or file objections to a large number of orders. 

Particular problems occurred with grouping medical devices (section 4.5 of the information sheet, section 3 of the order form). This requirement is necessary to ensure that the workload involved in assessing the conformity of medical devices on the basis of the documentation submitted for them remains within reasonable limits. Swissmedic was aware that the number of orders it receives would increase. However, because ordering under the new procedure is entirely electronic, the requirement also makes processing more efficient. When the Fees Ordinance was revised, the fees for issuing an export certificate were reduced accordingly from CHF 300 to CHF 200. 

In some cases, however, this specific requirement produced a disproportionate rise in the number of orders received, resulting in a substantial amount of extra work for affected stakeholders. Moreover, it transpired that the description of this requirement was insufficiently precise and too inflexible to accommodate the industry’s extremely diverse product portfolio. The substantial increase in order numbers also threatens to jeopardise timeline compliance, which is crucial to the industry. 

Swissmedic is taking feedback from the industry seriously and is therefore modifying its structure requirements with effect from 13 February 2019. 

Under the modified system, medical devices can be grouped by internationally recognised nomenclature systems, such as GMDN, UMDNS or EDMA. Companies have widely adopted such nomenclature systems. The UDI that will be introduced with the implementation of the MDR/IVDR may also be geared to these systems. 

As before, though, any order for an export certificate must only cover one medical device group. However, the definition of medical device group will change as follows:

Current definition (information sheet section 4.5)  New definition from 13 February 2019 

A group of medical devices constitutes a medical device group if

 

  • the products all originate with the same responsible producer;
  • the products are all covered by the same documentary proof, e.g. EC certificate;
  • the intended use according to the details supplied by the manufacturer in the product information is the same. 

 

 

A medical device group is made up of medical devices that

  • originate from the same responsible manufacturer;
  • re covered by a maximum of one EC certificate (or associated EC certificates); and
  • can be grouped into no more than 20 different product codes (under GMDN, UMDNS, EDMA etc.)

 

Important: All these criteria must be fulfilled. 

A separate order must be submitted for each medical device group. 

The new conditions both expand product groups significantly, while simultaneously making grouping more flexible. Compared with current requirements, the number of orders that have to be submitted for a particular product portfolio is substantially decreased. This, coupled with the lower fees that were introduced on 1 January 2019, will generate substantial cost-savings for the industry. 

By contrast, reviewing more comprehensive applications will increase Swissmedic’s workload. Restricting the number of different product codes to a maximum of 20 will help limit the amount of processing and review work the Agency has to do and thus also help safeguard compliance with timelines. 

Swissmedic reserves the right to review ordering requirements again at a later date, notably in connection with the revision of regulatory norms (MDR/IVDR) in Switzerland. 

The necessary modifications to the order form, business case processing system and all ordering information will take a certain amount of time. It will therefore not be possible to implement the new requirements until 13 February 2019. 

Please also note that one thing will not change: Swissmedic will still only be able to process orders that are both complete and comply with the requirements. Please help us reduce the number of objections we have to issue by making everyone in your organisation who is involved in ordering aware of our requirements.