New system for issuing Export Certificates (FSC) and Manufacturing Certificates (MC) for medical devices
Announcement about upcoming changes relating to the issuing of Export Certificates (FSC) and Manufacturing Certificates (MC)
Drawing on the results of a fundamental analysis of the process, Swissmedic is completely overhauling the way it issues Export Certificates and Manufacturing Certificates for medical devices. One innovation is the submission of the documents electronically via the Swissmedic Portal.
The new system will be rolled out on 17 September 2018. From this date, Swissmedic will accept the first orders according to the new process.
For the current system, there will be a transitional period lasting until 19 October 2018.
For decades, Swissmedic has issued Export Certificates and attestations for the Swiss export industry. In recent years the number of orders and the time spent processing each order have steadily increased. Unless countermeasures are taken it will no longer be possible to maintain current timelines in the medium term.
Following an in-depth analysis of the processes, the service has been completely redesigned. This redesign has also taken account of the new technical resources that were recently made available to the Medical Devices Division including, in particular, the use of the Swissmedic Portal for electronic order submission.
New service agreement
The new "Service Agreement for the issuing of Export Certificates and Manufacturing Certificates" aims to present the scope of services and the preconditions for the provision of services in a clear and transparent manner. It describes the services provided by Swissmedic in connection with the issuing of Export Certificates and Manufacturing Certificates (attestations). It also describes the entitlements and obligations of the persons who make use of this service.
The main features of the new process are as follows:
- Revised product portfolio: one type of FSC and one type of attestation
- Scope of services specified in a Service Agreement (SA)
- Clear requirements for the structured submission of supporting documents and product lists
- Active PDF order form that updates dynamically during completion
- Completely overhauled information, instructions and guidance
- Electronic submission of order form, supporting documents and product lists via the Swissmedic Portal
- FSC and certifying documents sent to applicant only
- Fee adjustment on 01.01.2019, when the new Therapeutic Products Fees Ordinance (FeeO) comes into force.
Introduction of the new system
The new system will be launched two and a half months after this announcement, on 17 September 2018. From this date Swissmedic will accept the first orders under the new process.
There will be a transitional period lasting until 19 October 2018, during which the current system will be simultaneously active.
All orders submitted up to this date will be processed under the current system. After this date, only the new order process will apply.
Comprehensive explanatory documents will be made available for the launch, as will a regularly updated FAQ list. A short video guide will show the individual steps involved in the electronic submission of order documents via the Swissmedic Portal.
Swissmedic plans to publish an English-language explanation on its website in due course for the information of recipient countries of Export Certificates and attestations.
To assist you in your in-house preparations, all the required information and new documents will be published on the Swissmedic website one month before the actual launch.
Questions & answers
Will FSC that have already been delivered but not yet used now be invalid?
Why will the time limit of 30 days not be shortened?
No, all FSC will remain valid until the date printed on them.
Can FSC also be ordered for medical devices that conform to the new EU MDR/IVDR Regulations?
Swissmedic will initially leave this time limit unchanged. Since all orders will be delivered promptly, it may be possible to shorten the delivery times if the order volume remains low. During the introductory phase, however, the time limit may occasionally be exceeded in some cases. If, in the medium term, a shortening of the time limit seems feasible, Swissmedic will communicate this fact accordingly and adapt the Service Agreement.
How much will an FSC cost during the introductory phase? Why do the new fees not apply until 01.01.2019?
Yes, this is still possible in principle, subject to submission of appropriate evidence proving their conformity. At present this is only possible in Switzerland for Class I medical devices or Class A IVD.
However, mixed product lists – i.e. one list grouping together devices according to the Directives and devices according to MDR/IVDR – will not be accepted. Please submit separate orders in such cases.
Is forwarding for certification by the Federal Chancellery or the Consular Service Worldwide (CSW) possible?
To take account of the portfolio revision and the new submission structure, the fee for each Export Certificate will be CHF 200 as of the entry into force of the new Therapeutic Products Fees Ordinance on 1 January 2019. The fee specified for attestations (time-spent basis) remains unchanged.
The Fees Ordinance is being revised as part of the HMV IV package of ordinances, which will take legal effect on 1 January 2019 after ratification by the Federal Council. Until then, the current Therapeutic Products Fees Ordinance still has to be applied. The Agency has leeway in this matter. The new fees will be applied to all orders received after 1 January 2019
How must replies and supplementary submissions – e.g. due to complaints regarding export certificates – be sent?
The export certificates and manufacturing certificates are delivered only to the address of the requesting company. Swissmedic will not forward them to third parties. Therefore, if you want legalization of the signature you have to send the final FSC to the Federal Chancellery and / or Consular Service Worldwide CSW GmbH in Bern for additional legalization by the embassy or consulate in Switzerland.
Further information on legalizations can be found on the website of the Swiss Federal Chancellery or on the website of the CSW.
Which deadlines apply for in case of complaints by Swissmedic?
All replies and supplementary submissions regarding export certificates must be sent via Swissmedic’s eGov eMessage service. To do so, please select delivery type “Response to Swissmedic correspondence”. It is also important to state the Swissmedic reference no. (102xxxxxxx) under “Reference to original application number”.
Why it’s not possible to scan the application form and submit it electronically via the eGov Service eMessage?
According to para. 2.3.4 of the Service agreement for export certificates the Agency requires a processing time of 30 days from the date on which all the information and documents needed to provide the service are present. The deadline ends after the certificate has been sent to the applicant.
This means that in case of complaints the date of application submission is no longer relevant to determine the deadline for processing the application. The deadline of 30 days starts as soon as all deficiencies are rectified and all documents requested for the application are available to Swissmedic. The date of the last submission via the eGov Service eMessage (“Acceptance of Delivery”) can be used as date of reference.
The information contained in the application form is imported as XML format in the business case processing system of Swissmedic. Scanned application forms generate technical problems as the information contained cannot be identified and read from the system. As a consequence, these applications cannot be processed and will be rejected.
Division medical devices
Preview of forms and instructions (valid from 17.09.2018)
Last modification 05.07.2018