Art. 82 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Federal government
Legislator summary
AI generatedThe Federal Council and the Agency shall enforce this Act insofar as the Act states that the Confederation is competent to do so. The Agency is the enforcement authority for products specified in Article 2 a. The FOPH is responsible for the enforcement of Chapter 4 Section 2 a. The Federal Council may delegate certain of the Agency’s or the FOPH’s tasks to other authorities. {note: Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).} The Federal Council shall enact the implementing provisions unless this Act states that the Agency is competent to do so, or when it has not allocated the enactment of provisions of a technical nature or of minor importance to the Agency. Insofar as certain delegated acts and implementing acts of the European Commission in the area of medical devices concern technical or administrative details that are regulated on an ongoing basis and generally amended at short notice, the Federal Council may determine that the relevant acts in the version binding for EU member states are also to be applicable in Switzerland. {note: Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 ( AS 2020 2961; BBl 2019 1).}
Art. 82 TPA · Federal government
The Federal Council and the Agency shall enforce this Act insofar as the Act states that the Confederation is competent to do so. The Agency is the enforcement authority for products specified in Article 2 a. The FOPH is responsible for the enforcement of Chapter 4 Section 2 a. The Federal Council may delegate certain of the Agency’s or the FOPH’s tasks to other authorities.
The Federal Council shall enact the implementing provisions unless this Act states that the Agency is competent to do so, or when it has not allocated the enactment of provisions of a technical nature or of minor importance to the Agency.
Insofar as certain delegated acts and implementing acts of the European Commission in the area of medical devices concern technical or administrative details that are regulated on an ongoing basis and generally amended at short notice, the Federal Council may determine that the relevant acts in the version binding for EU member states are also to be applicable in Switzerland.