Cut through the noise of regulatory updates and stay ahead with the some of the most impactful news from around the globe—handpicked and analysed just for you.
Each week, we dive into some of the key regulatory announcements that matter most to your industry, whether it's medical devices, IVDs, SaMD, pharmaceuticals, or biotech. But we don't stop there. Our AI-driven insights break down why these updates will shape the market and how they could impact your compliance strategy.
As a bonus, check out our Global Index, where we track and tally regulatory updates across continents, giving you a snapshot of how active the global landscape is each week.
Powered by Hoodin’s comprehensive surveillance of 122 countries, this is your one-stop resource for staying informed, staying compliant, and staying ahead.
Global Regulatory Index: Oct 7 - Oct 13, 2024
For the week, Hoodin tracked 73 important regulatory news items from around the world, reflecting the fast-paced changes in the life sciences sector. Our platform covers a broad spectrum of updates, including guidances, policy changes, and new projects, ensuring you're always in the know.
To keep the focus on high-impact updates, we exclude routine items like recalls, field notices, market authorisations, and enforcement actions, ensuring a concise view of the most relevant regulatory movements.
Want insights tailored to your company and product? Login and customise your monitoring to stay informed on the news that matters most to you.
Overview - Top Picks Week of Oct 7th - Oct 13th
This week we recognised 4 news that we recommend you pay attention on.
South Africa Enforces New Pharmaceutical Compliance Deadlines
Africa | Pharmaceuticals
India becomes affiliate member of International Medical Device Regulators Forum
Asia | Medical Devices
Voting result REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (Cyber Resilience Act (CRA))
Europe | Medical Devices | IVDs
CISA Adds Three Known Exploited Vulnerabilities to Catalog
North America | Medical Devices | IVDs | Pharmaceuticals
1. South African and Australian health product regulators to share regulatory information and expertise
Africa | Medical Devices | IVDs | Pharmaceuticals
Pretoria, South Africa and Canberra, Australia, 07 October 2024 –The South African Health Products Regulatory Authority (SAHPRA) and the Australian.. Read full article
SAHPRA - South Africa • Published 7 Oct 2024
AI SUMMARY AND INTEPREATIONS
Executive Summary:
On October 7, 2024, SAHPRA (South Africa) and TGA (Australia) signed an MoU to enhance collaboration in regulating medical products and therapeutic goods.
The agreement focuses on data sharing for product assessment, safety monitoring, and post-market surveillance.
Both regulators aim to improve efficacy, safety, and quality standards through shared expertise.
Interpretation for Companies Selling in South Africa:
Faster approval process: Products approved by TGA may benefit from quicker assessments in South Africa.
Increased post-market scrutiny: Expect stronger focus on pharmacovigilance and adverse event reporting.
Regulatory alignment: Consider aligning regulatory strategies across both regions to take advantage of streamlined processes.
This summary was generated using Hoodin,, which leverages AI to interpret, summarise and translate global regulatory news.
2. India becomes affiliate member of International Medical Device Regulators Forum
Asia | Medical Devices
India has become an affiliate member of the International Medical Device Regulators Forum (IMDRF), marking a significant step toward global collaboration in the medical device regulatory landscape. Read full article
Business North East • Published 3 Oct
AI SUMMARY AND INTEPREATIONS
Executive Summary:
On October 3, 2024, India became an affiliate member of the International Medical Device Regulators Forum (IMDRF).
This membership enhances global collaboration and aligns India’s regulatory framework with international standards.
Interpretation for Companies Selling in India:
Enhanced global cooperation: Expect increased collaboration opportunities with international regulatory authorities, which may streamline the approval process.
Alignment with global standards: Companies can anticipate India’s regulatory framework evolving to match international norms, boosting competitiveness.
Market access: Affiliate membership may open doors for easier market entry and acceptance of products previously approved in IMDRF member countries.
Stay updated on regulatory changes from India’s Central Drugs Standard Control Organisation (CDSCO) as they align with IMDRF standards.
This summary was generated using Hoodin,, which leverages AI to interpret, summarise and translate global regulatory news.
3. Voting result - Cyber Resilience Act (CRA)
Europe | Medical Devices | IVD | Pharmaceuticals
The European Union Council has officially adopted the Cyber Resilience Act (CRA) which will introduce EU-wide cybersecurity requirements for products with digital elements.
From smart doorbells and speakers to baby monitors, the regulation will apply to all products that are connected either directly or indirectly to another device or network.... Read full article
EUR-Lex • Published 7 Oct 2024
AI SUMMARY AND INTEPREATIONS
Executive Summary:
The CRA aims to create a coherent cybersecurity framework, ensuring that IoT products are secure throughout their supply chain and lifecycle.
Products will need to comply with design, development, and production standards, marked by the CE certification, indicating adherence to high safety and health standards.
Certain products, such as medical devices and aeronautical products, may be exempt if they already comply with existing EU cybersecurity laws.
Interpretation for Companies Selling in the EU:
Compliance requirement: Companies must ensure their digital products meet the new cybersecurity standards outlined in the CRA to be sold in the EU.
Timeline for compliance: The CRA will come into force 20 days after its publication, with a 36-month compliance period; early provisions may apply sooner.
Market implications: Companies producing connected devices should assess their products against the CRA requirements to ensure a seamless entry into the EU market.
Monitor changes: Stay informed about the implementation timeline and any additional requirements that may arise as the legislation is finalised. This summary was generated using Hoodin,, which leverages AI to interpret, summarise and translate global regulatory news.
4) CISA Adds Three Known Exploited Vulnerabilities to Catalog
North America | Medical Devices | IVDs | Pharmaceuticals
CISA has added three new vulnerabilities to its Known Exploited Vulnerabilities Catalog, based on evidence of active exploitation.... Read full article
Cybers security & Infrastructure Security Agency (CISA) • Published 9 Oct
AI SUMMARY AND INTEPREATIONS
Executive Summary:
The Cybersecurity and Infrastructure Security Agency (CISA) has added three new vulnerabilities to its Known Exploited Vulnerabilities Catalog, which pose significant risks:
CVE-2024-23113: Fortinet Multiple Products Format String Vulnerability
CVE-2024-9379: Ivanti Cloud Services Appliance (CSA) SQL Injection Vulnerability
CVE-2024-9380: Ivanti Cloud Services Appliance (CSA) OS Command Injection Vulnerability
These vulnerabilities are particularly concerning as they can be exploited to gain unauthorized access or disrupt operations, posing risks to data integrity and patient safety in the life sciences sector.
Binding Operational Directive (BOD) 22-01 mandates that Federal Civilian Executive Branch (FCEB) agencies address these vulnerabilities promptly to safeguard sensitive health information.
While BOD 22-01 targets federal agencies, CISA strongly recommends that all organisations, especially in life sciences, prioritise remediation of these vulnerabilities as part of their cybersecurity measures.
Interpretation for Life Science Companies:
Patient Safety Focus: Address these vulnerabilities urgently to protect patient data and ensure compliance with regulations such as HIPAA.
Regulatory Compliance: If your company works with federal agencies or falls under FDA regulations, ensure you are compliant with BOD 22-01 to avoid potential penalties.
Robust Cybersecurity Practices: Implement and maintain comprehensive vulnerability management protocols to address known exploited vulnerabilities effectively.
Supply Chain Security: Collaborate with vendors (like those using Fortinet and Ivanti products) to ensure they are also remediating these vulnerabilities, protecting your supply chain and overall operations.
This summary was generated using Hoodin, which provides AI-driven interpretations of regulatory news and updates.
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