Digital Therapeutics 'First Lesson of the School Year' | MedTech CRO Safeguards Your Path to Market

The wave of digital therapeutics has swept from overseas markets into China. However, to succeed in the Chinese market, companies must master three key elements: regulatory approval, distribution channels, and operations. Among these, regulatory approval is particularly critical as a major threshold for the future large-scale commercialization of digital therapeutic products. Currently, Chinese regulatory authorities have not yet established specific approval requirements for digital therapeutics. Although digital therapeutic companies possess innovative products, they face numerous challenges in accelerating market entry, such as determining where and how to obtain regulatory certification.

As the new school season arrives, VCBeat has joined hands with Tigermed Jietong, a leading CRO in the medical device sector, to carefully prepare the “First Lesson” on digital therapeutics for you, bringing you insights into digital therapeutics.A Comprehensive Analysis of the Entire Product Certification Process: Formulating Registration Strategies, Designing Clinical Trials and Sharing Best Practices, and Key Points for Registration Submission and Approval, providing answers to relevant enterprises' questions and helping you avoid detours and missteps on the path to approval.

This course will be conducted entirely via live online sessions. The schedule is as follows:

By joining the "First Lesson of the Semester" Device CRO Workshop for Digital Therapeutics, you will gain:

One-Stop Guide to Digital Therapeutics Products: From Strategy Formulation and Clinical Trial Design to Regulatory Approval

Tigermed Jietong’s In-House Experts Present Case Studies on the Approval of Digital Therapeutics in China and Abroad, Offering Comprehensive Insights and Lessons Learned

Tigermed Jietong, Senior Director of Regulatory Affairs

Responsible for regulatory affairs and product registration across various segments of the medical device industry, both domestically and internationally. As a Regulatory Affairs Expert with over 15 years of experience in the medical device registration sector, has managed more than 4,000 registration projects and participated in the certification process for the first batch of digital therapeutics products in China.

Senior Director, Clinical Operations Department, Tigermed Jietong

Responsible for the clinical trial operations of domestic and international medical devices, led the team in undertaking multiple clinical research projects for innovative medical devices, possesses extensive experience in clinical trial operations, with over 15 years of industry experience, and participated in the certification process for the first batch of digital therapeutics products in China.

Director, Tigermed Jietong System Services Department

Expert in medical device regulations and medical device quality management systems (GMP). Previously served at the Medical Device Division of the Beijing Municipal Drug Administration, where he engaged in medical device regulatory work for over ten years and participated in the certification process for China’s first batch of digital therapeutics products.

Senior Project Manager, Regulatory Affairs Department, Tigermed Jietong

Responsible for registration and type testing of active medical device products both domestically and internationally; has over 10 years of experience in the medical device registration industry, and participated in the regulatory approval process for China’s first batch of digital therapeutic products.

Tigermed Jietong, Medical Affairs Department, Medical Affairs Manager

Responsible for clinical evaluation and clinical trial design of medical device products both domestically and internationally, having overseen more than 60 clinical evaluation projects and over 40 clinical trials. Participated in the regulatory approval process for China’s first batch of digital therapeutics products.

Tigermed Jietong, Medical Affairs Department, Senior Medical Editor

Responsible for clinical evaluation and clinical trial design of medical device products both domestically and internationally, with experience in over 50 clinical evaluation and clinical trial projects for medical devices. Participated in the certification process for the first batch of digital therapeutics products in China.

1.  Digital Therapeutics Entrepreneurs, committed to developing prescription digital therapeutics (PDT) products in the future, and eager to drive innovative transformation in the healthcare industry through cutting-edge technology;

   
   

2. Medical Device CROs, Pharmaceutical and Medical Device Companies, closely monitoring emerging trends in digital therapeutics and eager to drive the commercialization and industry development of digital therapeutics.

First, we consider this a valuable opportunity for exchange regarding regulatory compliance and approval guidance for digital therapeutics. Meanwhile, we aim to reduce costs for entrepreneurial partners who are eager to learn. In light of the special circumstances, this course will be delivered via live online streaming, with a limited-time discount available!From now until September 28, scan the QR code to enjoy a course originally priced at ¥999 for just ¥1!

1. To register, please click the link below or scan the QR code.

Registration Link:http://nxw.so/5FQD3

(Click to Register)

Note:Please scan the QR code to follow[Digital Therapeutics CDTSP]Successfully followed the WeChat Official Account.Course Column, click the column to enjoyPurchase the training course, originally priced at ¥999, for just ¥1。

2. To ensure the smooth conduct of the course, please contact the staff listed below if you have any questions.

Course Inquiry: Ms. Zou zl90weixin (WeChat ID)

3. Complete the study (September 2–September 28), completing a total of 5 course sessions.

Tigermed Jietong, a wholly-owned subsidiary of Tigermed (Stock Codes: 300347.SZ/3347.HK), was established in 2000. It is China’s most capable innovative contract research organization (CRO) specializing in regulatory affairs and clinical studies for medical devices (including in vitro diagnostic products). As the largest domestic provider of regulatory consulting and clinical study services for medical devices, it covers the entire lifecycle across all sectors of the medical device industry.

Over the past 20 years, Tigermed Jietong has established long-term partnerships with more than 1,700 medical device R&D and manufacturing enterprises from over 30 countries. Leveraging its professional service capabilities, the company helps clients mitigate registration risks, shorten project timelines, reduce R&D costs, and accelerate product commercialization.