ISO 13485 و21 CFR 820: ما يحتاج مصنعو الأجهزة الطبية إلى معرفته 

The U.S. Food and Drug Administration (FDA) has introduced a significant amendment to 21 CFR 820, which regulates the Quality System Regulation (QSR) for medical device manufacturers. The update incorporates by reference the ISO 13485:2016 standard, an internationally recognised framework for quality management systems (QMS) specific to medical devices. This alignment is a critical development, reflecting the FDA’s efforts to harmonise U.S. regulations with global standards, thereby simplifying compliance for manufacturers operating in multiple markets.

في هذه المقالة، سنستكشف الاختلافات في عملية التقديم، وما الجديد لمصنّعي الأجهزة الطبية، و كيف يمكن للشركات التنقل خلال هذا التحول بفعالية.

ISO 13485:2016 مقابل 21 CFR 820

21 CFR 820 has long been the cornerstone of quality management for medical devices in the U.S., setting the requirements for quality systems that manufacturers must establish and maintain. ISO 13485:2016, on the other hand, is a globally recognised standard that outlines the criteria for a QMS, focusing specifically on medical devices. While both frameworks share the common goal of ensuring product quality and patient safety, ISO 13485:2016 is more detailed in certain areas and has a broader international scope.

By incorporating ISO 13485:2016 into 21 CFR 820, the FDA aims to streamline regulatory compliance for medical device manufacturers who sell products both in the U.S. and internationally. This amendment reduces the burden of maintaining separate QMSs for different markets and encourages the adoption of best practices globally.

التغييرات الرئيسية في عملية التقديم

مع دمج ISO 13485:2016 في 21 CFR 820، ستشهد عملية تقديم طلبات مصنّعي الأجهزة الطبية عدة تغييرات:

متطلبات التوثيق

• توثيق نظام إدارة الجودة الموحد: Manufacturers can now leverage a unified QMS documentation that meets both FDA and international requirements. This means that the same set of documents used to comply with ISO 13485:2016 can be submitted to the FDA, simplifying the process and reducing duplication.
• وثائق إدارة المخاطر: ISO 13485:2016 places a strong emphasis on risk management throughout the product lifecycle. Manufacturers must ensure that risk management activities are thoroughly documented and integrated into their QMS. This documentation will now be a critical component of the submission process to the FDA.

الجاهزية للتدقيق والتفتيش

• نهج التدقيق المنسق: The alignment of 21 CFR 820 and ISO 13485:2016 may lead to a more harmonised audit approach. Manufacturers should be prepared for FDA inspections that closely resemble those conducted by international bodies under ISO 13485. This includes being ready to demonstrate how their QMS complies with both sets of requirements during inspections.
• ضوابط الموردين: ISO 13485:2016 places greater emphasis on supplier controls and the verification of purchased products. Manufacturers will need to provide detailed documentation on supplier selection, evaluation, and monitoring processes, which will be scrutinised during FDA audits.

نهج قائم على المخاطر

• تركيز معزز على إدارة المخاطر: The risk-based approach central to ISO 13485:2016 is now explicitly incorporated into the U.S. regulatory framework. Manufacturers must ensure that their risk management processes are robust and fully integrated into their QMS. This includes demonstrating how risks are identified, evaluated, and mitigated at every stage of the product lifecycle.

هل تحتاج إلى دعم تنظيمي؟ اطّلع على ما يمكننا تقديمه لك

اعرف المزيد

اعرف المزيد

ما الجديد لمصنّعي الأجهزة الطبية؟

يقدم تعديل 21 CFR 820 عدة متطلبات واعتبارات جديدة لمصنعي الأجهزة الطبية:

التنسيق العالمي

• الامتثال المبسّط: For manufacturers operating globally, the incorporation of ISO 13485:2016 into U.S. regulations simplifies compliance efforts. A single QMS can now be developed and maintained to meet both FDA and international standards, reducing administrative burdens and potential compliance risks.
• زيادة الوصول إلى السوق: سيجد المصنّعون الحاصلون على شهادة ISO 13485:2016 سهولة أكبر في دخول السوق الأمريكية، حيث يمكن تكييف نظام إدارة الجودة الحالي لديهم بسهولة أكبر لتلبية متطلبات إدارة الغذاء والدواء (FDA).

زيادة الرقابة التنظيمية

• تطبيق أكثر صرامة لإدارة المخاطر: The FDA’s adoption of ISO 13485:2016 means that risk management is now more central to regulatory compliance. Manufacturers can expect increased scrutiny of their risk management processes during FDA inspections, with a particular focus on how risks are managed and mitigated throughout the product lifecycle.
• التركيز على مراقبة ما بعد التسويق: ISO 13485:2016 requires manufacturers to implement robust post-market surveillance systems. The FDA will likely place greater emphasis on these activities during inspections, requiring manufacturers to demonstrate how they monitor and respond to product performance in the field.

فترة الانتقال والمواعيد النهائية للامتثال

• تخطيط الانتقال: Manufacturers currently compliant with 21 CFR 820 but not yet fully aligned with ISO 13485:2016 will need to plan for a smooth transition. The FDA is expected to provide a transition period, during which manufacturers can update their QMS and ensure compliance with the new requirements.
• التدريب والتعليم: Companies will need to invest in training for their teams to understand the nuances of ISO 13485:2016 and how it differs from the previous 21 CFR 820 requirements. This is essential to ensure that all staff involved in the QMS, from top management to operational personnel, are fully aware of their roles in maintaining compliance.

الاستعداد للمستقبل: استراتيجيات الامتثال

للتعامل مع التغييرات التي أدخلها تعديل 21 CFR 820، ينبغي لمصنعي الأجهزة الطبية النظر في الاستراتيجيات التالية:

إجراء تحليل الفجوات

• تحديد مجالات التحسين: Manufacturers should conduct a thorough gap analysis to identify areas where their current QMS falls short of the ISO 13485:2016 requirements. This analysis will help prioritize updates and ensure that the transition is as smooth as possible.

تحديث الوثائق والعمليات

• مراجعة وثائق نظام إدارة الجودة (QMS): يجب على المصنّعين تحديث وثائق نظام إدارة الجودة (QMS) الخاصة بهم لتتوافق مع ISO 13485:2016. ويشمل ذلك مراجعة الإجراءات وتعليمات العمل والنماذج لتعكس المتطلبات الجديدة.
• تعزيز إدارة الموردين: Given the increased emphasis on supplier controls, manufacturers should review and enhance their supplier management processes. This may involve more rigorous supplier evaluations, increased oversight, and more detailed documentation.

الاستثمار في التدريب والتعليم

• درّب فريقك: Ensuring that all employees understand the new requirements is critical to maintaining compliance. Manufacturers should invest in comprehensive training programs that cover the key changes and how they impact day-to-day operations.

مراقبة التطورات التنظيمية

• ابقَ على اطلاع: The regulatory landscape is constantly evolving. Manufacturers should stay informed about ongoing developments related to 21 CFR 820 and ISO 13485:2016 to ensure they remain compliant with the latest requirements.

تأكد من جاهزية شركتك للوائح FDA الجديدة

The amendment to 21 CFR 820 marks a significant shift in the regulatory landscape for medical device manufacturers in the U.S. By incorporating ISO 13485:2016, the FDA has taken a major step toward global harmonisation of quality management systems. While this change brings new challenges, it also offers opportunities for manufacturers to streamline their compliance efforts and enhance their global market presence. By understanding the key differences in the submission process and preparing for the new requirements, manufacturers can ensure a smooth transition and continue to deliver safe and effective الأجهزة الطبية للمرضى حول العالم.

هل تحتاج إلى إرشاد للتنقل في ISO 13485؟ سيساعدك خبراؤنا على ضمان جاهزية شركتك للوائح FDA الجديدة. تواصل معنا اليوم.

الأسئلة الشائعة: ISO 13485 و21 CFR 820