Expansion of medical devices from China into Japan

Updated: July 2025, 10

1. Are you having trouble?

Chinese manufacturers (foreign manufacturers) and importers (medical device manufacturers and distributors) need to work closely together, and dealing with unfamiliar administrative and certification bodies requires a huge amount of time, effort, and personnel.

Please take advantage of the support administrative scrivener corporation's "Medical Device Expansion Support in Japan"!

2. Main support contents

Product investigation and reporting

Preliminary investigation of the applicability of certification standards, existence of similar products, procedure flow, period, cost, etc.

smooth communication

Intervene between Chinese manufacturers, importers, and government/certification bodies, supporting smooth communication from a third-party perspective.

Document preparation (including the creation of procedure manuals)/Application

Support for creating a set of application documents, attached documents (STED), and procedures and records necessary for QMS compliance investigation

Make the application on your behalf and manage it until completion

Implementation of study sessions on procedure manuals and on-site investigation measures

In preparation for the field survey, we will give you a lecture on how to use the procedure manual, and provide you with a solid preparation for the field survey.

On-site survey support/improvement report

We will be present during on-site inspections, provide on-site response, provide prompt support in emergencies, and provide support from correcting deficiencies to reporting after improvements.

Project management/registration content management

We set an application schedule with plenty of time until product certification and manage the project.

3. Reasons for choosing Support Administrative Scrivener Corporation

A team of experienced experts leads the project to speed up the certification process.

[Frequently asked problems]

　・A huge amount of time, effort, and personnel tend to be spent on unfamiliar responses.

　- Projects often stall due to lack of problem-solving know-how.

　・Redoing procedures costs time and money.

▼Support administrative scrivener corporation

✓ Clear application flow allows you to proceed according to schedule.

Our consultants can communicate in Chinese.

[Frequently asked problems]

　・Communication is difficult due to language

　・Project stagnates due to lack of trusting relationships

　・Unable to get used to the way business is done in China, causing many troubles

▼Support administrative scrivener corporation

✓Communicate directly with Chinese manufacturers and collect necessary documents.

✓Perform certification work from a neutral third-party standpoint, unaffected by business product agency contracts, etc.

4. Benefits of requesting

[1] You can focus on “what your company needs to do”

Has extensive experience negotiating with certification bodies.

We will help you prepare for the field survey, attend the survey, and report on improvements to eliminate your concerns.

▶ You can use your time for business activities other than applying for certification.

[2] Reliable support from a team of medical device certification experts

Our company is a legal practitioner corporation with bases in Tokyo, Nagoya, and Osaka.

We proceed with advance preparations and arrangements that take into account the characteristics of the product and key points of the project.

▶ You can reduce wasted time and costs and obtain certification smoothly.

[3] Eliminate communication costs due to language differences

Available in Chinese and Japanese.

We work directly with product manufacturers.

▶ Minimizes the stress of communication, regardless of language issues.

5. Past results (partial)

✓ Company A (trading company specializing in home appliances/massage equipment)

　[Project] I would like to import and sell Chinese massage devices in Japan.

　[Request details] Application form creation, procedure manual creation, on-site survey support, response to inquiries

　[Period] 6 months from preparation　

　[Point] The Chinese manufacturer had not acquired ISO13485, and in order to avoid the on-site inspection by the Japanese certification body, we negotiated with the manufacturer to obtain certification in China and were able to avoid the on-site inspection by the Japanese certification body.

✓ Company B (EC sales company/pulse oximeter)

　[Project] I would like to import Chinese pulse oximeters to Japan and sell them on an EC site.

　[Request details] Application for business license, preparation of application for product certification, preparation of procedure manual, on-site investigation support, response to inquiries

　[Period] 8 months from preparation　

　[Points] The product had a Bluetooth function, but by knowing in advance that it was necessary and making preparations at the beginning, we were able to avoid time loss and obtain the Technical Conformity Mark certification.

✓ Company C (medical equipment trading company/surgical gloves)

　[Project] It is necessary to urgently import surgical gloves as a special demand for the coronavirus and deliver them to the Ministry of Health, Labor and Welfare.

　[Request details] Application for business license, preparation of application for product certification, preparation of procedure manual, on-site investigation support, response to inquiries

　[Period] 2 months from preparation

　[Key Points] As an emergency response to the coronavirus pandemic, we coordinated schedules with the government and achieved certification in the shortest possible time.

6. Differences from other companies

1. Plan (Class XNUMX managed medical device/XNUMX item example)

[Plan 1] Business license acquisition support + product certification application support + QMS compliance investigation support

　・Foreign manufacturer registration application support

　・Medical device manufacturing/sales business/manufacturing license application support

　・Certification application creation/STED creation support

　・Response to inquiries

　・Procedure manual creation (or revision) ・Record creation support

　・Procedure manual operation training ・On-site investigation support

Compensation: 350 million yen~

[Plan 2] Product certification application support + QMS compliance investigation support

　・Certification application creation/STED creation support

　・Response to inquiries

　・Procedure manual creation (or revision) ・Record creation support

　・Procedure manual operation training 　

　・On-site investigation support　　　　　　　　　

　　　　　　　　　　　　　　　　　Compensation: 250 million yen~

[Plan 3] QMS compliance survey support only

　・Procedure manual creation (or revision) ・Record creation support

　・Procedure manual operation training

　・On-site investigation support

Compensation: 80 million yen~

Contact

 　Medical Device Team Chief Consultant Li Bowei

　 Direct: 070-5652-3699

 　email address :　ri.haku@shigyo.co.jp

[Introduction]

Support Gyoseishoshi Law Firm

[Tokyo Head Office] Shinjuku Monolith 2F, 3-1-25 Nishi-Shinjuku, Shinjuku-ku, Tokyo

[Nagoya Branch] Mitsui Building Main Building 1F, 24-30-18 Meieki Minami, Nakamura-ku, Nagoya City

[Osaka Branch] Dojima Avanza 1F, 6-20-6 Dojima, Kita-ku, Osaka

　Our homepage:　https://www.shigyo.co.jp/company

　We also provide support for various permit procedures, utilization of foreign employees (residence status, etc.), and utilization of subsidies.

　The first consultation is free.