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China State Council Releases Order 739, Creating New Market Access Opportunities for Global Medical Device and IVD Manufacturers

China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices (or State Council Order Number 739) on February 9, 2021.

MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5).

New Guidance: Classification of IVD under the IVDR

On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union.

UKCA: A Wait and Watch Approach?

On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

The IVDR Compliance Roadmap: From Start to Finish

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

IVD Clinical Trials in the Era of COVID-19: Time to go Virtual?

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)

China initiated its highest level of emergency response to the COVID-19 outbreak (also referred to as the novel Coronavirus) on 20 January 2020.

Key Requirements of Post-Market Surveillance under IVDR

As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in 2022, there are many significant changes that IVD manufacturers must consider from a risk management perspective, as well as those pertaining to Post-Market Surveillance (PMS) to meet compliance.

IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand

The European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC), introduces risk–based classification for IVD devices, in addition to new and required Technical Documentation. Specifically, the seven (7) classification rules under the IVDR have resulted in four (4) new risk groups for IVD products, which determine … Continued

Three Essentials for Smart IVD Clinical Trial Design

When designing an In Vitro Diagnostic (IVD) clinical trial, there are three major areas that must be considered if manufacturers are to achieve optimal, accurate outcomes: Biostatistics Clinical research conduct Data management While these three clinical research disciplines are interdependent on one other, equal attention should be paid to each of these functions, as outlined … Continued

NAMSA® Launches “Uniquely IVD” Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, announced today the launch of its in vitro diagnostic (IVD) development business to provide global manufacturers a proven resource for expedited commercialization outcomes delivered via NAMSA’s “Uniquely IVD” … Continued