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Medical Devices › Regulatory Requirements › Licenses

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Hogan Lovells

State Licensing Spotlight – Prescription Medical Device Manufacturers & Distributors: Enforcement and penalties for operating...

Hogan Lovells on

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 6 Of 6)

MoFo Life Sciences on

In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more

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