COMMITMENT
We are committed to providing professional, accurate and dedicated services based on our rich expertise in the regulatory requirements of medical devices.
PROFESSIONAL
We know that a good consultant makes all the difference to our clients' satisfaction and success. Our team is well-integrated and includes experts in many fields, especially medical devices, law, business consulting and business operations.
QUALITY
With customer-centricity in mind, we continuously improve our service quality until customers are completely satisfied with MedNovum's delivery.
ABOUT US
MedNovum's vision is to become a trusted partner, a bridge connecting manufacturers from North American and Europe with the potential Asian market in creating superior values in the field of medical devices, providing solutions for compliance and sustainable development.
At MedNovum, we provide comprehensive services in licensing management and legal representation (MAH/License Holder) for international medical device manufacturers seeking to expand into Asian markets. Our services range from in-depth consulting on market access, regulatory compliance, and risk management to supporting the establishment of local businesses or legal entities.
We continuously enhance our service quality and customer experience, helping businesses bring their international brands and products to Asian markets quickly, safely, and in full compliance.
MedNovum has a team of lawyers, doctors, lecturers and experts in the field of medical devices, who have many years of experience in the registration, import and post-inspection of medical products. The combination of professional knowledge and regional legal understanding makes us your trusted partner in the Asian market.
“MedNovum – Seamless services by Experts"
OUR SERVICES
Medical equipment
Client
Project
Years of experience
OUR CUSTOMERS
OUR TEAM
CUSTOMER QUESTIONS
CE Marking certification means certifying that the product is suitable and meets the requirements of the European market. However, CE Certification is currently issued by a non-governmental organization, not a document of a competent authority of any country, so it has not been recognized by the Vietnamese Ministry of Health.
Documents as prescribed must be consular legalized. If submitting a copy of a consular legalized copy, the copy must have a certified true copy stamp.
If the document is not written in English, it must be accompanied by a Vietnamese translation and the translation must also be certified.
During the initial phase of applying Decree 36 to import Class A medical equipment, we received feedback from a number of enterprises that the Customs Sub-Departments of some provinces/cities refused to accept the printed electronic version of the foreign competent authority containing information on the classification of medical equipment when carrying out customs clearance procedures. The reason given was that Circular 42/2016 only applies to the preparation of dossiers for declaring applicable standards or requesting circulation numbers, not to customs clearance procedures because it is not consistent with the regulations on the format of customs documents. To resolve the differences in application, the Ministry of Health sent Official Letter No. 3593/BYT-TB-CT dated June 23, 2017 to the General Department of Customs to confirm that the provisions of Circular 42/2016 also apply to cases where enterprises carry out customs procedures for import. Please click here to download Official Letter 3593.
Are you a manufacturer in Vietnam looking to bring your medical devices to the North American market? Start by registering in Canada, which is considered the gateway to the North American market and has almost the same regulatory procedures as in the United States. However, the time and procedures in Canada will be shorter and less expensive. A guide to North American requirements for R&D projects and customer business access.
According to the provisions of Article 7 of Decree 36/2016, any enterprise that has a person performing the classification of medical equipment that meets the legal conditions can self-publish the results of the classification of medical equipment for itself. It should be noted that before self-classification, the enterprise must complete the procedure for declaring eligibility to classify medical equipment on the Online Public Service System for Medical Equipment Management of the Ministry of Health and only perform the classification after the Ministry of Health has issued a receipt for the declaration dossier.
The classification results for medical equipment are valid for the entire life cycle of the product, unless the Ministry of Health concludes to cancel its validity. Current regulations do not have any provisions specifying the case of canceling the classification results for medical equipment at the request of the personnel in charge of the classification.
However, when the personnel in charge of classification ceases to work, your Company is considered no longer qualified to perform the classification of medical equipment. Your Company can only continue to perform the classification after recruiting new suitable personnel and completing the procedure for declaring eligibility to reclassify medical equipment.
LEGAL BASIS
Legal documents
- Decree 07/2023/ND-CP amending and supplementing a number of articles of Decree 98/2021/ND-CP on medical equipment management
- Draft February 2023 amending and supplementing a number of articles of Decree 98/2021/ND-CP on management of medical equipment
- Circular 06/2022/TT-BYT regulating the list and issuance of circulation numbers for medical equipment serving COVID-19 prevention and control in urgent cases
- CIRCULAR 05/2022/TT-BYT DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF DECREE NO. 98/2021/ND-CP DATED NOVEMBER 8, 2021 OF THE GOVERNMENT ON MANAGEMENT OF MEDICAL EQUIPMENT
- Decree 98/2021/ND-CP on medical equipment management
- Consolidated Document 01/VBHN-BYT March 16, 2020 Consolidating Decree on Medical Equipment Management Issued by the Ministry of Health
- Decree 03/2020/ND-CP dated January 1, 2020 Amending Article 68 of Decree 36/2016/ND-CP on Medical Equipment Management Amended by Decree 169/2018/ND-CP Amending Decree 36/2016/ND-CP on Medical Equipment Management
- Circular 13/2021/TT-BYT Regulating the issuance of circulation numbers and import of medical equipment for COVID-19 prevention and control in urgent cases
- Circular 43/2021/TT-BTC AMENDING AND SUPPLEMENTING CLAUSE 11 ARTICLE 10 CIRCULAR NO. 219/2013/TT-BTC
- Draft: DECREE Amending and supplementing Article 68 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP on medical equipment management
Executive directive document
- Decision No. 1661/QD-TTg: Approving the Plan to Reduce and Simplify Regulations Related to Business Activities Under the Management Scope of the Ministry of Health
- Official dispatch No. 15/BYT-TB-CT: Regarding the implementation of Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on medical equipment
- Official dispatch No. 14/BYT-TB-CT: Regarding the implementation of Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on Management of medical equipment
- OFFICIAL DISPATCH NO. 7165/BYT-TB-CT – Regarding the implementation of Resolution No. 131/NQ-CP dated December 6, 2017 of the Government.
- OFFICIAL DISPATCH NO. 7370/BYT-TB-CT – Regarding the implementation of Resolution No. 131/NQ-CP dated December 6, 2017 of the Government.
- OFFICIAL DISPATCH NO. 7371/BYT-TB-CT – Regarding the implementation of Resolution No. 131/NQ-CP dated December 6, 2017 of the Government
- RESOLUTION NO. 131/NQ-CP – On implementing the contents of Resolution No. 131/NQ-CP dated December 6, 2017 on granting circulation registration numbers for medical equipment B, C, D.
- OFFICIAL DISPATCH NO. 1879/BYT-TB-CT – Regarding thematic report on imported medical equipment for in vitro diagnosis
- OFFICIAL DISPATCH NO. 4196/BYT-TB-CT – Regarding adjusting the validity of medical equipment import licenses.
- OFFICIAL DISPATCH 3593/BYT-TB-CT – Coordinating guidance on implementing regulations in Decree 36/2016/ND-CP
Notification
- MedNovum is awarded ISO 9001:2015 Quality Management System Certificate
- Summary of draft content Regarding Summary of draft content on reduction, amendment and supplementation of regulations in Decree 36/2016/ND-CP
- Appendix to the new Decree on Essential principles on safety and technical features of medical equipment
- Official dispatch on Comments on Draft Decree amending conditions related to investment and business conditions of medical equipment
- Draft decree on business conditions in the field of medical equipment - Re: Amending regulations related to business conditions in the field of medical equipment.
- OFFICIAL DISPATCH NO. 3949 BYT-TB-CT – Regarding troubleshooting problems in granting import licenses for medical equipment to implement the National Single Window Mechanism.