Researching the needs, trends and potentials of the healthcare sector in general and of each product line in specific is the crucial first step for any pioneering medical device manufacturer.Vietnam market with a total population of more than 90 million and with increasingly diversified and specialized medicare needs is always amongst prioritized countries to invest, as compared to other South-East Asian ones. READ MORE

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. READ MORE

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. READ MORE 

During the procedures of applying for marketing authorization code of medical devices, beside the documents approved by the Vietnamese Ministry of Health to use in English, most of them must be translated into Vietnamese. Documents such as catalogs, instructions for use and technical documents of medical device cannot be translated by using online translation tools or regular language translators. Thousands of medical terms can only be translated by medical engineers and experts so that they can be used in the marketing and sales process. In addition, technical documents will be subject to the provision of the AMDD. READ MORE 

Whilst carrying out circulation registration procedures for high-risk imported medical equipment, the Ministry of Health requires the compilation of clinical evaluation reports in accordance with regulations in Vietnamese. Tons of medical terminology can only be compiled by medical engineers and professionals in order to be used in marketing and sales processes. READ MORE

In case the medical device manufacturers require more time to strike into the Vietnamese market, the administrative fees during market exploration and market demand assessment will reduce remarkablely if you choose to use Mednovum’s In-Country Representative service. On behalf of ourselves, we will collect the product’s legal dossiers and register to Vietnamese Ministry of Health. We will be the legally responsible unit for the product during circulation in Vietnam. READ MORE

Since 2017 and expected to the end of 2022, Vietnam marketing authorization registration procedure will be fully compatible with the ASEAN Agreement. Depending on the risk classification, import or domestic status, and timing of circulation of each product line, Mednovum will advise clients on the procedures for applying for a marketing authorization number or for an import license, or both.The marketing authorization number or import license is the prerequisites for importing medical devices  into Vietnam and selling those products to the market. The marketing authorization registration procedure usually lasts from months to a year, depending on the level of backlog of the Ministry of Health from time to time. With careful and professional service, we are committed to providing the optimal pathway and expected results. READ MORE

Investment license:For large-scale manufacturers are likely to establish companies in Vietnam to trade and/or manufacture medical devices. With Mednovum and our partners LexNovum Investment Lawyers, we are fully capable to deliver those specialized requirements.Land rental service:With MedNovum, our consultants understand well about the industrial real estate market, project availability, project compatibility and each site’s emissions requirements. Thereby, we will always provide accurate orientational reports in accordance with the investor’s budget to find a suitable location.Setup HR/ Labor hire servicePartnering with Mednovum in Vietnam, there are also a robust team of HR experts with many years of experience in developing manpower resources, hiring and training suitable personnel for highly demanding professions such as manufacturing and selling medical device. Wait no more! Reach out to us to build a reliable team of local experts, even a qualified local director, combined with experts from Canada to commence sales, importing and exporting. READ MORE

You are a manufacturer in Vietnam wishing to bring your medical devices to the North American market?Let’s start with registration in Canada, which is considered as the gateway to the North American market and where the legal procedures are almost similar to those in the United States. However, the time and procedures in Canada will be carried out shorter and far less expensive.With our permanent office in Ontario, Canada, and along with the support and cooperation of local licensed partners, Mednovum Canada will provide market research service, assessment services and guideline of North American requirements for R&D projects and client’s business outreach.

Understanding the difficulties of Vietnamese manufacturers in terms of geography, cost, language barrier and business conditions in accessing the North American/Canadian market, the team of Ontario-based experts will support you with useful information, marketing registration, product performance testing/assessing, quality management process assessment and other procedures for marketing purposes in Canada.

Medical device is classified according to the level of risk to human health. In Canada, medical device is classified into 4 groups according to increasing risk level: group I, II, III and IV. Corresponding to the classification results of medical device, there will be different regulations. With Mednovum Canada, we can provide you with accurate services at competitive pricing.

Technical document is important documents for the relevant authorities to classify and evaluate the conformity of medical device against diagnostic and therapeutic standards. Therefore, Mednovum’s specialists will carefully review this documentation before issuing a circulation license to the market.

A clinical evaluation report is a scientific document, written based on product tests at accredited laboratories and clinical trial results at accredited medical facilities. Clinical trials are to determine the effectiveness of the product, whether it meets the standards and safety level. The Canadian professional authorities will read and evaluate whether this report meets the regulatory standards or not.This is an intricate and complex document that requires a team of experienced experts to compile.

We will act on behalf of Vietnamese clients to complete the product registration process and appoint a representative to hold the marketing authorization number in Canada for the clients through legal and licensed partners of the local government.

We will summarize and review the dossiers according to the circulation regulations of medical device and proceed to submit the application to the Canadian competent authorities. Besides, MedNovum will always accompany the clients until the medical device is licensed for circulation.

Support and represent clients in the process of working with local / federal authorities in recalling or warranty activities for medical devices that have been circulated in Canada.