Notification of minor changes in approval/certification
Updated: July 2024, 9
Support Administrative Scrivener Corporation provides support for minor change notifications for products that have received medical device manufacturing and sales approval and medical device manufacturing and sales certification.
We will support those who are completing the procedure for the first time, or those who find it difficult to handle it in-house, with our resources and know-how.
If you are having trouble with notification of minor changes to medical device manufacturing and sales approval or medical device manufacturing and sales certification, please feel free to contact us.
Cases where notification of minor changes in approval/certification is required
According to the Pharmaceutical Biomedical Devices Review No. 29 No. 7 of July 31, 0731, “Handling of minor change procedures, etc. associated with partial changes to medical devices,” partial change approval (complete change) is required in the following cases: It has been.
| ① | Changes that increase existing risks or create new risks regarding product quality, efficacy, or safety, and the impact on human life and health cannot be said to be clearly minor. |
| ② | Changes in which the impact on the quality, efficacy, and safety of the product cannot be fully estimated, and the impact on human life and health cannot be said to be clearly minor. |
| ③ | Changes in the shape or structure of a product that do not clearly result in loss of product identity (small-scale changes that, if repeated, will result in loss of product identity; changes that result in significant changes in shape) (Changes that make it difficult to identify the product, changes that substantially change the method of use, etc. due to significant structural changes.) |
| 4 | In addition to those who fall under ① to ③, those who violate laws and regulations related to pharmaceutical affairs such as the Pharmaceutical and Medical Device Act, the Narcotic Drugs and Psychotropic Substances Control Act, and the Poisonous and Deleterious Substances Control Act, or any disposition based thereon. A person for whom two years have not passed since the date of the violation. |
| ⑤ | Adult wards or addicts to narcotics, cannabis, opium or stimulants |
| ⑥ | A person specified by Ordinance of the Ministry of Health, Labor and Welfare as a person who is unable to properly sell or lend highly controlled medical devices or specified maintenance controlled medical devices due to physical or mental disabilities. |
Any changes other than those mentioned above will be subject to a minor change notification.
Examples of items that are subject to minor change notifications are given in the same notification.
Regarding the scope of minor change notifications
1. Shape, structure and principle column
| ① | Changes in names, etc. of components that do not involve changes in structure, function, etc. |
| ② | Changes in the names, etc. of medical devices, etc. used together |
| ③ | Changes in the dimensions, size, etc. of each part of the product that have an obviously minor impact on the quality, efficacy, and safety of the product |
| 4 | A change in which a concomitant medical device with another already approved (certified, notified) item with the same purpose and method of use is added as a concomitant medical device, or a change in an already prescribed concomitant medical device to the relevant concomitant medical device. . However, if all of the following (1) to (4) are met. (1) The purpose of use is equivalent to that of the current concomitant medical device. (2) There is no change in the purpose or method of use of the product as a whole. (3) The general name of the current concomitant medical device and the additional concomitant medical device shall be the same. (4) For items to be used in combination, there is a precedent for evaluation of combinations, and no new evaluation is required. |
| ⑤ | Elimination of variations in components, accessories, or concomitant medical devices that have an obviously minor impact on product quality, efficacy, and safety. |
| ⑥ | Other Information |
2. Standards column regarding performance and safety
| ① | When a comparative test with an existing product is set up, a change in the description of the medical device for which the comparative test is set up without substantial change |
| ② | Changes in product specifications that have an obviously minor impact on product quality, efficacy, and safety |
XNUMX. XNUMX.others
| ① | Change of measurement unit without change in approval (certification) matters |
Regarding the range that requires confirmation through a simple preliminary consultation on an individual basis
Shape, structure and principle column
| ① | Changes in the dimensions of various parts that may clearly have a more than minor impact on the quality, efficacy, and safety of the product. |
| ② | Shape changes and additions to the range of similar products in orthopedic implant products |
| ③ | Changes in functions, usage modes, etc. that may clearly have a more than minor impact on product quality, efficacy, and safety. |
| 4 | Other Information |
Standards column regarding performance and safety
| ① | Additions or changes to functions that may clearly have a more than minor impact on product quality, efficacy, and safety |
| ② | Changes in test conditions, etc. of standard tests, deletion of descriptions, etc. |
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
