Are you a medical device manufacturer seeking to expand your business to Vietnam? Express Vietnam can help you with the lengthy, challenging, and time-consuming paperwork.
As a trusted provider of visa and business application services in Vietnam, Express Vietnam can help you in every step of the medical device registration process. Here’s how we can the process easier for you:
Expertise in Local Regulations: Vietnam’s regulations on medical device registration are complex and often changing. Express Vietnam has a team of local experts who are familiar with the latest regulations and can assist you in ensuring that your medical devices comply with the requirements.
Before you can even legally operate, all medical devices must go through the registration with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health.
Streamlined Documentation Process: Medical device registration requires a significant and lengthy paperwork. Express Vietnam can help you prepare all the necessary documentation, ensuring everything is in order before submitting your application.
All medical device registrations undergo a risk and result assessment, where classification will be determined. Following the guidelines under Decree 98/2021/ND-CP, the registration process goes through the DMEC portal then you’ll receive your circulation registration certificate afterward. You may also need to present your legal and technical requirements, such as your free sale certificate, letter of authorization, ISO 13485 certificate, technical brief, instructions on how to use, and clinic data for lower classes.
Efficient Communication with the Authorities: Express Vietnam can act as a liaison between you and the relevant authorities, helping you navigate potential roadblocks and ensuring your application is processed smoothly and efficiently. We’ll also update you on any changes during your medical device registration.
Timely Processing: With Express Vietnam’s assistance, you can expect your medical device registration application to be processed promptly. This allows you to start selling your products in Vietnam as soon as possible.
The process can take 7–10 working days for classes A and B and may take 6–12 months for classes C and D.
Since you’re completely engaged in doing business in the country, you may also need to consider getting a Business Visa or Investor Visa in Vietnam so you can continuously monitor your business operations onsite.
With Express Vietnam, you can simplify the process and ensure that your products are registered and ready to go live in the Vietnamese market. Get in touch with Express Vietnam today to learn more about the product registration process or visit their website for more information.