HOW WILL THE NEW DECREE ON MEDICAL DEVICE MANAGEMENT AFFECT YOUR BUSINESS IN VIETNAM FROM 2022?
- Are you researching about how to register your medical devices with Vietnamese Ministry of Health which give you pathway to the market constituting nearly 100 million people?
- Have you ever heard of a “game-changing” legislation that supersedes the current applicable Decree No. 36/2016 and its supplements on procedures for marketing authorization registration of medical devices?
- Are you wonder how to classify risk management for medical devices; how to apply for MA Codes under fast-track procedures; or how declare pricing policies in compliance with the new regulations?
Let’s our Legal Experts do your work!
VIETNAMESE MEDICAL DEVICES REGULATORY FOR 2022
– GAME CHANGES AND ADAPTATION SOLUTIONS
Premium Package
▪️Specially designed for each company’s flagship products.
▪️Update and elaborate on the noteworthy points of Decree No. 98.
▪️Address in details to any questions corresponding to the specific product lines of your business.
▪️You are free to choose a time frame which suits to your local business hours.
▪️No limit to the number of employees of one company may join.
Duration: 90 minutes of presentation and 30 minutes for Q&A section
Language (to be pre-ordered): English or Vietnamese
Service fee: VND 60 million per section
Exclusive offer: Immediately refund 50% of the service fee of this Premium Package for the next bill which worth more than VND 50 million if you choose to use any of MedNovum’s marketing authorization registration services within 30 days after the Webinar.
Open Package
▪️Generally designed for all types of medical devices.
▪️Update and elaborate on the noteworthy points of Decree No. 98.
▪️Discuss publicly among registered attendees about their regulatory concerns.
▪️The webinar time frame is pre-fixed according to the office time of most registered attendees.
Duration: 90 minutes of presentation and 30 minutes for Q&A section.
Language (to be pre-determined later): English or Vietnamese
Admission fee: VND 10 million per attendee
Exclusive offer: Immediately refund 50% of the Admission Fee against the next bill which worth more than VND 20 million if you choose to use any of MedNovum’s marketing authorization registration services within 30 days after the Webinar.
Discount 10% on the service fee of Premium/Open Package for customers who used to use MedNovum’s services
WHO IS THE HOST?
HIEU NGUYEN
Lawyer – Master of Law
Education:
– Bachelor of Laws (2006), Ho Chi Minh City University of Law, Vietnam
– Master of Laws (2015), Ho Chi Minh City University of Law, Vietnam
– Lawyer Practicing Certificate (2008), Ho Chi Minh City Bar Association, Vietnam
– Certificate of Medical Devices Risk Classification (2017), College of medical device technology, Vietnam.
Background:
Lawyer Nguyen Trung Hieu has worked for several prestigious law firms, including MayerBrown JSM (Vietnam) and LCT Lawyers (now, LNT&Partners), before founding and operating LexNovum Lawyers in 2011.
Hieu and his colleagues have been building and developing MedNovum since 2016, with the focusing on legal services for the marketing authorization of medical device in Vietnam under the umbrella of Decree No. 36/2016. Since 2017, MedNovum has (i) maintained a strong market share in the segments of medical device risk classification and (ii) provided in-country representative service to the numerous owners of medical device (so called “MA Holder service”) and marketing authorization registration service in Vietnam.
Should you need more information about the Webinar or one of the offered packages, please do not hesitate to contact us via email: info@mednovum.com.vn or immediately call our hotline +84 28 3911 1551 (for Vietnam-based clients) or +1 (647) 764 – 0680 (for others – WhatsApp is preferred).
REGISTER NOW
After your registration, you will receive your registration confirmation by email from MedNovum with webinar information within 24 hours. If there is something wrong with the registration information, please contact MedNovum for assistance.