Chinese medical equipment advancement Japan
Updated: July 2024, 3
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table of contents
1. Are you in trouble?
The demands of Chinese manufacturing commerce (foreign manufacturing commerce) and medical equipment manufacturing commerce (medical equipment manufacturing merchandising) are closely combined, and there is an unskilled administration and certification machinery, and the costs and costs are high.
Support Administrative Scrivener Corporation
为您provided by commercial medical equipment outlet Japanese service
2. Main duties
Quality control report
Applicability of certification, search for similar products, specific process, time, completeness, etc. in advance.
Interaction with the residence
Intervening in Chinese manufacturing and commerce, intervening in the international trade, administrative and certification machinery, establishing a third-party neutral position, promoting high-efficiency communication and exchange.
Production of each category of materials (comprehensive quality management procedure procedure) approval
Support for the production of application documents, supplementary materials (STED), QMS compatibility research, quality management procedure manuals and their record catalogues.
Agency handling application procedure, direct application completion, whole process management
Quality control procedure training and field training
Pre-preparation scene test, analysis quality management procedure procedure, how to use the complete product production field test
Current monitoring support and improvement report
Comprehensive current situation monitoring, current situation support, support in urgent situations, immediate improvement report after incomplete local start-up, full support.
Item management and content management
Provide complete certification time management and item management services, complete product certification application within fixed time.
3. Reason for selection support administrative scrivener corporation
The most convenient way to ensure the fastest speed is to ensure that you can purchase the most valuable items for your family's staff.
[Regular question]
- Lawless correctness, high efficiency and direct connection, input time and human power are huge
- Unknown way to solve the problem, since time has passed, the problem is always stagnate.
- Each item has been revised and adjusted, and the waste time has been adjusted accordingly.
▼Support provided by administrative scrivener corporation
A clear explanation process, you can choose the time and schedule the recommended progress items.
Providing the entire process of Chinese language communication, breaking the language barrier
[Regular question]
- Uncommunicative language, non-university, illegal communication.
- No legal provisions were established and the items were stagnant.
- The work style and business customs of the unskilled people, the promotion of business operations.
▼Support provided by administrative scrivener corporation
- Based on the objectives and progress of the development process, the actual work will be carried out directly and effectively, and the completion process will be completed in each category.
- We are promoting the promotion of third-party neutrality and the exclusion of unimpressed commercial products from Japanese tourists.
4. Commission for your honor
[1] The Japanese problem of one-stop solution and customer service
Please confirm the details of the machine and arrange the exchange.
Preparation for assistance in proceeding with on-site training, joint on-site monitoring, repair and improvement reports, etc. will be waived after the event.
▶Do not discontinue the certification process itself, the entire process will be explained, and the questions in the process will be explained.
[2] Medical equipment certification and support from commercial organizations
Tokyo (Shinjuku, Akihabara), Nagoya, Osaka uniform design public locations.
Combined product characteristics and item special features, pre-preparation for land development, order development.
▶Approximately large amount of time to complete the book, purchase order, income, demand and product confirmation
[3] A complete copy of the original language due to the elimination of language.
Provided by the Chinese and Japanese Japanese language contact service.
If you directly agree to the terms, you can go through the process and write down the rules.
▶Unable to speak words, to the maximum extent possible to eliminate language communication difficulties.
5. Past business (part)
✓ Company A (household electric appliance trading company/electronic manufacturer)
[Project] China's massage machine exit to Japan (product number 1 of the top ten massage machines in China)
[Contents of the commission] Production of application materials, production of quality management procedures, assistance with government office management, and issues assigned during office management.
[Required time] Approximately 6 months after completion and confirmation
[High points] Customers have not obtained ISO13485 quality system certification, fully assisted customers to complete domestic ISO13485 quality system certification, and successfully removed Japan certification system.
✓ Company B (EC Electronics Company/Blood Company)
[Project] China's bloodstream system exits to Japan, Pingtai electronic music company located in Japan
[Contents of the commission] Production of application materials, production of quality management procedures, assistance with government office management, and issues assigned during office management.
[Required time] Approximately 8 months after completion and confirmation
[Good point] In the first half of the first period, the customer service was completed, the medical equipment was certified, and the Japanese wireless phone certification was completed in a large amount of time.
✓ Company C (Medical equipment trading company/Medical equipment)
[Project] Due to the outbreak of the epidemic, medical services provided by the Japanese Ministry of Health, Labor and Welfare due to urgent customer demand
[Contents of the commission] Production of application materials, production of quality management procedures, assistance with government office management, and issues assigned during office management.
[Required time] Ready to be completed and confirmed
[Bright points] Due to the urgent situation, the administrative department has confirmed that the final product report has been approved.
6. Discrepancies among other companies
| Gashi | Others A (Administrative Register Office) | Others B (medical equipment) | |
| Chinese translation | ◎ (Medical Chinese translation) | × (limited to Japanese) | × (limited English translation) |
| administrative office | ◎ | ◎ | × |
| Supplementary notice | ◎ | ◎ | × |
| Quality management process manual production | ◎ | ◎ | ◎ |
| Joint venue training | ◎ | ◎ | △ |
| body mass | Around 4 | 1~2 people left and right | 4~5 people left and right |
7. Plans (hereinafter referred to as 2 categories of medical equipment)-1 item example)
[Method 1] Qualification + Product Certification + QMS Compatibility Tuning
- Support for foreign manufacturing business orders
- Medical equipment manufacturing sales and manufacturing industry approval
- Product certification book production and STED production
- Each question specified by the administrative agency
- Establishment of quality management procedures (repairs and revisions) and support for record production
- Quality management procedure and practical training
- On-site training support
From 350 million yuan
[Method 2] Product certification + QMS compliance check
- Product certification book production and STED production
- Questions regarding the administration and administrative matters in each category
- Establishment of quality management procedures (repairs and revisions) and support for record production
- Quality management procedure and practical training
- On-site training support
From 250 million yuan
[Method 3] QMS application specifications
- Establishment of quality management procedures (repairs and revisions) and support for record production
- Quality management procedure and practical training
- On-site training support
From 80 million yuan
Contact Information
[Company information]
Support Gyoseishoshi Law Firm
Shinjuku Headquarters Shinjuku Monorisu 2F, 3-1-2 Nishi-Shinjuku, Shinjuku-ku, East Kyoto
Akihabara branch store GYB Akihabara 2F, 25-8 Kanda-kayoda-cho, Chiyoda-ku, Higashi-Kyoto
Nagoya Branch Mitsui Building Main Building 1F, 24-30-18 Nakanan, Nakamura-ku, Nagoya
Osaka Branch Doshima Avanzar 1F, 6-20-6 Doshima, Kita-ku, Osaka
Company main page:https://www.shigyo.co.jp/company
We also provide services for various categories, employment of foreign employees (residency status, etc.), application for subsidies, etc.
Information that we receive from you at any time.
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