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How to properly respond to US FDA regulation

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US Food and Drug Administration FDA is mainly responsible for entering the US market for the development of various types of regulatory rules, and for the regulatory rules for systematic management. Specifically, the FDA's primary task is to develop and implement rules and regulations related to the production of medical devices, including provisions related to in vitro diagnostic equipment.


From 2008 to 2014, the number of overseas inspections carried out by the FDA has more than tripled, and it is worth noting that China has become one of the high-frequency inspection areas. This trend means a huge challenge for Chinese medical device manufacturers who intend to use the United States as a global development destination. Offshore regulatory compliance has become the number of manufacturers continue to develop, to mature the number one resistance.

For those who are ambitious into the US market but the US FDA regulatory and implementation details are not familiar with the Chinese medical device manufacturers, the face of Sino-US regulatory differences exist, in line with US regulatory requirements, especially in line with the United States Food and Drug Administration (FDA) regulatory requirements are particularly important. It is also daunting to clarify the task of fine regulation of regulatory compliance between China and the United States.

In October 2015, China listed the core investment theme in the "13th Five-Year Plan", which highlighted medical devices and medical diagnosis, both of which were seen as an important economic pillar in support of the development of China's health care industry. FDA China, through its local offices and relevant departments, stressed that Chinese export enterprises not only need to comply with regulatory requirements, but also to strengthen compliance, data authenticity, product design, manufacturing, packaging, labeling, warehousing, installation and service processes Good Manufacturing Practices (GMPs) Construction. Manufacturers are actively responding to regulatory compliance as corporate responsibility, and good sense of compliance helps manufacturers build a secure global supply chain.


1. Obtain important steps for manufacturers to avoid regulatory penalties

Medical device manufacturers need to avoid the situation of quality violations, so as not to endanger its access to the US high-end medical market. In order to meet the requirements of the FDA quality system, manufacturers need to establish a standardized and systematic quality inspection process to ensure that the process detailed record for future compliance audit.

For Chinese companies that often violate FDA rules, common pitfalls appear on product design changes. Even if the product is simply changed, the surface looks insignificant, in fact, will involve important compliance matters. For example, due to vendor replacement caused by digital interface updates, manufacturing equipment updates, software upgrades, production process optimization, companies may think that only a little more to adjust the appearance of decoration only. Businesses may also ignore the material impact of changes in packaging, labeling, and processes. However, FDA requirements are more stringent, subtle changes in any product and process changes in the production process, need to be strictly controlled on the basis of a comprehensive assessment, and after the record can be applied to the product.

For enterprises to comply with FDA regulatory regulations, the rational control of such changes is very important, it is necessary to strictly integrate into the company's quality inspection system. At the same time, for the company, the management is not only bear the penalties brought about by the violation, but also in the company's products and production processes on the quality management of a major responsibility. Often, if the quality management responsibility is entrusted to the designated department head, such as the quality monitoring manager, he or she needs to report directly to the management.

Ultimately, building a healthy, comprehensive and meticulous quality management system is the most straightforward solution to avoid regulatory penalties. FDA sets out specific guidance in "Code of Federal Regulations Title 21 (21 CFR)" under Article 21 of the Federal Regulations. This generally applicable rules and regulations have been published in the Federal Register, which has fully covered the entire medical product value chain from product design to production. As an important reference for other regulators around the world, the FDA has updated its guidance on the implementation of the GMPs requirements since 2015, covering all aspects of the composite product development cycle under a single entity structure. The guidance is seen as a comprehensive innovation based on joint equipment and an important step forward in this direction. The future of systematic quality management will be a basic operational model that will guide medical device manufacturers in the complex ecosystem of continuous development and progress, in line with FDA regulatory requirements on the basis of the value chain on all aspects of management.

In general, the ideal quality management system should be from the design, raw materials, filing, equipment, facilities, processes and preventive measures and other aspects of a comprehensive control. It is important that only a management based on a reasonable regulatory basis can create a better quality management environment for the enterprise.

Details of success or failure

Medical device manufacturers have found FDA compliance guidelines to be more complex, especially when the rules are ambiguous or leave room for explanations. For enterprises, the effective measures to achieve compliance standards are the assessment of the gap, that is, to identify manufacturers compliance status and requirements of the level of compliance, as well as the gap between the industry's best practices, commonly used solutions include self-audit assessment.

FDA's simulation quality assessment allows manufacturers to compare their default benchmarks to assess their performance. Simultaneous simulation of quality assessment is also conducive to the establishment of effective compliance strategy. On this basis, the manufacturer should do a systematic review of all regulatory requirements to ensure that no requirements are missing. A common problem is that manufacturers need to ensure that the entire process can be filed in the quality system of Chinese enterprises. For example, a manager's signature, whether it is out of support for the handling of complaints, or when there is no record of proof of defects in the correction, may be the FDA quality system rules (FDA Quality System Regulation (QSR)). In this regard, the company should use a good technical architecture and IT implementation strategy to achieve automatic feedback and data analysis, and by enabling real-time correction program to ensure quality defects in real-time tracking. In some cases, when the manufacturer receives the FDA warning letter, according to the contents of the warning letter, through historical data to defend themselves.

3. Quality control and challenge when the product or production process changes: Code of Conduct

Informal communication: Avoid private verbal decisions. The application sponsor should follow the written approval process and submit the application form to the change management committee for approval.

Insufficient information: All decisions should be made in the entire process, including support for data validation and data validation, implementation plans, and effective time for change.

Insufficient training: Effective staff training is important for the FDA QSR management system. FDA may suspect that the implementation of the change when the error is caused by insufficient training.

Integrated management approach: to ensure that the quality system can be achieved from the change to initiate, review, assessment, approval, implementation to the final record of the whole process management.

What worries the manufacturers is that the FDA will always leave a divergent space when allowing them to take their own quality control. For example, manufacturers need to take responsibility for existing equipment changes to ensure that equipment can be safe and effective operation. As a result, systematic process change management is also considered a critical part of the quality management system. Specifically, medical device equipment management design process, the need for the entire development cycle of all the design changes to review to ensure that all changes meet the management requirements.


In fact, the potential risk of medical device manufacturers that may violate the FDA's quality system is fourfold:

First, the US FDA 21 CFR820.30 (a) clearly stipulates that if the manufacturer lacks the monitoring program design and the written record, it can not prove that they have the program design monitoring ability and have the corresponding written record.

Second, lack of corrective agreement and precautionary measures. According to the US FDA 21 CFR820.100 (a), the company only provides the correct form of corrective action and precautionary measures (CAPA), and does not actually refer to any programmed training related to corrective action and precautionary measures, nor does it begin to use CAPA system.

Thirdly, according to FDA 21 CFR820.20 (a), management has failed to ensure that quality management is institutionalized and lacks sound, documented, operational quality management regulations and work objectives.

Finally, pursuant to US FDA 21 CFR 820.20 (c), the enterprise has not established a review mechanism that meets the management review criteria. Ultimately, ignoring any of the above mentioned points or all of the above mentioned quality control measures are likely to have a profound impact on the business.

Historically, the medical device industry has a huge profit margins, especially in the United States and most parts of the world today, the trend of aging society, the industry can withstand the risks of economic downturn. By assisting medical device manufacturers in accelerating capitalization in the market, FDA compliance experts and consultants will be guided by manufacturers to comply with regulatory requirements for FDA QSR and ISO FDIS 13485.
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