For the manufacture and import of medical devices, an application shall be filed with the central competent authority for registration and market approval. No ...

The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for ...

An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the ...

This Act provides the requirements for: 1) medical devices and accessories (hereinafter medical devices) and the manufacture thereof; 2) placing on the market ...

This Act regulates the placing on the market, putting into service, making available on the market and distribution, clinical investigations and performance ...

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178 ...

Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the ...

The aim of this Act is to ensure the quality and safety of medical devices, with public safety as the guiding principle, and to ensure that the production, ...

The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for ...

8 февр. 2021 г. · ensuring the putting on the market and/or putting into service medical devices which do not threaten life and health of patients, medical ...