Are you looking to expand your medical device business into Vietnam but still wonder how to export medical devices to Vietnam? Attracting local buyers at international exhibitions is a huge win, but navigating Vietnam’s complex medical regulations can take 6 to 12 months. Without a local legal entity, you risk losing sales to already-licensed competitors.
And appointing an independent Local Authorized Representative (AR) is the fastest, safest way to enter the market and connect with over 1,000 active local distributors.
I. Key challenges of Exporting to Vietnamese Market
Complex & Time-Consuming Import Procedures: Navigating Vietnam’s strict medical device regulations requires deep local expertise. Trying to figure it out on your own causes massive delays and extends your time-to-market.
No Local Entity: Foreign manufacturers are legally barred from directly holding a Marketing Authorization (MA) registration number in Vietnam without establishing a costly local subsidiary or representative office.
Inefficient Distributor-Led Licensing: If you rely on local importers to hold your licenses, each importer must apply for their own individual permit for your products. This forces you to wait months for every new partner to get cleared, heavily restricting your market agility.
II. The 3-Step Go-to-Market Process
Step 1: Manufacturer appoints an commercial representative in Vietnam that is authorized as Marketing Authorisation Holder in this country.
Step 2: Carrying out registration procedures to the competent authority in Vietnam: medical devices classification, import license and declaration of applied standards/registration number for medical devices.
Step 3: Promotion and distribution of medical devices into Vietnam.
III. Why you should choose Airseaglobal Group as your Marketing Authorisation Holder?
Widely recognized as the "King of Medical Device Import Services" in Vietnam, we don’t just process paperwork—we unlock the entire market for your brand:
- One-Time Licensing, Unlimited Distribution: By holding your MA license independently, we ensure you only need to complete the registration process once. After that, you can authorize any local importer or distributor to import your products instantly without waiting for new permits.
- Instant Network (1,000+ Distributors): We manage the largest B2B medical equipment communities in Vietnam (20+ active Zalo and Facebook groups) to actively promote your brand.
- Proven Track Record: Trusted by hundreds of international medical and dental brands worldwide.
- Robust Local Presence: A dedicated team of nearly 50 regulatory and logistics experts operating across Hanoi, Ho Chi Minh City, Hai Phong, and Da Nang.
IV. Some brands we are Authorized License Holder
Ready to Streamline Your Market Entry?
Get your medical devices certified, cleared through customs, and distributed to the right partners without the administrative headaches. Contact us today for a free consultation within 24 hours.
- Wechat / Zalo / WhatsApp / Viber: +84 379864016 (Ms. Vy)
- Email: vyntt@airseaglobalgroup.com.vn
- Head Office: 8th Floor, Phu Minh Building, 82 Tran Thai Tong St, Cau Giay Ward, Hanoi, Vietnam.
- Website: thutucnhapkhauthietbiyte.com.vn
