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المملكة: In 3 phases .. new controls for registering integrated medical products
I put off The Food and Drug General Authority draft “The Classification and Registration of Overly Completed Products Directory”, which sets a clear framework for dealing with this complex category of products. Complete. Organizational Challenge
Back to top button Organizational Challenge
This evidence comes, in response to the urgent need for the existence of an organizational framework that dismantles the intertwining that accompanies modern products that combine the properties of The medicine and the medical system, or between different regulatory categories. The highest safety, quality and effective standards before reaching the patient. The main work mechanism
The Authority has identified a basic officer to resolve the classification of any overlapping product, which is the “Principal Mode of Action”. Under this scientific principle, the technical sector responsible for evaluating the product is determined based on the basic way in which its medical purpose is achieved. If these means are secondary and assistance, the product will undergo control and registration of the “medical devices” sector. This principle provides a solid basis to ensure that each product is evaluated by the most knowledgeable experts and its potential benefits." target ="_Blank"> Registration requests initial and fulfill the basic requirements of the responsible sector that was identified. Transitional period
The second stage comes between 2027 and 2028, to be a transitional period that gives applicants the option of submitting the full registration file for the basic product, with the attachment of the requirements for the auxiliary component. The components of the “basic and secondary” product in accordance with the highest approved standards, to ensure the existence of a complete and comprehensive image of the product with the authority. /> After obtaining the official classification, the company moves to the registration stage with the competent sector, where the review periods differ according to the nature of the product, which provides an organized and transparent path that serves all parties. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
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This evidence comes, in response to the urgent need for the existence of an organizational framework that dismantles the intertwining that accompanies modern products that combine the properties of The medicine and the medical system, or between different regulatory categories. The highest safety, quality and effective standards before reaching the patient.
The main work mechanism
The Authority has identified a basic officer to resolve the classification of any overlapping product, which is the “Principal Mode of Action”. Under this scientific principle, the technical sector responsible for evaluating the product is determined based on the basic way in which its medical purpose is achieved. If these means are secondary and assistance, the product will undergo control and registration of the “medical devices” sector. This principle provides a solid basis to ensure that each product is evaluated by the most knowledgeable experts and its potential benefits." target ="_Blank"> Registration requests initial and fulfill the basic requirements of the responsible sector that was identified. Transitional period
The second stage comes between 2027 and 2028, to be a transitional period that gives applicants the option of submitting the full registration file for the basic product, with the attachment of the requirements for the auxiliary component. The components of the “basic and secondary” product in accordance with the highest approved standards, to ensure the existence of a complete and comprehensive image of the product with the authority. /> After obtaining the official classification, the company moves to the registration stage with the competent sector, where the review periods differ according to the nature of the product, which provides an organized and transparent path that serves all parties. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
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The Authority has identified a basic officer to resolve the classification of any overlapping product, which is the “Principal Mode of Action”. Under this scientific principle, the technical sector responsible for evaluating the product is determined based on the basic way in which its medical purpose is achieved. If these means are secondary and assistance, the product will undergo control and registration of the “medical devices” sector. This principle provides a solid basis to ensure that each product is evaluated by the most knowledgeable experts and its potential benefits." target ="_Blank"> Registration requests initial and fulfill the basic requirements of the responsible sector that was identified.
Transitional period
The second stage comes between 2027 and 2028, to be a transitional period that gives applicants the option of submitting the full registration file for the basic product, with the attachment of the requirements for the auxiliary component. The components of the “basic and secondary” product in accordance with the highest approved standards, to ensure the existence of a complete and comprehensive image of the product with the authority. /> After obtaining the official classification, the company moves to the registration stage with the competent sector, where the review periods differ according to the nature of the product, which provides an organized and transparent path that serves all parties. - For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
Follow Us Related Articles
The second stage comes between 2027 and 2028, to be a transitional period that gives applicants the option of submitting the full registration file for the basic product, with the attachment of the requirements for the auxiliary component. The components of the “basic and secondary” product in accordance with the highest approved standards, to ensure the existence of a complete and comprehensive image of the product with the authority. /> After obtaining the official classification, the company moves to the registration stage with the competent sector, where the review periods differ according to the nature of the product, which provides an organized and transparent path that serves all parties.
- For more: Follow Khaleejion 24 Arabic, Khaleejion 24 English, Khaleejion 24 Live, and for social media follow us on Facebook and Twitter
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