Medical device approval work menu
Updated: July 2024, 9
At Support Administrative Scrivener Corporation, one of our specialized fields is application for permits and licenses related to medical devices and operational support for business operators.
We are not just experts in creating documents. We are experts in helping businesses starting new businesses smoothly, and businesses that have already received permission to operate businesses based on legal compliance.
There are many consultants with specialized know-how in the medical device business, but we have 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.
We fully support our clients' business operations by making full use of our know-how and track record.
Please use Support Administrative Scrivener Corporation as your partner for your medical device business.
Our dedicated staff handles cases nationwide.
Support menu for manufacturers and distributors at the approval application stage and certification application stage
We provide the following support to companies preparing to obtain approval and certification for new medical devices.
・Medical device classification survey
・Strategy planning from application to approval/certification
・Face-to-face advisory support for PMDA and certification bodies
・Verification and translation of test reports at external testing institutions
・Support for creating certification application forms and attached documents (STED)
・QMS construction support
Support menu for companies in the design and development stage
We provide the following support to companies that are designing and developing new medical devices.
・Medical device classification survey
・Research and obtain information on other companies' products and similar products
・Face-to-face advisory support for PMDA and certification bodies
・Test arrangement at an external testing institute
・Support for in-house evaluation tests
・Support for creating records related to design and development
Support menu for manufacturers who already supply medical devices
For companies that are already supplying medical devices to the market, we provide the following application agency and consulting services.
・Application agency for major change applications and minor change notifications
・Support for creating and reviewing attached documents
・QMS construction consulting
・Procedure manual creation, review consulting
・Instruction manual, packaging, label creation consulting
| Category | Main menu |
| Search | Prior investigation is crucial when applying for certification or approval of medical devices. Our company provides support for the following types of investigations: ・Investigation of common names and confirmation of definition applicability ・Investigation of specified maintenance management medical devices and repair categories ・Investigation of improved classification and late development classification ・Investigation of similar products from other companies |
| Consultation support services | We will prepare materials, provide consultations, and attend consultations when face-to-face PMDA advice is provided during the medical device development and application preparation stages. ・Face-to-face advice preparation interview ・Consultation before the start of expanded medical device clinical trials ・Consultation before medical device development ・Consultation on the necessity of medical device clinical trials ・Medical device protocol consultation ・Medical device evaluation consultation ・Medical device application materials finalization consultation ・Medical device documentation sufficiency/application classification consultation ・Simple consultation for advance confirmation of medical device change notification ・Simple consultation on certification standard applicability ・General consultation |
| Evaluation test work | We arrange the following tests, which are attached to medical device certification applications and approval applications, and evaluate and translate test reports. ・Electrical safety test (JIS T 0601-1/IEC 60601-1) ・Electromagnetic safety test (JIS T 0601-1-2/IEC 60601-1-2) ・Biological safety test (JIS T0993-1/ISO 10993-1) ・Home medical device evaluation test JIS T 2001: Home phototherapy device JIS T 2002: Home massage devices and shiatsu substitute devices JIS T 2003: Home electric therapy equipment JIS T 2006: Home electromagnetic therapy device JIS T 2007: Household permanent magnet magnetic therapy device |
| Certification application/approval application support services | We support applications for certification and approval of medical devices. ・Creation of certification application form ・Creation of approval application form ・Creation of attached documents/STED ・Respond to inquiries from third-party certification bodies and PMDA |
| Change-related support services | We support work related to changes to medical devices that have obtained certification and approval. ・Application agency for partial change approval (complete change) ・Application for minor change notification ・Review of attached documents and instruction manuals ・Legal check of advertising materials |
