The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks. Especially, medical devices manufacturers willing to launch their products in the ASEAN geographies have to walk through stringent regulations, as different markets portray different Regulatory requirements.
- February 16, 2021 Medical Devices
- February 9, 2021 Food and Food Supplements, Regulatory Affairs
To streamline the food facility registration for manufacturers in the United States (US), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) has added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the Section 415 of the FD&C Act (21 U.S.C.
- February 9, 2021 Pharmaceuticals, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory Affairs
The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
- February 9, 2021 Medical Devices
The TGA has recently undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG) and identified common areas of non-compliance against claimed standards in this review process.
- February 8, 2021 Medical Devices, Regulatory Affairs
Risk management is an essential process for medical devices to ensure their safety and effectiveness. Medical device manufacturers must have established risk management processes to combat and reduce the risks, by performing thorough risk evaluations.
- February 8, 2021 Medical Devices, Regulatory Affairs
With the EU MDR (European Union Medical Device Regulation) deadline inching closer on May 26th, 2021, it is necessary for the device industry to be aware of the EU MDR 2017/745 regulation for Economic Operators (EOs). As per the regulation, a Manufacturer, an Importer, a Distributor, and an Authorized Representative (AR) are considered as Economic Operators (EOs).
- February 5, 2021 Regulatory Affairs, Regulatory Intelligence
Isn’t it interesting to see Artificial Intelligence (AI) sculpting out to have a thriving position in the Regulatory landscape? One of the most important reasons for this advancement is the ability of AI and Machine Learning (ML) applications to tackle everyday procedural challenges and logical issues that compliance officers put up with.
- February 5, 2021 Regulatory Affairs, Regulatory Intelligence
Sustaining the ever-evolving global Regulatory space of the life sciences industry is strenuous. Therefore, it is necessary for manufacturers to keep abreast with the latest Regulatory information to ensure compliance across all the business functions, such as clinical development, release, and marketing scrutiny of medicines.
- February 5, 2021 Food and Food Supplements, Regulatory Labeling
As you may know, January 1, 2021, has called off the 11-month long post-Brexit transition period. This also marked the deadline for the United Kingdom (UK) based food and beverages manufacturers to implement their product labeling changes.
- February 5, 2021 Chemicals, Regulatory Affairs
Being one of the crucial export sectors of the UK, the Chemicals industry could get hit hard due to Brexit. British companies are already competing with the American and the Asian markets and are under tremendous pressure in battling higher R&D costs.