Medical equipment available for use
Updated: July 2024, 3
We provide medical equipment, medical equipment, and other support services.
We have been working for a long time to create articles in this category, but we also support the development of new business operations, and support the business operations of our customers.
Unfortunately, there is a lack of knowledge in the medical equipment industry, but we are not responsible for the production, enterprise, and administrative machinery operations of each department. Learn about the excellence and excellence of the industry.
Our general staff will make full use of our practical work, and our customers will provide comprehensive support for their work.
Ideas for expanding the medical equipment industry or those working in the medical equipment industry are unnecessary.
Our new business operations and new business ventures provide the following business support:
- Check the compatibility of medical equipment
- Manufacturer's license application
- Medical equipment ratification application, certification application, manufacturing defect report
- QMS system construction guide
- Internal system construction guideline
Our vision is to provide overseas medical equipment manufacturers in the Japanese market and support the following businesses:
- Check the compatibility of medical equipment
- Agent, co-worker
- Application for registration of foreign manufacturing business
- Representative manufacturer's license application
- Medical equipment approval application, approval application, manufacturing equipment report application
- QMS system construction guide
Our company provides the following business support:
- Renewal of permission and application of permission
- New product approval, certification, declaration of approval
- Request for medical equipment entry/exit points
- QMS system construction guide
- Quality management procedure manual production guide
- STED production book
- Operation instructions, packaging, and labeling instructions
- Internal planning support
Application and application fee list
Medical equipment manufacturing license
| Project | Message |
| Medical equipment manufacturing purchase order | 1st, 2nd, and 3rd category medical equipment manufacturing industry is permitted. Attendance attendance record |
| Application for renewal of medical equipment manufacturing | 5th year medical equipment manufacturing sales record renewal Attendance attendance record |
| Medical equipment manufacturing change | 针对medical equipment manufacturing business is allowed, employees and others change, agency change change plan table: ・Applicant's residence, name (under corporate circumstances, location or name of office), name of office, etc. ・Changed main office location ・Business staff ・Person responsible for manufacturing the product ・Family name or place of residence of the person responsible for manufacturing the product |
Medical equipment manufacturing industry specialist
| Project | Message |
| Medical equipment manufacturing industry order approval | Medical equipment manufacturing center for all prefectures across the world Attendance attendance record |
| Application for renewal of medical equipment manufacturing industry | 5th year medical equipment manufacturing sales renewal Attendance attendance record |
| Medical equipment manufacturing business change | Qingqi Medical Equipment Manufacturing Sales Notes, Changes to Employees and Other Changes, and Changes to the Agency: ・Applicant's residence, name (under corporate circumstances, location or name of office), name of office, etc. ・Changed main office location ・Business staff ・Technical manager ・Technical manager's name and place of residence |
Medical equipment repair industry license
| Project | Message |
| Medical equipment repair license | Medical equipment repair service available for prefectures across the world Attendance attendance record |
| Addition of medical equipment repair category/Change permission request | Addition/change of medical equipment repair category to agency report |
| Medical equipment repair permit renewal application | Licensed renewal of medical equipment repair every 5 years Attendance attendance record |
| Medical equipment repair business permit change | Qianqi medical equipment repair business is allowed, staff and other personnel change time, agency change change support table: ・Applicant's residence, name (under corporate circumstances, location or name of office), name of office, etc. ・Construction equipment ・Business staff ・Technical manager ・Technical manager's name and place of residence ・Repair-specific suspension |
Medical equipment sales department
| Project | Message |
| Highly managed medical equipment sales/concession industry | Highly managed medical equipment sales/concession available for prefectures across the country Attendance attendance record |
| Management medical equipment sales business/concession business planning book | Agency application management medical business business/concession business planning book. |
Manual for each category of medical equipment
| Project | Message |
| Application for approval of medical equipment manufacturing Application for approval of partial changes in medical equipment manufacturing business Application for ratification of foreign-manufactured medical equipment manufacturing Application for ratification of foreign-manufactured medical equipment Medical equipment manufacturing bill ratification matter minor changes modification plan book Foreign-manufactured medical equipment manufacturing defect review matter minor changes modification plan book Medical equipment/in vitro diagnostic medical equipment Compatibility test report (QMS test) Foreign-manufactured medical equipment/in vitro diagnostic medical equipment Compatibility test report (QMS test) Outlet Medical Equipment Compatibility Test Report Book (QMS Track) Medical equipment manufacturing plan Foreign-manufactured medical equipment/in vitro diagnostic medical equipment manufacturing booklet Exit medical equipment manufacturing, etc./Exit equipment plan book Selected Foreign Manufactured Medical Equipment Manufacturer/Foreign Manufactured Medical Equipment, etc. Special Approval Holder Change Plan | Application for ratification of third and fourth categories of medical equipment |
| Designated highly managed medical equipment manufacturing certification certification Designated managed medical equipment manufacturing certification certification Designated highly controlled medical equipment, etc. compatibility test report Approval of manufacturing of designated highly controlled medical equipment Designated managed medical equipment manufacturing purchase certification part change certification certification booklet Designated highly managed medical equipment certification matter minor changes modification plan book Designated managed medical equipment certification matter minor change modification plan book | 针对 the second category of medical equipment, the third category of certified medical equipment, the certification of the machine for the generation. |
| Medical equipment manufacturing booklet Medical equipment manufacturing business submission matter change modification plan book | Qianqi 1st category medical equipment, submitted to Daiyo PMDA |
QMS system construction study guide
| Project | Message |
| QSM quality management procedure established | New application time, combined company information, established QSM quality management procedure procedure |
| QSM Quality Management Procedure Procedure Repair | During the current QSM quality management process, the implementation process is complete and complete. Legal inspection, repair QSM quality management procedure manual |
| Regular letter production support | 3-month 1st class performance rate, confirmation of periodical writing and correspondence records, cooperation QMS maintenance and proper operation |
| Internal accounting support | After completion of the production, the internal calculations will be carried out, and the results will be reported and the results will be reported. |
| Supporting education and learning | Providing educational and cultural planning for the year, providing support for planning, supporting and maintaining educational and cultural development. |
