Medical Device Registration and Approval in China
zzgl. MwSt.
- Virtual Classroom-Preis: 616.55 € zzgl. MwSt.
- Dauer: 1 Tag (von 09:00 - 17:00 Uhr)
- Servicebausteine: im Wert von 199.80 €
- Artikelnummer: S236
- Max. Teilnehmer: 15
- Kursform: Präsenz oder Virtual Classroom
- Seminarinfo: PDF-Download
- Inhouse: Ihre unverbindliche Anfrage
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Nächste Termine:
Live Virtual-Classroom-Training-27.10.-27.10.22.Yue Li
Alle Termine anzeigen
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Weitere Kursformate:
In this seminar, we introduce you to the key points of the Chinese medical device registration process. Moreover, we familiarize you with the legal and normative requirements for the successful approval of medical devices in China. Another topic of this training is the mandatory registration test for Class II and Class III medical devices. In this context, we inform you about the test process and show how you can establish a Clinical Evaluation Report (CER). China owns one of the largest healthcare industries, thus becoming more and more attractive for foreign manufacturers.
The competent authority responsible for the medical device registration is the National Medical Products Administration (NMPA) - formerly China Food and Drug Administration or CFDA. The requirements of the NMPA for the approval of medical devices are constantly reinforced, thereby making the registration process more challenging. At the end of this training, you will be familiar with the registration requirements as well as their implementation. In addition, you will have the opportunity to exchange experiences and discuss the topic with our experts and other participants.
Was sind Ihre Inhalte der Ausbildung Medical Device Registration and Approval in China?
Content of this training
In this course we introduce you to the requirements for the approval of medical devices in China. First of all, we provide you a short overview of the medical device industry in China. Following that, we lead you through the complete registration process, thereby explaining all important key points.
- Current status of the medical device industry in China
- Normative and regulatory requirements for the registration process
The registration process for the approval of medical devices in China
At this point of the seminar we lead you through the registration process. You will be informed about the different steps of the NMPA registration process for medical devices and learn how to initiate a compliant Clinical Evaluation Report (CER). Furthermore, we discuss the required technical documentation.
- Classification of medical devices according to the NMPA guideline and NMPA classification database
- Steps of the NMPA registration process for medical devices
- Testing requirements - type testing and industry standards
- Developing a Clinical Evaluation Report
- Market Inspection
- Labeling of medical devices
- Infringements and their consequences
Welches Zertifikat erhalten Sie in diesem Medical Device Registration and Approval in China Kurs
Qualification certificate:
On conclusion of the training, all participants receive a qualification certificate for the participation on the training "Medical Device Registration in China - NMPA requirements" in German and English.
Objective of this training: This training provides an...
Target group: This seminar addresses manufactures of medical...
Prerequisites: There are no necessary prerequisites.
Was ist das Ziel und welche Zielgruppe sprechen wir an?
Objective of this training:
This training provides an overview of the medical device registration process in China. We inform the participants about the essential regulatory requirements of the National Medical Products Administration (NMPA) for the approval of medical devices.
Target group:
This seminar addresses manufactures of medical devices who want to launch their products to the Chinese market. Moreover, it aims at engineers and personnel in charge of regulatory affairs and the quality management in the medical device industry.
Prerequisites:
There are no necessary prerequisites.
Ihre Servicebausteine in diesem Medical Device Registration and Approval in China Kurs:
Als Kursteilnehmer erhalten Sie folgende Servicebausteine im Rahmen Ihrer Kursteilnahme. Diese Bausteine sind im Seminarpreis bereits enthalten und unterstützen Sie mit zusätzlichen Inhalten und Musterdokumenten zu Ihrem Kursthema. Den monatlichen Expertenbrief erhalten Sie erstmalig im Anschluss an Ihre Teilnahme. Dieser informiert Sie monatlich über aktuelle Fachinfos zu Ihrem Kursthema.
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