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4 Total results for product and free and sample content found

Medtech Insight

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

By Ferdous Al-Faruque 27 Nov 2020

Article

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Topic Approvals Compliance Regulation

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Medtech Insight

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

By Shawn M. Schmitt 27 Nov 2020

Compliance_Corner_Part_1

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

Topic Compliance FDA

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Pink Sheet

China Regulatory Express Former CFDA Commissioner Bi Makes Comeback

By Brian Yang 27 Nov 2020

CFDA China Forbidden City

Ex-China FDA Commissioner Bi Jingquan’s new role, a waiver of bioequivalence testing for hundreds of drugs, data accuracy requirements and a new crackdown on compliance issues.

Topic China Regulation Compliance

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Medtech Insight

MDSAP And USMCA: 3 Ways Mexico Can To Come Up-To-Speed With The Single-Audit Program Targeted By New Free-Trade Accord

By Shawn M. Schmitt 29 Jan 2020

MDSAP_And_USMCA_3_Ways

The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.

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