The Ministry of Health has issued Circular 19/2024/TT-BYT on October 1, 2024, to provide updated guidelines for exporting and importing medical devices. This circular introduces an official list of devices assigned Harmonized System (HS) commodity codes, aligned with the Vietnam Export and Import Goods Classification List (Circular No. 31/2022/TT-BTC). It aims to enhance regulatory clarity and facilitate smoother compliance for businesses operating in the medical device sector.
Key Updates
- Effective Date: November 16, 2024.
- Superseded Circular: Circular No. 14/2018/TT-BYT, dated May 15, 2018, will no longer be valid after this date.
Principles for Application
- Handling Discrepancies:
- In cases of inconsistency or dispute in the classification of HS codes, customs law will take precedence.
- Unlisted Medical Devices:
- HS codes for unlisted devices will also follow customs law. Exporters and importers must notify the Ministry of Health after clearance to update the list.
- Basis for Regulation:
- The list of medical devices with assigned HS codes serves as the framework for their legal export and import within Vietnam.
- Scope of Coverage:
- The regulations apply to medical devices covered under Decree No. 98/2021/ND-CP and its subsequent amendments or supplements.
Circular 19/2024/TT-BYT enhances the regulation of medical devices in Vietnam by setting clear guidelines for classification, import, export, and the use of HS codes. It promotes transparency, compliance, and safety in line with international standards. Companies engaged in the trade of medical devices are encouraged to stay informed and adhere to these new regulations to ensure smooth operations and regulatory compliance.
With 20 years of expertise in medical device registration, Qualtech Consulting is your trusted partner for staying compliant and thriving in Vietnam's evolving regulatory landscape. Let us guide you through Circular 19/2024/TT-BYT and beyond.
Contact us today to secure your regulatory edge!
References:
Circular 19/2024/TT-BYT dated October 1, 2024, Issuing the List of Exported and Imported Medical Devices that Have Been Assigned Commodity Codes According to the Vietnam Export and Import Goods Classification List. (In Vietnamese only)