Established in 1945, the Ministry of Health (MoH) in Vietnam is a government agency tasked with overseeing and managing various aspects of public health and healthcare products. This includes pharmaceuticals, medical devices, preventive medicine, medical care and treatment, rehabilitation, traditional medicine, food safety, nutrition, and hygiene. Additionally, it oversees a network of public hospitals, educational institutions, and research centers.
2. Vietnam’s MoH medical device registration
More than 90% of medical supplies and equipment are brought into Vietnam from overseas. As reported by Fitch Solutions, forecasts indicate that the sector is expected to experience a Compound Annual Growth Rate (CAGR) of 9.5% between 2022 and 2027. The most commonly imported and utilized medical equipment are consumables, cardio stents, dental items, diagnostic imaging, and orthopedic and prosthetic devices.
Medical devices in Vietnam fall into 4 main categories – Type A, B, C, and D – each associated with different levels of risk.
For Type A and B devices, which have low to low-moderate risk, the registration applicant must submit a declaration application to the Department of Health (DOH) via the online portal of IMDA at https://dmec.moh.gov.vn. Once the DOH receives sufficient and satisfactory documents, it publishes the applied standards for these devices on the medical device management portal, and local authorities apply a post-market audit mechanism.
Type C and D devices, which pose moderate-high to high risks, also require registration applications to be submitted to the IMDA through the same online portal. However, for these Class C and D products, after receiving an application, the MOH issues a notice of receipt. If the application meets the criteria, the MOH processes it within 30 days. However, if the application is unsatisfactory, the MOH requests modifications within 25 days of receipt. The applicant must comply with these requests. If the modified application remains unsatisfactory after multiple attempts, or if the applicant fails to provide the necessary modifications within 90 days, the application is rejected. Post-market inspections are also implemented to ensure the quality of imported and circulated medical devices in Vietnam.
3. Vietnam’s MoH pharmaceutical registration
The Drug Administration of Vietnam (DAV), a decentralized body under the Ministry of Health (MOH), oversees the drug approval process in Vietnam. All pharmaceutical products must be approved by the DAV, and imported items require an ‘Import Permit’.
Drugs in Vietnam fall into different legal classifications:
- Over-the-Counter (OTC) Drugs: These can be sold directly to consumers without a prescription and are safe for self-medication.
- Prescription Drugs: These can only be obtained with a prescription from an authorized healthcare professional, requiring closer monitoring.
- Traditional Herbal Medicines: Vietnam has a tradition of herbal remedies, some of which are regulated by the Ministry of Health and used alongside modern pharmaceuticals.
- Controlled Drugs: These substances carry a higher risk of abuse or harm to public health. Examples include certain opioids, stimulants, sedatives, and psychoactive substances.
The Ministry of Health (MOH) assesses and provides authorization for all medications intended for use in clinical trials, encompassing Phases I through IV, unless such drugs are deemed exempt by the regulatory agency. Furthermore, these medications must have gained approval from either a Science and Technology Council or a specialized Ethics Committee in the specific field of medicine, confirming their efficacy and safety for the treatment of traditional medical conditions.
Required documents for registration of pharmaceutical products are outlined below.
– Submission of the application for registration.
– Authorization letter.
– Certificate of operating in medicine and medicine raw materials in Vietnam.
– Certificate of Eligibility for pharmacy business.
– License for pharmaceutical establishment of a representative office in Vietnam.
– Certificate of Pharmaceutical Product (CPP) or FSC Certificate if the foreign medicine company does not have CPP.
– GMP and GLP compliance certificates.
– Comprehensive information about drug substances and products, including general details and composition.
– Labeling materials.
Within 12 months from the application submission, the DAV will evaluate the registration dossier and forward it to the Advisory Council for the issuance of a drug registration certificate.
The drug license’s validity is maintained through an online system, with the drug’s validity published online. Typically, a drug license is granted for 12 months, after which continued validity of the old license is contingent upon a successful reevaluation.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.trade.gov/market-intelligence/vietnam-medical-device-registration-0