Medical device registration in Saudi Arabia: Saudi Arabia is a monarchical state with large oil reserves and is one of the leading members of OPEC. It is an oil-based economy and the government controls most major economic activities. Due to the low oil prices, the government is focusing on expanding its healthcare, education, nuclear, construction, …

Medical Device Registration in Saudi Arabia阅读更多 ”

Manufacturers of combination products were offered a list on Tuesday of adaptable components that can be utilized to agree to the FDA US (Food and Drug Administration’s) necessities for Good Manufacturing Practices(GMP).The proposal satisfies a mandate from the 21st Century Cures Act of 2016 that approached FDA to periodically issue a rundown recognizing the types of combinations …

FDA Proposes Mechanisms to Comply with GMP’s Requirements阅读更多 ”

Recently, the US FDA (Food and Drug Administration) published two guidances which its intended use was to clarify its strategies on communicating (Medical Product Communications) the medical product data to payors and to inform the industry on the best way to convey data about products in a reliable way with FDA-required labelling. This guidance shows …

FDA Releases Draft Guidance for Medical Product Communications | Labeling阅读更多 ”

这是FDA对医疗设备软件的关注的最新举措，该动作始于2002年，该机构发布了有关软件验证的指南。从那时起，医疗设备中软件的利用已经扩展并变得更加复杂。FDA已转向…

FDA专注于医疗设备安全|网络安全阅读更多 ”

Central Medical Device Testing Laboratory Central Government designates laboratories as Central Medical Device Testing Laboratory under MDR, 2017. These laboratories are being set up to provide a boost to the domestic manufacturing sector by providing adequate infrastructure for device testing based on project proposals and technical support given by the National Health Systems Resource Centre (NHSRC), a …

CDSCO Designates Laboratories as Central Medical Device Testing Laboratory | MDR阅读更多 ”

An industry that export medical devices in India, esteemed at USD 4.9 billion, is moderately little yet has seen unprecedented development over the last few years. Developing at a CAGR of 17% over the last five years, the segment is relied upon to keep witnessing double-digit development with a CAGR of 15% in the coming …

How to Export Medical Devices in India阅读更多 ”

MDUFA IV Changes The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance giving device makers an overview of the types of feedback and meetings they can request during pre-submission phase as part of the agency’s Q-submission program. The draft guidance is meant to update and replace the agency’s recently finalized Requests for …

FDA Updates Guidance for MDUFA IV Changes阅读更多 ”

监管途径The regulatory pathway includes workers who combine technical or industry knowledge rules and regulatory systems to monitor regulations that look towards the safety of public health and the environment. FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services, and also a federal executive …

新医疗设备的最佳监管途径阅读更多 ”