A medical device is a device or tool used to prevent, diagnose, and alleviate human disease or injury. Since medical devices are directly applied to the human body, their safety, effectiveness and quality controllability are very important. Therefore, the application for change of registration of medical devices is particularly important.
An application for change of registration of a medical device is usually required in the following cases:
Product principles, structures, properties, materials, specifications, etc. change.
When there is a change in the basic principle, structure, performance, materials, specifications, etc. of the product, which may affect the safety and effectiveness of the product, or cause a change in the product category, it is necessary to apply for change registration. These changes may involve changes in the hardware, software, or design of the product that require review and approval by regulatory authorities.
The production site, process, equipment, and quality standards implemented have undergone great changes.
When there is a major change in the production site, process, equipment, and quality standards of the product, it is necessary to apply for change registration. These changes may involve changes in the production process, quality control, etc., to ensure that the quality and performance of the product meet the new production conditions and standards.
There is a change in the mandatory standards or product specifications applicable to the product.
When there is a change in the mandatory standards or product specifications applicable to the product, an application for change registration is required. These changes may involve changes in the technical specifications and safety performance of the product, and it is necessary to ensure that the product meets the new mandatory standards and specifications.
The main functions and main technical indicators of the product have been changed.
When there is a change in the main functions and main technical indicators of the product, it is necessary to apply for change registration. These changes may involve changes in the way the product is used, the functional effect, etc., and it is necessary to ensure that the safety and effectiveness of the product are guaranteed.
There is a change in the scope of application or intended use of the product.
When there is a change in the scope of application or intended use of the product, it is necessary to apply for change registration. These changes may involve changes in the application field and indications of the product, and the safety and efficacy of the product need to be re-evaluated.
Changes to product inserts and labels regarding the safety and efficacy of the product.
When there is a change in the content of the product manual and label that involves the safety and effectiveness of the product, it is necessary to apply for the registration of the change. These changes may involve changes in product labeling, instructions, etc., and the labeling and description of the product need to be re-reviewed and approved.
Other changes that may affect the safety, effectiveness, and quality controllability of the product.
In addition to the above enumerated situations, there are other changes that may affect the safety, effectiveness and quality controllability of the product, such as raw materials**, production process adjustments, etc. These changes require detailed evaluation and review to ensure that the quality and performance of the product is guaranteed.
In conclusion, the application for change of registration of medical devices is very important. In any case, if the manufacturer of a medical device needs to make changes to the product, it should be applied and reported to the relevant regulatory authority in a timely manner. Through a rigorous review and approval process, the safety, efficacy, and quality controllability of medical devices can be ensured, thereby safeguarding the health and safety of the public.