Regulatory Pathway

Regulatory Pathway

Once deciding to enter into the Vietnamese market, medical device manufacturers and investors need  to fully understand that every step must be carefully planned at highest legal compliance standards of the local country. Vietnamese law has many different regulations governing trade and investment activities on medical devices, such as regulations governing factory construction, factory standards to comply with ISO 13485:2016 or numerous standards to legally produce medical devices in Vietnam. Furthermore, depending on the risk level of a medical device, the regulations would be varied and require strong experts to guide you through.

MedNovum, in collaboration with LexNovum (a Law Firm belong to our ecosystem), will provide clients with a complete consulting report about all relevant legal regulations, product circulation pathway or licensing guideline to open a medical device factory.

We are confident that we understand better than anyone else in Vietnam the unique regulatory requirements for medical device and the preferential policies for each product line so that we can advise our clients on the optimal solutions.

Our Legal compliance report will be based on the business needs of each specific group of medical device; nevertheless, it includes the following primary contents:

  1. Risk classification of the product line to be manufactured;
  2. Compliance requirements of the health sector for each specific product group for circulation in Vietnam or for exporting purpose;

Besides, if the client wants to build factories in Vietnam, there will be more items as following:

  1. Analysis of advantages and disadvantages if investing in industrial parks versus export processing zones.
  2. Procedure for registration of building a factory in an industrial park/ export processing zone;
  3. Procedures of applying for land lease and getting a certificate of land use right;
  4. Procedures of DTM assessment, ISO 13485:2016 assessment and other ISO Certificates specifically required for medical device manufacturing;
  5. Procedure of declaration of eligibility to produce medical device;
  6. Procedure of applying for a factory construction permit;
  7. Procedures of proclaiming applicable standards and marketing authorization code for medical devices which are manufactured in Vietnam; and
  8. Procedure of applying for CFS towards medical devices with the purpose of exporting.

You need to consult, receive price quotation. Please contact us immediately via hotline. Consultants will give you the best service.

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