A new system for issuing Export Certificates (FSC) and Manufacturing Certificates (MC) for medical devices in Switzerland

15

Aug 2018

For decades, Swissmedic has issued Export Certificates and attestations for the Swiss export industry. Recently, the number of orders and the time spent processing each order have steadily increased. Countermeasures are required in order to maintain current timelines in the medium term.

Following an in-depth analysis of the processes, the service has been thoroughly 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.

The main characteristics of the new process are:

  • Revised product portfolio: one type of Export Certificates (FSC) and one type of attestation (Manufacturing Certificates)
  • The scope of services specified in a Service Agreement (SA), which aims to present the scope of services and the preconditions for the provision of services in a clear and transparent manner. Furthermore, it describes the services provided by Swissmedic related to the issuing of Export Certificates and Manufacturing Certificates (attestations). It also explains the entitlements and obligations of the persons who make use of this service
  • Precise requirements for the structured submission of supporting documents and product lists
  • Active PDF order form that updates dynamically during completion
  • Wholly overhauled information, instructions and guidance
  • Electronic submission of the order form, supporting documents and product lists via the Swissmedic Portal
  • Export Certificates (FSC) and certifying documents sent to the applicant only
  • Fee adjustment on 01.01.2019, when the new Therapeutic Products Fees Ordinance (FeeO) comes into force

The new system will be launched on the 17th of September, 2018. From this date, Swissmedic will accept the first orders under the new process. However, there will be a transitional period lasting until the 19th of October 2018, during which the current system will be simultaneously active.

See the full report in English (change to Italian, French or German in the top-right corner) here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

31

May 2019

Between the 3rd of June and the 15th of July, SwissDRG will be receiving the requests/suggestions regarding the DRG system in the country.

Read more

29

May 2019

The report includes all published reimbursement decisions for IVD tests in 2018 in European countries with established frameworks for out-patient reimbursement laboratory tests (Belgium, France, Germany, Netherlands, Switzerland).

Read more

28

May 2019

The report includes an overview of funding framework and all (as of May 2019) decisions from ultimate payers and decisions makers in England (NHS England, one CCG), Germany (G-BA), Netherlands (Zorginstituut Nederland), Norway (“New Methods” framework) and Switzerland (Federal Office of Public Health). More than 1000 decisions are included.

Read more

25

Apr 2019

The Swiss innovation agency, InnoSuisse, reminds that the deadline for the application for financing of truly innovative projects is May 20, 2019. The Swiss Federal Council has ensured additional funding of CHF 24 million for 2019 and 2020 for the “Impulse digitalization programme.”

Read more

11

Apr 2019

On March 15, 2019, the Swiss Medical Board published two appraisal reports: “Robot-assisted laparoscopic surgery versus open surgery for radical prostatectomy” and “Robot-assisted laparoscopic surgery versus conventional laparoscopic surgery for simple or radical hysterectomy.”

Read more

19

Mar 2019

In February 2019, the entity that is in charge of the DRG system in Switzerland, SwissDRG, announced the publication dates of the SwissDRG 9.0/2020 catalog, but also information that concerns the suggestions regarding SwissDRG.

Read more

15

Mar 2019

In mid-February 2019, the Swiss conference of cantonal healthcare directors (GDK/CDS) has published information about allocation of hospitals for highly complex visceral surgery in the fields of oesophageal, pancreatic and hepatic resections.

Read more

11

Mar 2019

On February 5, 2019, the Federal Department of Home Affairs (FDHA) decided that in case of suspected infection or fever of unknown origin, positron emission tomography (TEP) will be considered mandatory services. Also, percutaneous electrical stimulation of the posterior tibial nerve (PTNS) was approved for incontinence indication. Furthermore, the reimbursement amounts relating to incontinence and ostomy materials will be reduced. List of Analyses was also updated.

Read more

21

Jan 2019

Curafutura, an association of health insurance companies in Switzerland, started the initiative to change the current outpatient pricing structure (TARMED) in 2016. In late 2018, they let the public know that the new tariff structure for ambulatory medical benefits is almost ready to be submitted to the Federal Council.

Read more

16

Jan 2019

The Federal Statistics Office has published, in late December 2018, the changes regarding procedure coding that would come into force in January 2019. The changes concern CAR-T cell therapy and intervertebral arthrodesis devices, among other treatment methods. Besides the changes implemented, the list of all requested changes in 2018 was published.

Read more

11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

Read more

08

Jan 2019

On December 14, 2018, the Center of Competence and Coordination of Confederation and Cantons, Swiss eHealth, has published version 2.0 of the Swiss eHealth strategy. This version replaces the 2007 version and will be applied until 2022. With the "Swiss eHealth Strategy 2.0", the Confederation and the cantons intend to enhance the promotion of digitalization in the healthcare sector, whose priority is the introduction and dissemination of the patient's digital record.

Read more

03

Jan 2019

On November 30, 2018, the DRG-regulating body in Switzerland, SwissDRG, has notified the public that the tariff version of SwissDRG 8.0/2019 has been published.

Read more

11

Dec 2018

On November 15, 2018, the Swiss Federal Statistics Office (UFS) has notified the public that the CHOP version 2019 and ICD-10-GM version 2018 were published.

Read more

03

Dec 2018

On 13th of November, 2018, one of the Swiss insurers’ association, curafutura, announced on their website that the new benefit structure, which will be the basis for the new fee structure in ambulatory settings, is ready. The company ats-tms SA prepared this benefit structure.

Read more

25

Oct 2018

In mid-September 2018, the Swiss Federal Council has placed in consultation the first group of actions that are intended to contain costs in the healthcare sector. The suggested measures will be discussed with all relevant healthcare stakeholders (tariff partners, Cantons, industry and patient associations). These measures should save hundreds of millions of Swiss francs in the long term.

Read more

23

Oct 2018

Explanation about the coding of CAR-T cell therapy in Switzerland was released by SwissDRG.

Read more

16

Oct 2018

The board of directors of the entity that runs and manages the Swiss DRG system, SwissDRG SA, decided to verify the conditions necessary for the foundation of the outpatient tariff agency in late September 2018.

Read more

08

Oct 2018

On the 3rd of September 2018, an association of 4 Swiss health insurers, curafutura, published their opinion on the proposed reform of payment mechanism for inpatient and outpatient services.

Read more

04

Oct 2018

On 13th of August, 2018, the association of Swiss insurers, santésuisse, published an announcement in which they state that the control of the invoices received saves the premium payers’ costs up to CHF 3 billion.

Read more

02

Oct 2018

On 24th of August, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that the planning version of SwissDRG (version 8.0 (2018/2019)) and the planning version of TARPSY (version 2.0 (2018/2019)) have been published.

Read more

12

Sep 2018

Clarifications about coding of CytoSorb procedure and use of Flow Diverter in Switzerland were released by SwissDRG.

Read more

10

Aug 2018

In April 2018, a national HTA program has been launched in order to re-evaluate benefits presently covered by the mandatory health insurance.

Read more

09

Aug 2018

On June 29th, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that The planning version of SwissDRG (version 8.0 (2017/2019)) and the planning version of TARPSY (version 2.0 (2017/2019)) have been published.

Read more

26

Jul 2018

At the beginning of June 2018, the Federal Department of Home Affairs published an update of the Services Ordinance (Ordinanza sulle prestazioni, OPre). This update concerns many different fields, including the list of laboratory tests.

Read more

24

Jul 2018

On 8th of June 2018, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalogue version of Swiss DRG 8.0/2019.

Read more

20

Jul 2018

On 18th of June, 2018, the Federal Department of Home Affairs issued the latest update of the list of medical aids and equipment. This update will come into force on 1st of January, 2019. However, this list will be updated a few times in 2018.

Read more

16

Jul 2018

Starting with 19th of June, 2018, HIV self-test kits can be bought in pharmacies and druggists all over Switzerland.

Read more

04

Jul 2018

A change in the Services Order (Ordinanza sulle Prestazioni, OPre), regarding surgery in general, will come into force on January 1st, 2019. This change makes it possible to reimburse a number of surgeries in hospital settings in exceptional circumstances because in general, these procedures should be performed in out-patient settings.

Read more

20

Jun 2018

On 28th of May, 2018, the Swiss Medical Tariff Commission (CTM-MTK) has agreed with the hospitals association (H+) on a transitional solution for the application of TARMED, which will last until July 31st, 2018.

Read more

13

Jun 2018

The list of the laboratory tests is based on the Services Order (Ordinanza sulle Prestazioni, OPre) of the September 29th, 1995; the latest update is in force since January 1st, 2018. The list contains the services whose costs are covered by the obligatory healthcare insurance (assicurazione obbligatoria delle cure medico-sanitarie, AOMS). With the latest update, there are 1931 tests on this list.
See the list of the January 2018 modifications in Italian here.
See the full list of current laboratory tests in Excel format (in French, German and Italian) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Read more

01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

Read more

10

May 2018

Between 28th of May and 9th of July 2018, SwissDRG will be accepting the requests/suggestions regarding the DRG system in the country.

Read more

20

Apr 2018

On 5th of April, 2018, the Board of Directors of SwissDRG SA has given the director the mandate to establish, where appropriate, codifications by analogy in agreement with the Federal Statistics Office (FSO). The regulation from April of 2018 covers CytoSorb for removal of cytokines.

Read more

16

Apr 2018

In February 2018, the DFI (the Federal Department of Home Affairs) has decided to make a change in the activity order (Ordinanza sulle prestazioni, OPre) concerning “out-patient before in-patient.” The modification is coming into force starting January 1st, 2019. Six procedures will be reimbursed only in out-patient settings.

Read more

10

Jan 2018

The Department of Home Affairs (EDI) in Switzerland decided upon the coverage with evidence development (CED) of two types of positron emission tomography as well as stereotactic radiotherapy (photons) of exudative age-related macular degeneration. The status is given to contested medical services for a specific period which is extended until evidence is complete.

Read more

27

Dec 2017

The further-developed tariff structure SwissDRG was approved by the Federal Council in Switzerland. The new tariff version for inpatient services will be effective from January 1st in 2018. The tariff structure SwissDRG defines how inpatient services in the acute care area of the hospitals and birthplaces are reimbursed within the framework of compulsory health care insurance in Switzerland.

Read more

08

Nov 2017

An international advisor group of 14 medical and health economic experts proposed 38 measures of how control the increase of healthcare costs in Switzerland. One third of the actions including the strengthening of HTA are already considered. The Swiss Federal Council now wants to develop concrete plans for the implementation of the new measures suggested in the report by the expert group, including global budgets for the outpatient sector, the introduction of medical boards, the encouragement of parallel imports of medical technology and implants and annual review of prices.

Read more

25

Jul 2017

SwissDRG has released overview of planned update of DRG system (version 7.0) in 2018, including list of preliminary approved add-on reimbursement categories. Add-on will be established for endobronchial valves, proton therapy, autologous matrix-induced chondrocyte implantation at knee joint and intermitted hemodialysis for removal of proteins with molecular mass up to 60,000 Da.

Read more

21

Apr 2017

SwissDRG has released the application form for suggestions for DRG change in 2017. Applications will be collected between 29th of May and 10th of July 2017. Approved changes will be implemented in 2019.

Read more