The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
Table of content
The Serbian regulating authority in healthcare products has published a guidance document dedicated to the processes and procedures associated with introducing changes to the existing registration entries for medical devices allowed for marketing and use in the country.
The document provides an overview of the relevant regulatory requirements and additional clarifications and recommendations to be considered by the parties involved.
The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The document titled “Instruction for Submitting a Request for Amendment/Amendment of Registration of a Medical Device” Version 11, dated 12/11/2023, issued by the Agency for Medicines and Medical Devices of Serbia, the national regulating authority in the sphere of healthcare products, provides comprehensive guidelines for entities seeking to modify the registration of medical devices in Serbia.
The document’s recommendations are vitally crucial for manufacturers and authorized representatives to understand the procedural and documentary requirements for various types of amendments to the registration of medical devices.
Overview and Submission Process
The document begins by outlining the process of submitting requests for changes or amendments to the registration of medical devices.
These submissions must be made electronically through the ePortal of the Medicines and Medical Devices Agency of Serbia.
Each request should correspond to one specific type of change or amendment.
Types of Changes and Amendments
The document categorizes the changes and amendments into three main groups:
- Amendments Requiring Changes to the Registration Decision: These include such changes as the modification of the name or address of the manufacturer’s authorized representative, change of the manufacturer’s name or address, alteration of the authorized representative, changes in the foreign manufacturer, and modification of the medical device’s name.
Each change requires specific forms and declarations, along with a stipulated tariff for each request. - Amendments Not Requiring Changes to the Registration Decision: These are changes where the agency issues a notification instead of altering the registration decision.
This category includes changes to the packaging and marking, alteration in the content of the package, modification of use/storage conditions, change of the notified or appointed body, compliance with EU regulations, and submission of updated certificates of conformity.
Similar to the first category, specific documentation and tariffs are associated with each type of request. - Changes and Additions to be Reported: This category refers to changes that do not impact the safety and performance of the medical device.
It includes modifications like graphic design changes, text layout alterations on the packaging, addition of foreign languages, and changes in labeling.
The required documents for these changes are outlined, along with the applicable tariffs.
Specific Requirements and Documentation
As further explained by the agency, each type of change or amendment has specific requirements regarding the forms to be filled, the statements and declarations needed, and the types of documents that must be submitted.
These may include a completed registration change form, manufacturer’s statements, declarations of conformity, certificates of conformity, and other relevant documents. The document meticulously details these requirements for each category and type of amendment.
Tariffs and Submission Details
The document specifies the tariffs for each type of request or solution. These tariffs are an essential part of the submission process and vary depending on the nature of the amendment or change requested.
Conclusion
In summary, the document serves as a detailed guideline for manufacturers and their authorized representatives on the procedural, documentary, and financial aspects of amending the registration of medical devices in Serbia.
It clarifies the changes that can be made, the specific documentation required, and the associated costs.
This comprehensive instruction ensures that entities involved in the production and distribution of medical devices in Serbia are well-informed and able to comply with the regulatory requirements for amendments to their product registrations.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
