Your Strategic Gateway to a Compliant Market Entry
Vietnam’s healthcare sector is undergoing rapid modernization, leading to a soaring demand for advanced medical devices, diagnostic equipment, and innovative medical supplies. However, strict government oversight and frequently updated decrees by the Ministry of Health (MOH) make market entry highly complex for international manufacturers.
At Sumpharma, we clear the path for your technologies. We provide comprehensive, end-to-end medical device importation, regulatory affairs (RA), and localization services, ensuring your products enter the Vietnamese healthcare market with absolute legal compliance and efficiency.
Our Comprehensive Medical Device Solutions
We manage the entire regulatory and logistical lifecycle of your medical devices, strictly adhering to Decree 98/2021/ND-CP and the latest Vietnamese healthcare circulars. Our core capabilities include:
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Risk Classification & Consultation: Accurately determining and verifying the risk classification of your devices (Class A, B, C, or D) based on Vietnamese regulations and ASEAN Medical Device Directives (AMDD).
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Registration & Licensing (MA/Registration Numbers): Preparing, building, and submitting technical dossiers to secure Marketing Authorization (MA) Licenses (Số lưu hành thiết bị y tế) or Import Licenses from the Ministry of Health.
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Local Representative / License Holder Services: Acting as your trusted local legal representative in Vietnam, legally authorized to hold your product registrations while strictly safeguarding your proprietary technical data.
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Customs Clearance & Specialized Inspection: Managing specialized customs clearance, import tax optimizations, and strict border inspection procedures tailored for medical and diagnostic commodities.
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GDP-Compliant Logistics: Storing and transporting sensitive medical goods in temperature-controlled, strictly monitored environments that meet Good Distribution Practices (GDP) requirements.
Technical Documentation Support
The technical dossier (CSDT – Common Submission Dossier Template) required by the Vietnamese MOH is highly rigorous. We work hand-in-hand with your global RA teams to organize and optimize crucial documentation, including:
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ISO 13485 Certification: Verification of valid Quality Management Systems.
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Certificate of Free Sale (CFS): Ensuring proper format and required consular legalization.
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Letter of Authorization (LOA): Standardized templates to legally appoint Sumpharma as the registration applicant.
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Instruction for Use (IFU) & Technical Summaries: Translating and adapting medical instructions into Vietnamese compliant-ready formats.
Why Partner with Sumpharma?
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Deep Regulatory Competence: Years of specialized experience in navigating the strict regulations of the Vietnamese Ministry of Health for pharmaceuticals and medical products.
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Asean Directives Alignment: Our team is highly proficient in the ASEAN Common Submission Dossier Template (CSDT), bridging the gap between global manufacturing standards and local mandates.
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Uncompromised IP & Data Security: We understand that technical dossiers contain confidential blueprints and clinical data. We guarantee absolute intellectual property protection.
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End-to-End Route-to-Market: From initial legal feasibility to customs clearance and final distribution setup, we are your single point of accountability.
Accelerate Your Healthcare Expansion in Vietnam
Partner with a compliance expert who understands the vital importance of medical precision. Contact our international business development department today for an initial regulatory assessment.
SUMPHARMA – Vietnam’s Leading Company for the Import of Health Supplements, Cosmetics, and Medical Devices
Sum Pharmaceutical Investment Joint Stock Company
Headquarters: 11th Floor, West Tower, Hancorp Building, 72 Tran Dang Ninh Street, Nghia Do Ward, Hanoi City, Vietnam.
Southern Branch: 4th Floor, C.T Building, 56 Yen Thế Street, Ward 2, Tan Binh District, Ho Chi Minh City, Vietnam.
Hotline: +84 243 212 1820
Email: cskh@sumpharma.vn
