Tartalomjegyzék

Egészség Kanada, az egészségügyi termékekkel foglalkozó kanadai szabályozó hatóság, útmutatást tett közzé az orvostechnikai eszközökre vonatkozó engedélykérelmek kezelésével kapcsolatban.

A dokumentum áttekintést ad az alkalmazandó szabályozási követelményekről, valamint további magyarázatokat és ajánlásokat tartalmaz, amelyeket az orvostechnikai eszközök gyártóinak és más érintett feleknek figyelembe kell venniük az ezeknek való megfelelés biztosítása érdekében.

Ugyanakkor az útmutató rendelkezései jogi természetüknél fogva nem kötelező erejűek, nem célja új szabályok bevezetése vagy új kötelezettségek előírása.

Moreover, the authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect the corresponding amendments to the underlying legislation.

Szabályozási háttér

In particular, the present document outlines the approach to managing applications for medical device licenses.
It emphasizes the importance of facilitating compliance with Medical Devices Regulations to safeguard public health.

This guidance provides important recommendations to be considered by entities dealing with Class II, III, and IV medical devices, covering various application scenarios, including amendments and private-label applications.

It emphasizes the importance of pre-submission consultations with the Medical Devices Directorate, offering a pathway for tailored guidance.

The document describes in detail the existing procedures for application management that Health Canada follows. It is designed to navigate the complexities of regulatory compliance, ensuring that the medical device market is furnished with safe and effective products.

According to the guidance, the uniform application of management principles is a cornerstone of the existing regulatory approach.

It ensures that all applications undergo thorough scrutiny for completeness and that the data submitted supporting an application is under Health Canada’s management.

The document outlines the key points related to the application submission and review process.

Filing Applications

First, the document describes the relevant procedural specifics for submitting applications and amendments, including contact information and submission addresses.
This section acts as a practical guide for manufacturers commencing the application process.

Tools and Documents

The present document issued by Health Canada provides references to multiple resources, including guidelines and application forms, to streamline the application process.
This section highlights the availability of these resources, encouraging their use to ensure compliance and facilitate successful submissions.

Administrative Screening

According to the guidance, the initial application review phase focuses on administrative completeness.
This process is characterized by a swift turnaround time, aiming to expedite the screening process.

Notifications of acceptance or requests for additional information are part of this procedural step, ensuring clarity and efficiency in application processing.

Regulatory Screening

As further explained by the authority, following administrative review, applications are scrutinized for regulatory compliance.
This involves a comprehensive review of the device classification, quality management certifications, and other regulatory prerequisites.

The outcomes of this screening can significantly impact the application’s progression, with detailed feedback provided to address any deficiencies.

Technical Screening

Critical for Class III and IV device applications, this screening ensures the submission encompasses all necessary scientific evidence supporting the device’s safety and effectiveness.
This stage is pivotal in the application process, with a structured response mechanism for addressing any identified deficiencies.

Fee Status

The document also outlines the fee structure associated with application processing. Importantly, it specifies the conditions under which fees are to be paid, offering clarity on the financial aspects of application submission and review.

This includes detailed information on fees for different types of applications and the implications of application acceptance or rejection on fee assessments.

Resubmission and Appeals

The guidance outlines a clear pathway for resubmission for applications that face rejection, emphasizing the necessity of a comprehensive and compliant new application. Additionally, it provides a procedural outline for appealing decisions, offering manufacturers a recourse to contest unfavorable outcomes.

Következtetés

In summary, the present Health Canada guidance document on managing applications for medical device licenses describes the application process to be followed when placing new products on the market, ensuring that medical devices entering the market meet the highest safety and efficacy standards.
The guidance aims to provide medical device manufacturers and other parties involved with additional information related to the submission and processing of applications.

forrás

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html

Hogyan segíthet a RegDesk?

A RegDesk egy holisztikus szabályozási információkezelő rendszer, amely az orvostechnikai eszközöket és a gyógyszeripari vállalatokat szabályozó intelligenciával látja el a világ több mint 120 piacán. Segíthet globális alkalmazások előkészítésében és közzétételében, szabványok kezelésében, változásértékelések futtatásában, valamint valós idejű riasztások beszerzésében a szabályozási változásokról egy központi platformon keresztül. Ügyfeleink hozzáférhetnek világszerte több mint 4000 megfelelőségi szakértőből álló hálózatunkhoz, hogy ellenőrzést kapjanak a kritikus kérdésekben. A globális terjeszkedés még soha nem volt ilyen egyszerű.