Master Global Medical Device Registration: eLearning with Personal Coach & Job Placement Boost

Keyword

Medical Device, in vitro diagnostic, State Council Ordinance, China Food and Drug Administration, National Medical Products Administration, NMPA, regulatory affairs, technical document, risk management, verification and validation, RPS, UDI, change registration, marketing authorization holder, overseas manufacturer, overseas factory inspection, outsourced manufacturing, type testing, product technical requirement, usability validation, clinical evaluation, instruction for use, labels, adverse event, vigilance, Quality management system, 医疗器械, 指导原则, 质量抽查, 说明书和标签, 体外诊断试剂, in vitro diagnostics, MDR, FDA, MDSAP, Taiwan, eSTAR, conformity assessment, ANVISA, Kaizen, global registration, regulatory intelligence, webinar, online university, template, on-demand workshop

Another definitions s. Encyclopedia

Have you tried regulatory affairs webinars or online courses that lacked personal guidance? Our "MyCompliance" eLearning solves the #1 frustration: no interactive coaching.

With our eLearning "MyCompliance" for regulatory affairs of medical device (IVD) you have your own coach all the time, case study and regular personal meetup.

New

All interested person could pick up free-to-attend 3 sessions among learning material below. Every month we have limited spots due to capacity.

It could be combined with advanced eLearnings of regualtory affairs, meet with coach, workshops, gifted templates and test with certificates.

Session 1: Chinese access of medical device

In this session you will learn the basic knowledge of Chinese registration of medical device and IVD.

1.0 Roadmap of Chinese registration (free)

1.1 Chinese authority: NMPA

1.2 Chinese agent

1.3 Chinese certificate

1.4 Type of registration

1.5 Classification and product code

1.6 Time and cost

Session 2: Registration in China

In this session we will dig deeper to important steps prior to and during the Chinese registration of medical device and IVD.

2.1 Type Testing

2.2 Product technical requirement

2.3 Technical documentation

2.4 Clinical study and clinical trial

2.5 Chinese labelling

2.6 Change registration

2.7 Deficiency Reply

Session 3: Chinese Post market and quality management

After product approval by authority you should know the post market and quality management activities in Chinese market.

3.0 Post market surveillance

3.1 Chinese vigilance system

3.2 Significant change

3.3 Periodic Risk Evaluation Report

3.4 Annual self-inspection report*

3.5 Chinese GMP

3.6 Overseas inspection

Session 4: Global markets of medical device

We will gain some global impression how the registration of medical device and IVD in other markets look like.

4.0 Global registration

4.1 From MDR in Europe to NMPA in China

4.2 Legislative (free)

4.3 Quality management renewal

4.4 Change registration/notification

4.5 International vigilance

4.6 From FDA to NMPA

4.7 Swich bw FDA and MDR

Session 5: Regulatory Affairs Soft Skills

The soft skills of regulatory affairs is the key besides regulatory know how.

5.1 Regulatory affairs soft skills

5.2 Kaizen in regulatory business

5.3 Project management

5.4 Communication skills

Session 6: Regulatory intelligence

This is unique session after which your career as regulatory affairs manager or head will be boosted.

6.1 Influence product certificate

6.2 Consolidated international technical documentation

6.3 Navigate of international database at authority site

6.4 Group of severe product models and variants

6.5 Equivalent products (own and from competitor)

6.6 Stakeholders (M&A sponsor, user, importer, distributor, legal representative, oursourced partner)