TÜV SÜD Japan E-learning
TÜV SÜD Japan E-learning
On-demand Webinar / E-learning
（Local Medical Device Related Program）
Overview
This on-demand webinar program provides an essential overview of Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), focusing on its requirements and compliance obligations specifically for manufacturers outside of Japan. Participants will learn about regulatory frameworks, product approval (Shonin / Ninsho / Todokede), QMS and post market surveillance applicable to products entering the Japanese market. This webinar is designed to help overseas manufactures understand and navigate Japan’s regulatory landscape to ensure smooth market entry and maintain compliance with the PMD Act.
The webinar also briefly covers in vitro diagnostics, making it suitable for both medical device manufactures and invitro diagnostic (IVD) manufactures.
Each participant will receive a training attestation after passing the confirmation test and submitting the survey. This training attestation may serve as evidence of having completed the PMD Act Basic Training.
Watch Teaser
Training Outline
Section 1: PMD Act Regulatory Framework
Section 2: Marketing Certification Process Overview
2-1: Marketing Certification Process Overview
2-2: License and Registration
2-3: QMS/GVP and Legal Compliance System
2-4: Quality Management System
2-5: QMS Conformity Attestation
2-6: Product safety and Efficacy
2-7: Marketing Certificate
Section 3: Post Certification Activity
3-1: Changes
3-2: QMS Surveillance
3-3: 5-year QMS Audit
3-4: License and Registration Renewal
3-5: Vigilance
3-6: Advertisement Requirements
Section 4 : Other Topics
Course Duration
Section 1: 17 minutes 23 seconds
Section 2: 54 minutes 36 seconds
Section 3: 13 minutes 1 second
Section 4: 9 minutes 12 seconds
Confirmation test: 4 Questions
Survey
Watch Sample
Training Attestation
A training attestation will be issued upon passing the final exam and submitting the survey.
The training attestation will be issued online (available for download).
Training Fees
A registration enables up to 5 people to undergo the training during a period of 2 months. An additional fee will be charged for every additional participant. Please refer to the following price list.
| Number of People | Accessibility Period | Price |
| Up to 5 people | 2 months | 300,000 JPY |
| Per additional person | 2 months | 20,000 JPY/person |
Notes:
※ The training program is accessible for a period of 2 months after the access rights are granted.
※ The training can be repeated as many times as necessary during the period of 2 months.
※ After receiving the list of participants with the application, we will issue an invoice. Once the payment is confirmed, access rights are granted by issuing ID and password.
※ Each participant is notified individually about their ID and password via e-mail.
※ If the applicants belongs to different legal entities, please submit a separate training application for each entity.
※ The training start date is the first day of each month, and the payment cut off date is the 20th of the previous month.
Example: in case the payment is completed on 20th Aug, the training can be started from 1st Sep. If the payment is completed on 21st Aug, the access to the training will be granted from 1st Oct.
※ Any bank transfer fees must be borne by the sender to ensure full payment is received.
※ A training attestation is included in the training fee. The attestation will be issued upon passing the confirmation test and submitting the survey.
※ Please note that registrations by individuals from competing companies or involved in consulting are respectfully declined.
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