Dear Audit Department:
We would like to submit a statement of case for a medical device that has expired and is in the process of applying for a new registration. The purpose of this note is to provide your department with information about our products during the period of expiration of the registration certificate and to explain why we need to apply for a new registration.
I. Reasons for the expiration of the original registration certificate
The original registration certificate of our company expired in (specific time of expiration). The main reasons for the expiration of the original registration include the following: (specific reasons, such as technology updates, changes in standards, policy adjustments, etc.). After learning that the original registration certificate expired, our company immediately began the application for a new registration certificate to ensure that the product can be re-introduced into the market in the shortest possible time.
Second, the reasons for applying for a new registration certificate
We plan to apply for a new registration certificate mainly based on the following reasons: (specific reasons, such as product upgrading or improvement, market expansion, expansion of sales channels, etc.). First of all, our products have been carried out (Detailed description of product upgrading or improvement). Second, in order to further expand our market share, we need to make a new registration application. At the same time, we realize that making new registrations will provide stricter product quality control and thus better protect public safety.
In this process, we have conducted detailed market research and technical evaluation to confirm the feasibility and necessity of applying for a new registration certificate. We understand that the process may require some key approval steps to be conducted, including clinical trials, sample testing, etc. We will continue to work closely with all parties involved in the process to ensure the safety of our products. We assure you that we will fully cooperate and accept all requirements to ensure the final issuance of the new registration certificate.
We understand that the medical device registration certificate is of great importance to public health and safety. We are committed to strictly complying with all relevant regulations and standards to ensure that our products can serve the market safely and effectively. We look forward to obtaining a new registration certificate in the near future and continue to provide high quality medical device products to the market.
We look forward to your department's approval and appreciate your support and guidance during the approval process. Please feel free to contact us if you have any questions or need further information.
Thank you!
[Company Name]
[Date]
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