Approval of highly controlled medical devices
Updated: July 2024, 9
At Support Administrative Scrivener Corporation, we support those who are thinking of distributing highly controlled medical devices that fall under Class II, III, or IV to the market.
For medical device approval, we provide consistent support from investigation to compliance testing, application/STED creation, and application agency.
Business menu for approval application for highly controlled medical devices
| Application/consulting menu | Message |
| Search | Investigate the classification, common name, and approval criteria of the medical device for which you plan to apply for approval. Obtain information on similar products and identify the process up to approval application. Regarding the application method, we will also consider improved medical devices, generic medical devices, and the presence or absence of clinical trials. |
| Face-to-face advice support service | In many cases, when applying for approval, face-to-face advice from the PMDA is used. We prepare materials and attend consultations for face-to-face advice, including face-to-face advice preparation interviews, consultations before the start of expanded clinical trials, pre-development consultations, consultations to finalize application documents, consultations on the necessity of clinical trials, protocol consultations, consultations on document sufficiency and application classification, consultations on reliability standard compliance surveys, consultations on usage results evaluation compliance surveys, and evaluation consultations. |
| Evaluation test implementation support service | We support and arrange the following test implementation for the evaluation test report attached to STED. electrical safety test Electromagnetic safety test Biological safety testing PSE exam Technical Conformity Mark (Technical Standards Conformity Certification) |
| Approval application/STEAD creation support service | We will create the approval application form and attached documents (STEAD). We translate reports of evaluation tests conducted overseas and create instruction manuals, labels, etc. |
| Application agency/inquiry handling | We will act on your behalf to apply to PMDA and then respond to inquiries that continue multiple times. |
Medical device approval application process
| Step 1 | Investigation of medical device suitability/application category | We investigate which general name and class classification the medical device you are considering falls under, and if applicable, whether there are any approval standards. |
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| Step 2 | Policy formulation | Develop a roadmap for obtaining medical device approval. Is it possible to proceed with the application using the materials that you currently have? Is a new evaluation test necessary? Do you need face-to-face advice from PMDA? We will discuss the policy leading up to obtaining approval and proceed with the formulation of a process chart. |
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| Step 3 | Conducting conformance tests to JIS industrial standards and ISO standards | In cases where in-house testing is difficult or foreign test reports are not available in Japan, we request a domestic inspection agency to perform the test and conduct a JIS industrial standard compliance test. If each item is met, an inspection report will be issued. |
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| Step 4 | Medical device approval application form Application form creation | We will create an application form to apply for medical device approval. The application form is roughly divided into two parts: the approval application form and the application document attachments called STED. STED includes inspection reports that comply with JIS industrial standards, so it is quite large. |
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| Step 5 | Medical device approval application submission | Apply to PMDA. |
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| Step 6 | QMS conformity survey | A QMS compliance survey is conducted during the approval application review process. If this is your first case, the investigation will take a total of three days. Preparation should focus on design and development. |
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| Step 7 | Medical device approval certificate issued | A medical device approval number will be issued and manufacturing and sales of medical devices can begin. |
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.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
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.
