Item change procedure
Updated: July 2025, 10
If there are any changes to a medical device that has already been approved, certified, and notified, prompt procedures may be required.
In this case, the fear is that the deadline will be exceeded without you realizing it, and that you will find out after making the change that it no longer meets the requirements for permission or registration.
This is a major incident that affects the life of the company.
In order to avoid such a situation, it is necessary to accurately understand "changes that require modification procedures" and "changes that are unnecessary" and take appropriate measures.
At Support Administrative Scrivener Corporation, we have extensive experience in handling procedures associated with changing manufacturers and manufacturers of medical devices.
If you are considering any changes, please contact us.
We will explain the procedures that will be required due to the change, and then propose the optimal response for your company's case.We will thoroughly handle everything from collecting materials to actually handling the procedures, including negotiations with the applicant. We will support you.
Below, we will provide a general overview of the procedures associated with product changes.
Medical device change procedure flow and points to note
*Reference: Pharmaceutical and Medical Devices Bureau Notification No. 1120-1, November 20, 2014, "Matters to be noted when preparing an application for approval of manufacturing and sales of medical devices", Pharmaceutical and Medical Devices Bureau Notification No. 1120-4, November 20, 2014, "Matters to be noted when preparing an application for certification of manufacturing and sales of medical devices", Pharmaceutical and Medical Devices Bureau Notification No. 1121-41, November 21, 2014, "Matters to be noted when submitting a notification of manufacturing and sales of medical devices", Pharmaceutical and Medical Devices Bureau Notification No. 1023001, October 23, 2008, "Procedures for partial changes to medical devices". If a change procedure is required, the content of the procedure and points to note will vary greatly depending on the nature of the change.
About the types of procedures
The procedures are broadly classified as follows.
(Due to the complexity, this time we have excluded the classification of special treatment.)
In effect, the procedure will be finalized taking into account the impact of the change.
This makes it difficult to determine which procedures need to be taken for actual changes.
| procedure | Way of thinking | 根 拠 |
| Minor change notification (approval/certification) | (1) Addition, change, or deletion of purpose of use or effect; (ii) Changes in the method of inactivating or removing pathogenic factors; (iii) In addition to the changes listed in the preceding two items, any changes that affect the quality, efficacy, and safety of the product must be approved by the Minister of Health, Labor and Welfare under Article 23-2-5, Paragraph 11 of the Act. something that is recognized as not possible | Article 114-25 of the Enforcement Regulations of the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. (The above applies mutatis mutandis to certification (Article 118)) |
| Complete change application (approval/certification) | As a general rule, if the following changes do not affect the essence of the medical device, an application for partial change approval shall be submitted (excluding cases where a minor change notification can be submitted). (A) Minor changes in structure, raw materials, performance, etc. (b) Changes in standards, etc. regarding name, shape, dimensions, purpose of use or effect, performance and safety | 平成26年11月20日、薬食機参発1120第1号及び、平成26年11月20日、薬食機参発1120第4号 |
| Change notification (notification) | Handling in accordance with the scope of minor change notifications and complete change applications mentioned above | November 26, 11 Yakushokuki Sanbatsu 21 No. 1121 |
| New application (approval/certification/notification) | In principle, the following changes must be made through a new application for approval. (Case) ① Changes related to structure, raw materials, performance, etc., excluding those resulting from an application for approval of partial changes to approved items ② Adding a brand name | 平成26年11月20日、薬食機参発1120第1号及び、平成26年11月20日、薬食機参発1120第4号 |
| No procedures required (approval/certification/notification) | When the content of the change has no direct relationship to efficacy and safety when judged comprehensively, and does not impair the identity of the medical device in terms of its essence. | No. 20 issued by Yakushokuki, October 10, 23 |
Deadline for change procedure
Manufacturers and distributors of medical devices, within 30 days from the time of change,
It must be submitted along with the required documents to PMDA or the registered certification body that applied for certification.
However, if new application procedures are required, an application for approval or certification is required.
This is because retroactive approval or certification is not possible.
We recommend that you give sufficient consideration several months from the planning stage.
Please consult with the support administrative scrivener corporation
As mentioned above, we at Support Administrative Scrivener Corporation have extensive experience in handling procedures related to changes in manufacturers and manufacturers of medical devices, and our specialized staff quickly and reliably handles various applications for our customers. .
We also have offices in four locations across the country, in Tokyo, Nagoya, and Osaka, and can provide nationwide service from these bases.
We also accept inquiries from overseas via the Internet.
We also have staff who can speak Chinese, English, and Korean, so we can help you even if it is difficult to consult in Japanese.
Please leave the specialized and complicated procedures to us.
The first consultation is free.
