COMMITMENT
We commit to provide professional, accurate and dedicated services based on rich expertise of medical device regulatory requirements.
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.
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”
SERVICES OF MEDNOVUM
Medical Devices
Clients
Investment Projects
Years of experience
OUR CLIENTS
OUR TEAM
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
Legal Documents
- Decree 98/2021/ND-CP: Prescribing medical device management
- Decree No 01/VBHN-BYT On Management Of Medical Devices
- Decree No. 03/2020/ND-CP 01/01/2020 Amending Article 68 Of Government’S Decree No. 36/2016/Nd-Cp Dated 15/05/2016 On Medical Device Management Amended By Government’S Decree No. 169/2018/Nd-Cp 31/12/2018
- DECREE No. 169/2018/ND-CP: AMENDMENTS TO THE GOVERNMENT’S DECREE NO. 36/2016/ND-CP DATED MAY 15, 2016 ON MEDICAL DEVICE MANAGEMENT
- CIRCULAR 46/2017/TT-BYT – GUIDELINES FOR THE GOVERNMENT’S DECREE NO. 36/2016/ND-CP DATED MAY 15, 2016 ON MANAGEMENT OF MEDICAL EQUIPMENT
- DECREE 36/2016/NĐ-CP – ON MEDICAL EQUIPMENT MANAGEMENT
- CIRCULAR 30/2015/TT-BYT – ON IMPORT OF MEDICAL EQUIPMENT
- CIRCULAR 39/2016/TT-BYT: CLASSIFICATION OF MEDICAL DEVICES
- CIRCULAR 14/2018/TT-BYT – PROMULGATING THE NOMENCLATURE OF MEDICAL EQUIPMENT WHOSE HS CODES HAVE BEEN ASSIGNED IN THE VIETNAM’S NOMENCLATURE OF EXPORTS AND IMPORTS
- Circular 278/2016/TT-BTC – PROVIDING FOR FEES IN MEDICAL SECTOR, AND THE COLLECTION, TRANSFER, MANAGEMENT AND USE THEREOF
Executive Documents
- Official Letter No. 7165/BYT-TB-CT regarding the implementation of the contents of Resolution No.131/NQ-CP issued by the Government on 06 December 2017
- Official Letter No. 7370/BYT-TB-CT regarding the implementation of the contents of Resolution No. 131/NQ-CP issued by the Government on 06 December 2017.
- Official Letter No. 7371/BYT-TB-CT regarding the implementation of the contents of Resolution No. 131/NQ-CP issued by the Government on 06 December 2017.
- Resolution No. 131/NQ-CP regarding the implementation of contents of the Resolution No. 131/NQ-CP issued on 06 December 2017 on issuing marketing authorization codes towards medical equipment Class B, C and D.
- Official Letter No. 4196/BYT-TB-CT regarding adjust the validity of import licenses for medical equipment.
- Official Letter No. 9139/BYT-TB-CT which is sent to enterprises on the implementation of online public services on the implementation of Decree No. 36/2016/ND-CP issued by the Government on 15 May 2016 on management of medical devices.
- Document No. 5278/BYT-TB-CT regarding the free sale registration of medical devices Class B, C and D according to Decree No. 36/2016/ND-CP issued by the Government.
Declarations
- Mednovum achieved ISO 9001:2015 quality certification for management system
- Summary regarding the reduction, amendment and supplementation of Decree No. 36/2016/ND-CP.
- Appendix of the new Decree regarding the essential principles of safety and technical features of medical devices
- Official Letter regarding the comment on Draft Decree relating to the investment conditions in medical devices business
- Draft Degree on the conditions of trading in medical devices sector regarding the amendment of regulations related to medical devices business conditions.
- Official Letter No. 3949/BYT-TB-CT regarding the troubleshoot of granting medical devices import licenses when implementing the National one-door mechanism.