How Express Vietnam Can Simplify Your Medical Device Registration Process in Vietnam

Medical Device Registration

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.

Everything You Need to Know About Establishing a Representative Office in Vietnam

Representative Office

Expanding your business in Vietnam? It’s a bold and strategic move. A representative office is a foreign company that acts as a liaison between the company and its clients in Vietnam. Indeed, it is the most cost-effective way to enter and understand the Vietnamese market before making a large investment in the country. When you proceed with this arrangement, you do not need a huge amount of capital and don’t need to register as a separate legal entity to begin your business activities in Vietnam.

Setting up a representative office in Vietnam can be complicated and time-consuming, especially if you are a first-time entrant who needs to become acquainted with the country’s business laws and regulations. Well, you don’t have to think too long or too hard because Express Vietnam has a team of experts who can guide you through the process, ensuring your office is set up smoothly and quickly.

In this blog, we’ll share everything we know about establishing a representative office and how Express Vietnam can assist you.

What activities are permitted for the Representative Office?

Representative Offices, or ROs, can perform the following actions:

  • You can conduct research on the market.
  • You act as an intermediary or liaison between its parent or foreign company.
  • You can promote the products and services of its parent or foreign company via meetings and other business-related events.

They are not permitted to engage in contract negotiations, issue invoices, or generate revenues.

 Who are eligible to register for a Representative Office?

According to Decree No. 07/2016/ND-CP (Trade Law on representative offices, branches of foreign businesses in Vietnam), foreign investors can acquire a license for registering a Representative Office if they meet the following criteria:

  • The companies are from foreign countries or territories that are signatories to treaties with Vietnam.
  • They have a valid business registration certificate or equivalent that was obtained within one year of application submission.
  • Their operational activities are following the laws of the country in which they are based.

What is the pre-licensing checklist for establishing a Representative Office?

To set up a Representative Office, the following pre-licensing checklist must be completed:

  • File an application for setting up a Representative Office with the company seal.
  • Provide the appointment letter of the Chief of the Representative Office along with their identification documents and company seal.
  • Give power of attorney in favor of a consultant to submit the application dossier.
  • Provide the Certificate of Incorporation for the Company and/or Business Registration Certificate of the Company.
  • Present the audited financial report of the company for the latest fiscal year.
  • Provide the Memorandum of Understanding (MoU) for leasing the office or the leasing contract.
  • Present documents that provide the legal rights of the landlord regarding the right to lease the office.

For steps 1-6, the foreign entity must provide one notarized and consularized copy of each document along with a translated copy in Vietnamese by a Vietnamese competent authority.

Additionally, a signed leasing contract is necessary before registering a Representative Office in Vietnam.

What is the post-licensing checklist for establishing a Representative Office?

To complete the post-licensing process for setting up a Representative Office, the following checklist must be completed:

  • Create a seal for the RO: Obtain a license for the establishment of the RO, and provide the passport of the Chief of RO (if foreign) or the passport/ID card (if Vietnamese).
  • Register for a tax code for the RO: Declare the registration of the tax code; provide a Power of Attorney; obtain a Certificate of Seal registration; and obtain a Certificate of RO in Vietnam.
  • Open a bank account for the RO: A license for the RO establishment; a certificate for registering the seal;  a certificate for registering the tax code; and a letter appointing authorized signatories for the bank accounts.
  • Announce the establishment of the RO of the company.

Notarized and translated documents will be required for steps 8–10 to complete the process. 

With the help of Express Vietnam’s professional guidance and support, you can establish your representative office in Vietnam swiftly and effectively, giving you more time to concentrate on expanding your enterprise one region at a time. Reach out to our experts now to explore further how we can support you in setting up your representative office in Vietnam. You can also visit this page for more information.

Breaking Down the Process: How Express Vietnam Can Help You Set Up Your New Company in Vietnam

Breaking Down

Are you thinking about establishing a new company in Vietnam? Vietnam is becoming an increasingly attractive destination for entrepreneurs and investors due to its flourishing economy and business-friendly legislation. Yet, understanding the business registration procedure can be difficult, especially if you are unfamiliar with the local rules and regulations.

Starting a business can present a formidable challenge. However, you need not be concerned. Express Vietnam, a prominent provider of Vietnam visa and business services since 2017, will aid you in effectively navigating this process.

We’ll walk you through the company registration in Vietnam and show you how Express Vietnam can assist you in this detailed guide.

Choose your business structure.

Express Vietnam will assess which business structure works for you at the outset of company creation based on your operations, demands, and criteria. There are two common business types: A limited liability company (LLC) and a joint stock company (JSC). An LLC corporation can employ up to 50 people, including founders and business owners, without the requirement for shareholders, while JSC, or joint stock company, must have a minimum of three shareholders.

Get your IRC, or Investment Registration Certificate.

Express Vietnam will help you acquire your IRC (Investment Registration Certificate) from the Department of Planning and Investment (DPI). in the province where you will operate. The process applies to foreign-owned enterprises, and it takes 25 business days to complete.

In addition, we will request a few prerequisites from you to expedite the certificate in a seamless and timely way; these are:

  • Application Letter for implementing an investment project
  • Proposal for an investment project
  • Power of Attorney to staff for IRC
  • Demonstration of the investor(s)’ financial capability
  • Bank statement
  • Copy of passport of foreign investors

Get your ERC, or Enterprise Registration Certificate.

Express Vietnam will assist you in acquiring your ERC, or Enterprise Registration Certificate, once you have obtained your Investment Registration Certificate, which is a requirement for businesses. In addition, before the department may award the certificate, you must complete the following requirements:

  • Application Letter for incorporation of the VN company
  • Charter of Vietnam Company
  • Power of Attorney to staff for ERC
  • List of members, foreign investors
  • Passport copies of legal representatives, individual investors
  • Investment Registration Certificate

Pay your taxes.

You must pay your taxes using an online system before your business may begin operations. Your business registration certificates include a number, which is also your legal tax identification number. Express Vietnam may assist you in gaining access through the online system, which just takes an electronic signature, and ensuring that you are completing your due diligence by adhering to tax requirements.

Make your capital contribution.

You have 90 days to make a capital contribution, whether you are a business owner or an investor, or you may suffer a penalty. 

Apply for permits or sublicenses depending on your industry.

If you are in the manufacturing, logistics, recruitment, lodging, or trading industries, you may need to obtain a sublicense, which can lengthen the procedure. Express Vietnam will handle all of your permissions and processes under the law.

Ready to take your business to the Vietnamese market? Express Vietnam is here to help provide relevant guidance and support you need on this journey. Skip all the lengthy paperwork, legal complexities, and numerous fees, we’ll do the legwork for you.

Fill up the Business Service Application Inquiry, and our team of experts will contact you.

If you’re an investor in the company, you must acquire an Investor Visa for Vietnam, which can last up to a decade depending on your DT category.

Express Vietnam is pleased to offer Vietnam visa services whether you’re applying in Vietnam or your home country. Check out this page for more information on the qualifications for obtaining your Investor Visa.

Vietnam’s Growing Economy

Vietnam's Growing economy

Over the past few decades, Vietnam has experienced rapid economic growth, making it one of Southeast Asia’s fastest-growing economies. Vietnam has transformed itself from an agrarian nation into a thriving center for industry, trade, and innovation. Throughout this blog, we will examine the factors that have driven Vietnam’s remarkable economic transformation, and what lies ahead for the country.

The favorable policy environment created by the government has been one of the key factors behind Vietnam’s economic growth. As a result of economic liberalization, the country has worked to create a business-friendly environment that encourages foreign investment and entrepreneurship. A modern and dynamic economy has also been built through government investments in infrastructure, education, and human capital.

Growth in exports is another factor that has contributed to Vietnam’s economic growth. With its successful integration into the global supply chain, the country has become a major producer of goods such as clothing, electronics, and footwear. Since then, Vietnam has witnessed a steady increase in exports and is now one of the world’s leading exporters.

It is also an attractive destination for foreign investment as a result of Vietnam’s growing economy. Due to the country’s large and growing market, favorable policy environment, and relatively low labor costs, this trend has been able to flourish. This has led to the establishment of many multinational companies in Vietnam, as well as the development of a hub for foreign investment in Southeast Asia.

As well as its growing exports, Vietnam’s economy is also driven by its expanding domestic market. It is the country’s large and growing middle class that is driving demand for goods and services. It is also helping to propel growth in sectors such as consumer goods, retail, and tourism.

Finally, Vietnam focuses on innovation and technology as a means of driving economic growth. As part of its efforts to build a thriving ecosystem for startups and innovative businesses, the government is investing in research and development. Vietnam’s focus on technology and innovation is creating new jobs and positioning the country as a regional leader.

Overall, Vietnam’s growing economy demonstrates the country’s resilience and determination. From its humble beginnings as an agrarian nation, Vietnam has risen to become one of the world’s leading centers for industry, trade, and innovation. Vietnam’s economy looks bright in the future due to a favorable policy environment, a growing export market, and a focus on innovation and technology.

Become a part of the fastest-growing economy in Southeast Asia by expanding your business in Vietnam. With our Company Set-up services, Express Vietnam strives to provide you with assistance in launching a successful business from the very beginning. Let us help you set up your new company today.