Medical device manufacturers often face critical challenges for delayed submission for regulatory approval. The late submission often results in delayed entry of the product into the market. Medical device regulatory consulting services like Maven identify the common reasons for delayed approval or getting the application rejected by agencies like the FDA, EMA, or other governing authorities. Most of the applications face rejection due to the common errors, misunderstandings, and omissions as specified by the regulatory requirements. This setback not only takes longer but also puts the unnecessary burden of excess cost on the manufacturers.
Common causes for delayed submission
With the presence of multiple markets and regulatory environments, medical device manufacturers face significant challenges, and they need to take strategic decisions for complying with the regulatory requirements of the governing authority.
- Incomplete data
Medical device manufacturers often submit inaccurate data without any comprehensive assessment details of the product’s safety and efficacy and face challenges of unwanted delay in approval. Regulatory bodies reject such applications that have inconsistent clinical trial result data, poor presentation of data, and data without any supportive evidence.
- Incomplete technical documentation
Regulatory reviewers check the clear and concise documentation for assessing the safety and performance after application on the human body. Disorganized documents face higher chances of getting rejected. For example, there is a specific technical documentation format to follow for compliance, like ISO 14971-compliant DHF for FDA (US).
- Non-compliance with regulatory guidelines
Insufficient understanding of regulatory guidelines leads to non-compliance with the guidelines and creates unnecessary delay. A region-specific gap analysis for submission is mandatory for supporting the current existing regulation or industry guidelines.
- Inadequate risk management
Any submission that does not have a proper risk management plan gets rejected. The effective plans for post-market surveillance lead to delays in the approval process. The regulatory body wants to see the details of risk probability, mitigation, and monitoring strategy crucial for human life safety.
Medical device regulatory consulting for delayed submission
- Medical devices Regulatory consulting services offer a detailed understanding of regulatory intelligence. It performs the systematic collection of data and provides the relevant information regarding the new policy or enforcement for marketing the medical device that leads to avoiding unnecessary hazards of late submission.
- The professional medical devices regulatory consulting services use the automation and software tools to scan the regulatory intelligence guidelines and policy database and ensure all the requirements are fulfilled according to the updated announcement.
- • A medical device regulatory consultant helps you in risk categorization as “high risk” or “low risk” of medical devices or IVDs and labels them to get attention according to the priority.
Moreover, the tailored documentation support, guidance over regulatory compliance, and post-market surveillance from medical device regulatory consulting services ensure patient safety and timely reporting to regulatory authorities.
Engaging with professional consultation for gap analysis is pivotal for avoiding setbacks and timely submission of documents with proper format. Prepare an effective strategy for compliance and mitigate risk with the expert consultation, and avoid late submission that not only makes the delay in market product but also costs more.
