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Regulatory affairs services of medical devices

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COMMITMENT

We commit to provide professional, accurate and dedicated services based on rich expertise of medical device regulatory requirements.

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PROFESSIONAL

We know that a good consultant makes all significant differences to clients’ satisfaction and successes. Amazingly fused, our team comprises of experts across multiple fields, particularly medical devices, law, business consulting and business operation.

ENTHUSIASM

SATISFACTION

With customers at our hearts, we are constantly improving serving quality until our client is completely pleased with MedNovum’s delivery.

ABOUT US

MedNovum’s vision is to become a trustworthy partner among Vietnam, Canada and the world in conceiving outstanding joint values in medical device field.

At MedNovum, we are unceasingly ready to provide customers with all-inclusive services from in-depth market access consulting, legal regulation, risk management to new business setup in Vietnam. We persistently upgrade our services and customer experiences to fulfill your business opportunities and bring your brands and products to Vietnam and Canada.

MedNovum employs a team of lawyers, doctors, master-degree holders and lecturers working in hospitals and medical universities, who possess many years of consulting experience in importing, publishing and registering medical devices. We are confident to be your credible partner in the highly potential Vietnam market.

MedNovum – Seamless services by Experts

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SERVICES OF MEDNOVUM

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579

Medical Devices

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248

Clients

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Investment Projects

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Years of experience

OUR CLIENTS

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THE FIRST CIRCULATION PROCEDURE CONSULTING TOOL IN VIETNAM

CUSTOMERS' QUESTIONS

CE Marking Certificate is a certification mark that indicates conformity with the qualities within the European Economic Area (EEA). However, the current CE Marking Certificate is issued by a non-governmental organization, it is not the document of competent authority of any country. Therefore, it is not admitted yet by Vietnam’s Ministry of Health.

Prescribed documents must be consular legalized. If the copies of documents which were consular legalized are submitted, these copies must be stamped as the notarized copies of the original.

If such documents  are not in English, it must be accompanied with  authenticated Vietnamese translations.

During the first stage of applying the Decree No. 36 on importing medical devices Class A, we received  feedbacks from some enterprises that the  Department of Customs of border gate of some provinces/cities refused to accept printed copies of website of foreign competent authorities  which contained classification information of medical devices when carrying out customs clearance procedures. The reason is that Circular No. 42/2016 is only applied for compiling dossiers for applicable standards declaration or granting marketing authorization codes , but not to apply  for the customs clearance procedures because of non-compliance with the regulations on the document format of customs documents. To solve the differences in practicing, the Ministry of Health has sent Official Letter No. 3593/BYT-TB-CT dated June 23, 2017 to the General Department of Vietnam Customs  to confirm that the provisions of Circular No. 42/2016 can also be applied to cases where enterprises carry out customs procedures for importing. Please click here to download Official Letter No. 3593.

Prescribed documents must be consular legalized. If the copies of documents which were consular legalized are submitted, these copies must be stamped as the notarized copies of the original.

If such documents  are not in English, it must be accompanied with  authenticated Vietnamese translations.

By laws, the medical device classification result is valid until the end of the product life even though the marketing authorisation number is terminated. For Class B, C or D medical device, the marketing authorisation number is valid for 5 years only, but when doing the re-registration process, you can still use the old classification result.

It should be noted, however, that if a medical device’s indication is changed, you should re-classify said product. For example: the blade and stapler that is used in laparoscopic procedure. In the re-registration process, when the indication is expanded for use in cardiac surgery or thoracic procedures, the product should be re-classified.

Pursuant to dossiers on marketing authorization number to Class A medical device published in portal of the Ministry of Health, we collected a list of some classification service providers as below:

  • College of Medical Device Technicque – the Ministry of Health;
  • H and X Medical Equipment Materials Joint Stock Company
  • National Institute of Medical device and Construction – the Ministry of Health;
  • MEDNOVUM MEDICAL TRADING AND SERVICE COMPANY LIMITE

LEGAL GROUNDS