Medical Devices Business Regulations Modified in Vietnam

Jan 2019

The Vietnam Ministry of Health (MOH) issued Decree No. 169/2018/ND-CP on 31 December, 2018 amending and supplementing some articles of Decree No.36 on Medical Device Management. The changes, which have taken effect on January 01, 2019, affect the below:

• Explanation of the definition of Medical device;
• Classification of Medical device;
• Conditions of establishments that classify, produce and trade Medical device;
• Procedures for declaration, registration for circulation and importation of Medical device;
• Activities of inspection and calibration of device;
• Management and use of Medical device in Medical facilities;
• Organization of implementation.

Decree 36 has been reported by foreign and local industry associations to cause some difficulties for business activities, including overlapping regulations and cumbersome administrative procedures, costing time and money for businesses and other stakeholders. Decree 169 aims to fix the faults and simplify business conditions for enterprises operating in the market.

(Source: Department of Medical Equipment and Construction)

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Orissa International helps companies that want to develop a market entry strategy for Southeast Asia or implement their business expansion into the region. We have very strong domain knowledge of markets and industry sectors, and a business network of over 16,000 companies that includes distributors, resellers, system integrators and local manufacturers, that we have built through advising and guiding more than 5,000 companies with their market expansion into the ASEAN region over the last 25 years.

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