Regulatory Strategy https://www.ddismart.com DDi Mon, 17 Mar 2025 09:21:55 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 https://www.ddismart.com/wp-content/uploads/2024/08/cropped-DDi-512-32x32.png Regulatory Strategy https://www.ddismart.com 32 32 Global UDI updates in recent months https://www.ddismart.com/blog/global-udi-updates-in-recent-months/ Mon, 17 Mar 2025 09:16:08 +0000 https://www.ddismart.com/?p=10196 Staying up to date with Unique Device Identification (UDI) regulations is crucial for global compliance. Various regulatory agencies, including the TGA, ANVISA, NMPA, and the European Commission, have recently introduced significant updates to UDI requirements. Our latest insights highlight key changes that could impact your compliance strategy.

Country UDI Requirements Recent Updates
Australia (TGA) 2022 Jun – AUSUDID sandpit (beta) general use, testing On November 27, 2024, TGA deployed a significant enhancement package to the AusUDID Pre-Production environment. The Pre-Production version is now open again for sponsor use and feedback.Machine-to-Machine (M2M) submissions are still being tested.
2023 Jan – Regulations and Guidance in effect As of 12th December 2024, the Therapeutic Goods Administration (TGA) has published the draft guidance document titled Complying with the Unique Device Identification regulations for medical devices for external review.

Need expert support for UDI compliance? Ensure smooth implementation and adherence to the latest regulations explore our UDI Solutions.

Brazil 2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data reported to RNI by healthcare provider On January 10, 2022, Brazil’s National Health Surveillance Agency (ANVISA) implemented the Unique Device Identification (UDI) system through Resolution RDC 591/2021. This regulation mandates that certain high-risk medical devices, including coronary artery stents and hip and knee arthroplasty implants
2021 Feb – UDI System Publication ANVISA has revised its UDI regulations through RDC 884/2024, an amendment to RDC 591/2021, which became effective on June 1, 2024. This amendment revised specific provisions, including the deadlines and requirements for attributing and affixing UDI
China GS1, ZIIOT and AHM. GS1, ZIIOT and AliHealth.
European Union Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times. The EUDAMED UDI/DEV module will become mandatory 6 months after its functionality is confirmed in the OJEU. EUDAMED UDI module has been available for voluntary use since October 2021.
  • Devices already on the market must be registered within 12 months after the module’s functionality is confirmed.
  • New devices (excluding custom-made, investigational, and performance study devices) must be registered in the UDI/DEV module before placing the first sales unit on the market after the mandatory use date

As UDI regulations continue to evolve worldwide, ensuring compliance with the latest updates is essential. Stay ahead of regulatory changes and streamline your UDI implementation with expert guidance. Contact us to navigate the complexities of UDI compliance efficiently.

]]> Regulatory Impact Assessment; How are you handling this currently? https://www.ddismart.com/blog/regulatory-impact-assessment-how-are-you-handling-this-currently/ Fri, 05 Apr 2024 05:01:16 +0000 https://www.ddismart.com/?post_type=blog&p=4066 Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which are likely to have a significant impact. The scope can then be expanded gradually until it becomes a mandatory part of the regulatory change control process.

Challenges in conducting RIA

Some of the major challenges in conducting RIA are:

  • Lack of Defined process: Process is extremely crucial. The lack of process can hamper the success of the process. In companies, where RIA is not adopted in the decision making process, the greatest challenge is conduct real-time regulatory monitoring and a system to track full-cycle.
  • Regulation Identification: Correct identification of the regulation and the underlying causes is essential to begin the RIA process. Further, in case of ex-post RIA, evaluation and selection of the most sub-optimal steps is crucial.
  • Regulatory Data Collection: Data collection and analysis is the most critical aspect while conducting RIA. The accuracy of the results depends on the quality of data which is often a challenging task, especially when you don’t have right tools.
  • Dealing with different types of data: Often, the data available is a mix of qualitative and quantitative data, which poses a challenge at the time of comparison as interpretation of qualitative data can differ from person to person.
  • Stakeholder and product Mapping: Another demanding task is listing all the relevant stakeholders and products who are likely to be impacted, and then accounting for all the costs and benefits (direct and indirect) for each of these, and also estimating the impact on company.
  • Dealing with biased results: Stakeholder interactions tend to be biased at times and the challenge is to limit these biases to obtain accurate data. Often another limitation is convincing stakeholders of the importance and benefits of RIA and further.
  • Ascertaining Impact: When conducting, ex-post RIA, at times an impact is caused due to various reasons and it becomes difficult to account for the contribution of a single provision/ regulation.
  • Customizing RIA: There is no one defined or established method to conduct RIA and the process is flexible. Thus, customizing the tool according to the company context and availability of data can sometimes be a formidable task.

Please suggest if a call can help to explore our RIA solution to see a fit for your environment and value ROI.

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