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.
Over 130 tonnes of medical face masks inspected
06.10.2020
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.
Placing on the market of medical face masks
Procuring medical face masks
Powers of the authorities
Reporting non-conforming medical devices
Placing on the market of medical face masks
Before they can be placed on the market as a medical device, medical face masks must have successfully completed the corresponding conformity assessment procedure (CE marking) according to Art. 10 of the Medical Devices Ordinance (MedDO, SR 812.213).
The following information is essential for medical face masks (Class I non-sterile medical devices):
- Declaration of Conformity in accordance with Directive 93/42/EEC (or Regulation (EU) 2017/745) by the manufacturer or its European authorised representative
- Details of the European authorised representative (EC-REP) on the packaging if the manufacturer is domiciled outside Europe
- Details of the manufacturer on the product (must be identical to the information in the Declaration of Conformity).
- If the product is to be dispensed to the public, the information on the packaging and the text of any package leaflet must be written in German, French and Italian.
Note: The exemption for non-conforming face masks approved by the Federal Council on 29 April 2020 for inclusion in COVID-19 Ordinance 2 only applies to non-medical uses. Such non-conforming masks must not be used for direct patient contact in hospitals or doctors’ surgeries! Since 22 June 2020, such masks must explicitly be labelled as not for medical use
More information on their regulation can be found in the following information sheet
Procuring medical face masks
The information sheet
advises consumers of the specific points that they should consider when purchasing masks.
Specific information and advice on the procurement of medical devices in health institutions is provided in information sheet
Powers of the authorities
Swissmedic and the other authorities entrusted with the implementation of the Therapeutic Products Act (TPA; SR 812.21) may, within their jurisdiction, take all administrative measures necessary to enforce this act (Art. 66 TPA). In particular, they may seize, hold in official storage or destroy therapeutic products which endanger health or which do not conform to the regulations of this Act (Art. 66 para. 2 let. d TPA), and also prohibit the distribution, dispensing, import, export and foreign trade from Switzerland of therapeutic products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage (Art. 66 para. 2 let. e TPA).
Moreover, the customs authorities are entitled to hold back shipments of therapeutic products at the border, in a free port or in a customs warehouse if they suspect that the recipient or sender in Switzerland is in breach of the provisions governing the import, manufacture, placing on the market or export of therapeutic products as regards the contents of the shipment (Art. 66 para. 4 TPA). They may call in the enforcement authorities. The latter shall make any further enquiries and take the necessary measures (Art. 66, para. 5 TPA).
Reporting non-conforming medical devices
Purchasers of medical devices who notice an irregularity (e.g. potentially counterfeit EC certificates) can report their suspicions to Swissmedic. Swissmedic checks reports of suspicions on the basis of the associated risk and takes corrective action, involving other European authorities where necessary.