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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...

ANSM publishes a preventive management, distributors, FDA Conduct of Clinical Trials of Medical Products, FDA Export Certification, first certification for that type of device, generating devices under the Pest Control Products Act, Guidance for notified bodies, Medical Devices Regulatory Updates, MHRA shared guidance for manufacturers of devices, SARS-CoV-2 in vitro diagnostic medical devices

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...

asean harmonized technical, authorization of medical devices, harmonization technical, Medical Devices

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...

ICH: Guideline on Testing for Carcinogenicity of Pharmaceuticals, an Addendum

August 30, 2021
Biopharma

Over the course of drug development, it is important for sponsors to develop a scientifically robust strategy for carcinogenicity assessment that considers key biologic, pharmacologic, and toxicologic...

Addendum, Guideline on Testing for Carcinogenicity, Pharmaceuticals, Testing for Carcinogenicity of Pharmaceuticals

Regulatory Changes for Software Based Medical Devices in Australia

August 20, 2021
Medical Device

The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including software that functions as a medical device in its own right, and software that controls or interacts...

Medical device labelling requirements, regulatory guidance, Software as a Medical Device, Software Based Medical Devices in Australia, Therapeutic Goods Administration (TGA)