Suppliers undergo periodic and for-cause inspections by FDA personnel to verify compliance with the Quality Management System Regulation (QMSR, 21 CFR Part 820) and other regulatory requirements. The FDA replaced the Quality System Regulation (QSR) with the QMSR on February 2, 2026, incorporating ISO 13485:2016, thereby making compliance with current Good Manufacturing Practices (cGMPs) in the ISO standard mandatory for medical devices sold in the United States. The FDA inspects both the company's and its suppliers' facilities. Similar inspections and audits are conducted by Notified Bodies, auditing organizations under the Medical Device Single Audit Program (MDSAP), and other regulatory authorities in countries where the products are distributed. Non-compliance may result in enforcement actions such as warnings, recalls, penalties, and other sanctions.
Outside the United States, medical device laws require manufacturing certification and audits through MDSAP, Notified Bodies, or other regulatory inspections. The European Union has adopted the EU Medical Device Regulation (EU MDR), effective May 2021, which imposes stricter requirements than the previous EU Medical Device Directive (EU MDD). New and modified devices must comply with the EU MDR, while devices certified under the EU MDD may continue to be marketed until their certification expires. Certain EU MDR requirements have been effective since May 2021. In February 2023, the EU extended the EU MDR certification deadline to December 2027 for highest-risk devices and December 2028 for lower-risk devices.
Teleflex Incorporated's Comment on Supply Chain
Suppliers undergo periodic and for-cause inspections by FDA personnel to verify compliance with the Quality Management System Regulation (QMSR, 21 CFR Part 820) and other regulatory requirements. The FDA replaced the Quality System Regulation (QSR) with the QMSR on February 2, 2026, incorporating ISO 13485:2016, thereby making compliance with current Good Manufacturing Practices (cGMPs) in the ISO standard mandatory for medical devices sold in the United States. The FDA inspects both the company's and its suppliers' facilities. Similar inspections and audits are conducted by Notified Bodies, auditing organizations under the Medical Device Single Audit Program (MDSAP), and other regulatory authorities in countries where the products are distributed. Non-compliance may result in enforcement actions such as warnings, recalls, penalties, and other sanctions.
Outside the United States, medical device laws require manufacturing certification and audits through MDSAP, Notified Bodies, or other regulatory inspections. The European Union has adopted the EU Medical Device Regulation (EU MDR), effective May 2021, which imposes stricter requirements than the previous EU Medical Device Directive (EU MDD). New and modified devices must comply with the EU MDR, while devices certified under the EU MDD may continue to be marketed until their certification expires. Certain EU MDR requirements have been effective since May 2021. In February 2023, the EU extended the EU MDR certification deadline to December 2027 for highest-risk devices and December 2028 for lower-risk devices.
Sources:
Teleflex Incorporated's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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