After the participation of Vietnam in the ASEAN Agreement on Management of Medical Device (AMDD), relevant Vietnamese legal regulations have been established to be compatible with specific regulations for each product group and its risk classification.
Despite the fact that general risk classification rules in developed countries are recognized and applied, the Ministry of Health of Vietnam also has its own guidelines and viewpoints about risk classification of medical device in accordance with the domestic management conditions and usage. Therefore, the risk classification results of medical devices in Vietnam are not always similar that in Europe or the USA.
Hence, in Vietnam, only experts who have been duly appraised and licensed by entities that have obtained the declaration of eligibility to classify medical device, such as MedNovum, are allowed to provide this special service, which serves as the foundation to import and registrate for circulation in Vietnam.
With a team comprised of highly qualified engineers and pharmacists, those who have extensive experience in the field of medical device risk classification, and experienced lawyers, MedNovum is always proud to be among the biggest service providers in Vietnam. Our clients in medical device sector greatly varies from world’s leading manufacturers to new market entrances.
Therefore, MedNovum is confident to:
- Explain and clearly state the list of required documentation for the classification of each product/ model in only one consultation;
- Thoroughly review the provided documents and provide detailed instructions if the requirements are not met;
- Classify and return results together with preliminary instructions for registration, which always ensure the best compliance while saving time for clients ;
- File classification results and publish them on the official website of the Ministry of Health of Vietnam for easy access during customs clearance or circulation registration.
With MedNovum, each of our risk classifications is furnished with professional liability insurance provided by the PVI Insurance to secure any risk that the client may face due to our mistake.
So, contact us right now for the all-inclusive risk classification service!
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