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Color Additive Petitions

September 24, 2021
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

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Infusion Pumps Safety Assurance

September 24, 2021
Standards

The US Food and Drug Administration (FDA)’s guidance, entitled “Infusion Pumps Total Product Life Cycle” provides assistance to industry in preparing premarket submissions for infusion pumps and to...

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Medical Devices – Asia Regulatory Updates round up – Aug 2021

September 9, 2021
Medical Device

Philippines (FDA) 1. Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical...

2 of Permit to use of Medical Devices, ASEAN Harmonized Technical Requirements, Authorization for a Medical Device, CPAP and BiPAP devices, Guide MDMC Online System, License Applications of Medical Devices, medical device pertaining to Dental, Medical Device pertaining to Obstetrical and Gynecological, medical device pertaining to Pediatrics and Neonatology, medical device pertaining to Urology, Regulation of software based medical devices, Warning to advertisers about test kits

Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021

September 9, 2021
Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

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Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements

September 8, 2021
Medical Device

The fast evolution of medical technology and the essential role of medical devices in the health care delivery system have highlighted the importance of ensuring the safety and effectiveness of these...

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Safety and Performance (SSP) of Class C and D IVDs

September 1, 2021
Standards

The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other...