Ich Guidelines For Medical Devices

ICH Guidance Documents | FDA

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents

This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of...

ICH Official web site : ICH

https://www.ich.org/

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory …

ICH Official web site : ICH

https://www.ich.org/page/ich-guidelines

Safety Guidelines ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough …

ICH Official web site : ICH

https://www.ich.org/page/quality-guidelines

ICH Official web site : ICH

https://www.ich.org/page/meddra

MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

Regulations: Good Clinical Practice and Clinical Trials

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

Part 601 – Applications for FDA Approval of a Biologic License New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New …

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 …

https://www.barnettinternational.com/web-seminars/good-clinical-practice-(gcp)-for-medical-devices-ich-gcp-and-iso-14155

Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, …

Code of Federal Regulations (CFR) | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr

Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of …

Combination Products Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/combination-products-guidance-documents

Evaluation of Devices Used With Regenerative Medicine Advanced Therapies - 02/2019 Selection of the Appropriate Package Type Terms and …