LOCAL AUTHORIZED REPRESENTATIVE SERVICES IN VIETNAM

Distribution Process for Medical Devices for Companies without a Representative Office in Vietnam

Step 1: The manufacturer needs to select an authorized commercial representative in Vietnam that meets legal requirements and has experience in the medical devices field to register the circulation number.

Step 2: The authorized representative in Vietnam must:

– On behalf of the company in all procedures with the regulatory authority responsible for medical devices and in-vitro diagnostics, including:

• Registering your product
• Obtaining import licenses 
• Submitting change notifications
• Ensuring post-marketing surveillance once your product is authorized and placed in the market, including adverse events and product recalls.

– Ensure compliance assessments are carried out, if required.

– Ensure medical devices or IVDs are labeled, and the information on labels is provided in the specified national language.

– Serve as the contact between the manufacturer and the relevant authorities in Vietnam.

– Assist in resolving complaints.

– Monitor regulations to update the manufacturer on any changes or new regulations applicable to their products.

Step 3: Collaborate with distribution partners, authorize the manufacturer’s distributor for the import and circulation of medical devices in the Vietnamese market, and promote the market through exhibitions and events to introduce products and enhance brand name awareness.

This process requires precision and accuracy to ensure that medical devices are distributed legally and safely in the Vietnamese market.

Medgate – Pioneering Local Authorized Representative Service in Vietnam

We take responsibility for and engage with state agencies on the following activities:

– Implement the medical device classification process.

– Declare standards for Class A and B medical devices and register circulation numbers for Class C and D devices as per regulatory requirements.

– Ensure continuous compliance while holding the circulation number and be responsible for submitting updated documentation in case of legal changes in Vietnam to ensure business continuity.

– Support market access by connecting manufacturers with potential importers and distributors through our network in Vietnam.

– Assist information exchange between manufacturers and designated distributors in Vietnam.

– Monitor the situation after the authorized medical device is introduced to the Vietnamese market.

Medgate commits to ensuring all processes and related activities strictly comply with regulations, simultaneously providing comprehensive support to its partners in the Vietnamese market.

Why Should Choose Medgate as the in-country Representative  in Vietnam

– Professional Services: Our experienced team in the field of medical devices commits to compliance with Vietnamese laws. We not only provide services but also offer in-depth legal advice to help clients understand and fully comply with relevant regulations.

– Cost Savings: Eliminate the costs of establishing a representative office, searching for, and managing a workforce in Vietnam.

– Time Savings

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.