You may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.
- December 23, 2020 Medical Devices, Compliance, Audit and Validation, Regulatory Affairs
- December 21, 2020 Medical Devices
Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch.
- December 21, 2020 Medical Devices, Regulatory Affairs
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.
- December 21, 2020 Chemicals, Cosmetics Regulatory Services, Regulatory Affairs
Chemical products are used in a variety of sectors in the Life sciences industry. Pharmaceuticals and cosmetics sectors are a few among them.
- December 9, 2020
Ministry of Ecology and Environment (MEE) of China published the revised law for new chemical substances on May 7, 2020, which is said to be replacing the existing legislation, MEP Order 7, from Jan 1, 2021. The new update focuses on the major changes that MEE Order 12 has introduced and their implications for the industry from a legal standpoint. Let us have a brief look at it.
- December 9, 2020 Cosmetics Regulatory Services, Regulatory Affairs
The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. As per the Cosmetic Regulation 1223/2009, a PIF helps the concerned authorities of the European Union (EU) to monitor the safety of cosmetic products available in the market.
- December 9, 2020 Medical Devices, Regulatory Affairs, Regulatory Labeling
e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
- December 9, 2020 Chemicals, Regulatory Affairs
Biocidal Products protect humans, animals and materials against harmful organisms like bacteria. Biocidal product regulation (BPR) aims to ensure a high level of protection for humans and environment and improve the functioning of the Biocidal products’ market in the European Union (EU).
- December 9, 2020 Chemicals, Regulatory Affairs
The European Commission (EC) has provided clarification on the deadlines for updating their REACH registration dossiers. The requirement to update the dossiers ‘without undue delay’ is specified as three (3) months in most cases and up to twelve (12) months in complex cases.
Medical Face Masks and Particulate Respirators - Decode SFDA’s Requirements and Recognized Standards
December 9, 2020 Medical Devices, Regulatory AffairsAs it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.