Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD), which has gone into effect on June 1, 2021.

The online event is held in cooperation with our close partner ISS AG from Switzerland and is scheduled to be held on June 30th (Wednesday), 2021. Depending on your place of location, the webinar will start at:
- 10am (Central European Summer Time),
- 4pm (GMT+8) local time in Taiwan,
- 5pm (GMT+9) local time in Japan.

Shall this Webinar be of interest to you or one of your colleagues, please be sure to register for the event using the following
Sign-Up Link (limited seats available).

Webinar Agenda:
Given the recent implementation of the new China Regulations for Supervision and Administration of Medical Devises (RSAMD), this webinar will ensure that you are aware of all the important changes:

1. NMPA’s (Regulatory) Measures to Encourage Innovative Medical Devices:
- 1.1. Simplified and Priority Review Pathways and Approval Procedures,
- 1.2. Conditional Approval Pathway,

- 1.3. Encouraging the Undertaking of Clinical Trials of Innovative Medical Devices.

2. New Obligations for Product Registrants under the new Nationwide Adopted Marketing Authorization Holder (“MAH”) System.

3. Risk and Quality Management: MAH’s Responsibilities for the Safety, Quality, and Efficacy of the MD Throughout its Entire Life Cycle.

4. Reform in Clinical Evaluation Requirements and Broader Exemption from Clinical Evaluations.

5. Improvement of the Supervision System and Enhancing Enforcement via an Increase in Penalties for Committed Violations.

Speaker Introduction:

Mr. Ryan Lu  – China NMPA Registration Expert, Qualtech Beijing

Mr. Ryan Lu is one of Qualtech’s China NMPA registration experts with multiple years of experience. Representing one of the key members in Qualtech’s Beijing Branch, Mr. Lu has significant expertise in the registration of active and non-active medical devices with the Chinese NMPA authorities.

Mr. Lu's educational background is situated in the field of Biomedical Engineering, having obtained his master’s degree from the well-known National Tsing Hua University.

If you have any questions regarding the event, feel free to contact us by mail at 
Christian.s@qualtechs.com or by phone at +886-2-2740-1778.