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Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same.
Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices.
While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
Demand for cosmetics is consistently growing, worldwide. All thanks to the online product sale, increased beauty consciousness and younger generation’s lifestyle standards.
Artificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required.
The National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.
A Clinical Evaluation Report (CER) is a safety and performance assessment report of any medical device based on the clinical data related to it. The clinical data is either collected through clinical investigation or by availing previously collected data of a substantially equivalent device.
Be it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user.
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