Healthcare Import Modernization: Ministry of Health Issues Standardized Framework for State Food Safety Inspections on Imported Goods

Key Development

To resolve operational bottlenecks during customs clearance and ensure consistent enforcement of state food safety regulations, Dr. Chu Quoc Thinh, PharmD—Director General of the Food Safety Agency (Ministry of Health)—has officially issued detailed guidance directives to food and food additive manufacturers, importers, and distributors nationwide.

The regulatory framework clarifies legal references and inspection pathways for imported commodities specified under Circular No. 15/2024/TT-BYT (which designates HS-coded food products, food additives, and food-contact packaging subject to state inspection) in conjunction with Decree No. 15/2018/ND-CP.

Standardized Regulatory Pathways by Commodity Category:

1. Food Additives Listed in Circular 15/2024/TT-BYT: Mandatory compliance with state food safety inspection procedures as prescribed.

2. Listed Commodities NOT Intended for Food Use: Products listed in Circular 15/2024/TT-BYT imported for non-food, non-additive, or non-processing aid industrial applications are EXEMPT from state food safety inspections (pursuant to Point b, Clause 4, Article 3 of Circular 15/2024/TT-BYT).

3. Raw Materials for Export Manufacturing or Internal Production: Fully EXEMPT from product self-declaration and EXEMPT from state food safety import inspections (unless an official food safety alert is active) pursuant to Clause 2, Article 4 and Clause 7, Article 13 of Decree No. 15/2018/ND-CP.

4. Health Supplements (Nutraceuticals): Importers must submit Product Registration Certificates to the Food Safety Agency. Once a Product Registration Receipt is granted, the product is EXEMPT from state food safety import inspections during customs clearance (unless flagged by food safety alerts) pursuant to Article 13 of Decree No. 15/2018/ND-CP.

5. HS Code (Commodity Classification) Discrepancies: In cases involving tariff classification disputes or HS code mismatches, enterprises are directed to consult directly with local Customs authorities for classification guidance.

Why It Matters

• Eliminating Customs Bottlenecks at Ports of Entry: Inconsistent interpretations between port health inspectors and Customs officials (specifically regarding industrial vs. food-grade chemical additives) previously created import delays. The updated guidance establishes transparent compliance boundaries.

• Supporting Export-Oriented Manufacturing: Confirming full exemptions from self-declaration and state inspections for raw materials imported exclusively for export processing or internal manufacturing reduces compliance costs for export enterprises.

• Streamlining Health Supplement Imports: Clarifying that health supplements holding a valid Product Registration Receipt do not require repetitive state testing upon each arrival accelerates market entry for licensed nutraceutical brands.

Healthcare Insight Analysis

From the perspective of Healthcare Insight, the August 7, 2026 guidance directive issued by the Food Safety Agency aligns with Supply Chain Food Safety Governance & Testing Infrastructure Optimization outlined under Politburo Resolution No. 72-NQ/TW.

This segmented regulatory approach reflects modern risk-based governance:

1. Intended-Use Regulatory Alignment: Prevents blanket testing that consumes public administrative resources. For identical chemical compounds (e.g., Citric Acid or Sodium Benzoate), shipments designated for industrial or cosmetic use are managed under respective sectoral regulations, triggering state food safety controls only when declared for food applications.

2. Eliminating Redundant Pre-Market Inspections: For health supplements, the Product Registration Certificate evaluation represents a rigorous pre-market safety assessment. Waiving repetitive border inspections for registered products reduces port storage and demurrage expenditures for compliant importers.

Enhancing regulatory predictability facilitates customs clearance for compliant trade while allowing regulatory authorities (FSA, General Department of Customs, and certified testing centers) to focus resources on monitoring high-risk flagged shipments.

Market Implications

1. Accelerated Customs Clearance for Health Supplements: Importers of licensed health supplements save 5 to 7 business days per shipment by leveraging state inspection exemptions supported by valid registration receipts.

2. Promoting FDI in Export Food Processing: Inspection exemptions for export processing raw materials provide regulatory certainty for multinational food manufacturers expanding facilities in Vietnam.

3. Inter-Agency Customs-Health Alignment: Establishing clear responsibility protocols for HS code classifications minimizes valuation and classification disputes at border checkpoints.

Regulatory Matrix: Imported Food Safety Inspection Pathways

Imported Commodity Group	Governing Statutory Reference	State Food Safety Inspection & Compliance Mandate
Listed Food Additives	Circular 15/2024/TT-BYT	Mandatory state food safety import inspection.
Non-Food Industrial Goods	Point b, Cl. 4, Art. 3, Cir. 15/2024	EXEMPT from state food safety inspections.
Export/Internal Raw Materials	Cl. 2 Art. 4 & Cl. 7 Art. 13 Dec. 15/2018	EXEMPT from self-declaration & state inspections (unless flagged).
Health Supplements	Art. 6, 7, 8, 13, 37 Dec. 15/2018	File registration; Receipt grants EXEMPTION from border inspection.
HS Code Classification Mismatch	Local Customs Authority	Direct consultation with Customs for tariff alignment.

Source: https://suckhoedoisong.vn/bo-y-te-huong-dan-thong-nhat-kiem-tra-an-toan-thuc-pham-doi-voi-hang-nhap-khau-169260807135955545.htm