The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance
FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
Indonesia: A look at Indonesia’s Halal Product Law
Indonesia’s Halal Product Law Criteria and a review of the halal global market and foreign company halal accreditation process
ISO revises guidelines to address the risk management of medical devices
Overview: On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as, software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some […]
QMS Implementation for Class I Devices Under EU MDR
OVERVIEW The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone […]
ANVISA -RDC 305/2019- Regulation for Custom-Made Medical Devices
On October 2019, Anvisa published its formal regulations for custom-made medical devices “RDC 305/2019. “
FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016
By 2020, the Food and Drug Administration (FDA) is planning to change its quality system requirements for medical device manufacturers stipulated in 21 CFR 820 by ISO 13485 :2016. This decision was taken as more and more regulators are looking toward adopting globally harmonized requirements that utilize regulations as well as standards, such as ISO […]
A review of the changes in ISO 13485
On February 25, 2016, the International Organization for Standardization (ISO) published its revisions to ISO 13485 replacing the previous version from 2003. This is the global standard for medical device quality management systems (QMS). Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition […]