Since 2016, the Vietnamese government has begun implementing harmonized regulations for the management of medical devices in line with the ASEAN regional standards and those of developed countries. Accordingly, low-risk medical devices, classified as Class A, is allowed by the Ministry of Health to undergo the standard application procedure for circulation without prior review or licensing from local health authorities. As a consequence, registration lead time for Class A is about 7 -10 days. Since 2022, a similar process was extended to the group of higher-risk medical devices, classified as Class B. However, after several years of experimentation, the market has witnessed numerous deliberate violations, with the main errors being:
Misclassification: Intentionally misclassifying devices to lower the risk classification from Class C or D to Class A or B in order to apply the Declaration procedure.
Incomplete or inaccurate documentation: Providing or posting incomplete, incorrect, or expired documentation to obtain Marketing Authorisation Code (MAC).
Applying Class A/B Medical Device registration procedures to products belonging to cosmetic, pharmaceutical, dietary supplement to illegally cut short the registration procedure.
Applying Class A/B Medical Device registration procedures to general merchandise groups to illegally reduce VAT or import tax.
These violations have highlighted the need for stricter enforcement and monitoring of medical device regulations to ensure the safety and effectiveness of these products in the Vietnamese market. The government and relevant authorities are taking steps to address these issues and enhance compliance measures to protect public health and maintain the integrity of the medical device industry.
Furthermore, the violations mentioned above may occur outside the control or awareness of the manufacturer, as registration is granted to domestic importers. This outdated approach not only creates an implicit monopoly for importing entities but also poses potential legal compliance risks for manufacturers. In recent years, many manufacturers based outside Vietnam have turned to MedNovum to utilize our legal representation service, which we call Marketing Authorisation Holder (MAH). As a non-trading legal representative, MedNovum has brought significant benefits to our clients in various countries, including:
Understanding local legislation: With a team guided by lawyer Nguyen Trung Hieu, who has nearly 10 years of experience in regulatory affairs for medical devices, MedNovum can provide detailed specialized guidance tailored to each product line.
Professional services: Trusted by customers from multiple countries, MedNovum continually improves to standardize services and provide assistance to ensure customer satisfaction and peace of mind when entering the Vietnamese market.
One-Stop services: MedNovum confidently offers various services for product registration in Vietnam, with a team of legal, technical, translation, and medical experts.
Easy accessibility: In addition to our main office in Ho Chi Minh City, Vietnam, as of 2021, MedNovum has established an office in Toronto, Ontario, Canada, to facilitate contact and provide consultation to customers from North America.
Contact us today for a prompt response regarding the legal procedures to pave the way for your product to access the vibrant market of 100 million people in the Southeast Asia region.