PHDS HEALTHCARE RESEARCH Co., Ltd.
Key Points for Continuing Registration of Medical Devices
Release time:
2014-10-01
The "Regulations on the Registration of Medical Devices" came into effect on October 1, 2014, and re-registration has been simplified to continuation registration.
Key points for the continuation of medical device registration
The "Regulations on the Registration of Medical Devices" came into effect on October 1, 2014, and re-registration has been simplified to continuation registration. For products that have previously obtained registration certificates or products that have submitted registration applications under the old regulations, when applying for continuation registration of the registration certificate, the following points should be noted:
1. Product Category:
Class I products do not require continuation registration and can apply for filing directly, which is valid for a long time after filing. Class II and III products should apply for continuation registration after the certificate expires.
2. Product Changes:
The products for continuation registration should be completely consistent with the products that previously obtained the certificate, with no changes, including the name and address of the manufacturing enterprise, product name, model specifications, the product itself, agent, etc. If there are changes, a registration change application should be submitted.
3. Compliance Standards:
If the mandatory standards for the medical device that this product complies with have been revised, a product inspection report demonstrating that the product meets the new requirements should be provided. The product inspection report can be a self-inspection report, a commissioned inspection report, or an inspection report that complies with the implementation notice of mandatory standards. Among them, the commissioned inspection report should be issued by a medical device inspection institution with inspection qualifications.
4. Submitted Materials:
In addition to the declaration materials specified in the "Regulations on the Registration of Medical Devices", the original standard of the registered product, product technical requirements, a comparison explanation of the product technical requirements and the original registered product standard, as well as a design draft of the label for the minimum sales unit should also be provided. If there are changes in the instructions compared to the original registration, a comparison explanation of the changes and other relevant documents should be provided.
5. Application Deadline:
Before April 1, 2015, there were no deadline requirements for continuation registration. When applying for continuation registration, the original registration certificate can be within its validity period or expired (no specific deadline is currently specified). Additionally, continuation registration and registration change can be applied for together.
From April 1, 2015, it is necessary to apply for continuation registration at least 6 months before the expiration of the original registration certificate; otherwise, it should be treated as a first-time registration application. That is to say, for registration certificates expiring before October 1, 2015, the latest application date for continuation registration is March 31, 2015.
Keyword:
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