COVID-19 pandemic — Switzerland takes part in "Operation Stop"
Bern, 06.10.2020 - Over 130 tonnes of medical face masks inspected The Federal Customs Administration (FCA) and Swissmedic have taken part in a coordinated global campaign to combat the trade in illegal drugs and medical devices. Increasing numbers of counterfeit and inferior quality products have entered into circulation since the start of the COVID-19 pandemic. In connection with the campaign, FCA and Swissmedic have inspected 29 shipments with a total of 132 tonnes of medical face masks.
The World Customs Organization (WCO) coordinated the international "Operation STOP", which took place between 11 May and 12 July 2020. Authorities from a total of 99 countries took part in the operation.
Focus on medical face masks
Since the outbreak of the COVID-19 pandemic, the proportion of non-conforming or only ostensibly conforming medical face masks has increased substantially, also on the Swiss market.
Swissmedic therefore decided to focus on these medical devices in the campaign.
In Switzerland, customs and Swissmedic together inspected 29 shipments of medical face masks. This corresponds to over 34.2 million masks weighing a total of 132 tonnes. 10 of the 29 shipments contained demonstrably non-conforming medical face masks.
The operation focused on the control of shipments intended for healthcare institutions such as hospitals. In particular, large shipments (with a million items or more) that had been ordered by commercial operators were inspected during the campaign. These shipments were first checked to establish whether the required information was present on the packaging and, if applicable, on the product information. Where necessary, Swissmedic subsequently demanded additional documentation to establish the conformity of the medical face masks.
The following non-conformities (deficiencies) were noted:
- No conformity marking (CE mark) on the packaging
- No address of the European authorised representative (EC-REP) on the packaging
- Other incomplete or incorrect presentation of required information on the packaging
- Information on the packaging not presented in three languages (DE, IT, FR; this requirement does not apply if the items are to be delivered to professionals)
- Lack of evidence confirming that the requirements of standard EN 14683 are satisfied (missing test results).
- Tests according to standard EN 14683 not conducted in an accredited test laboratory.
Swissmedic subsequently decided to initiate five administrative proceedings. One administrative proceeding resulted in a ban on the placing on the market of face masks for medical use. Two further proceedings led to the granting/checking of an exemption according to COVID-19 ordinances. Two proceedings were concluded by Swissmedic without further measures after the situation was clarified (no medical use).
The results of the operation showed that fairly large quantities of non-conforming medical face masks were circulating on the Swiss market.
Address for enquiries
Swiss Agency for Therapeutic Products
+41 58 462 02 76