Class BCD Medical Devices

Detailed Import Procedures for Class BCD Medical Devices by Ipologistics

Class BCD Medical Devices – Importing medical devices in Vietnam requires strict compliance with legal regulations to ensure the safety and effectiveness of the products. Medical devices are classified into categories B, C, D based on their risk levels and usage. This article will provide a detailed guide on the import procedures for Class B, C, D medical devices, including HS codes, legal bases, necessary licenses, and product quality inspection requirements.

1. Definition and Classification of Medical Devices

According to Decree No. 36/2016/ND-CP, medical devices are classified as follows:

• Class A medical devices: Low risk, such as medical bandages, gloves.
• Class B medical devices: Moderate risk, including blood pressure monitors and nebulizers.
• Class C medical devices: High risk, such as ultrasound machines and ventilators.
• Class D medical devices: Very high risk, including implants and endoscopic instruments.

2. Legal Basis

The legal documents governing the import of medical devices include:

• The Law on Pharmacy 2016: Governs the management of pharmaceuticals and medical devices.
• Decree No. 36/2016/ND-CP: Provides guidance on the management of medical devices, including the procedure for applying for import licenses.
• Circular No. 30/2015/TT-BYT: Specifies the conditions and procedures for issuing import licenses for medical devices.
• Circular No. 44/2018/TT-BYT: Details the requirements for product quality inspection.

3. HS Codes for Medical Devices

HS codes (Harmonized System) are used to classify goods in international trade. Below are some common HS codes for Class B, C, D medical devices:

• Class B medical devices:
  • Blood pressure monitors: 9025.11
  • Nebulizers: 9019.20
• Class C medical devices:
  • Ultrasound machines: 9018.90
  • Ventilators: 9019.20
• Class D medical devices:
  • Implants: 9021.10
  • Endoscopic instruments: 9018.90

4. Import Procedures for Medical Devices

The import procedure for medical devices includes the following steps:

Step 1: Prepare the Application for Import License

1. Required documents:
   • Application for import license: Must be fully and correctly filled out according to the required form.
   • Business registration certificate: A notarized copy.
   • Certificate of quality from the exporting country: Documents proving that the device meets international quality standards.
   • Technical specifications and user manual: A detailed description of the product and its usage.
   • Product label sample: Must include full information as required by Vietnamese regulations.
2. Submit the application:
   • The application is submitted to the Drug Administration of Vietnam under the Ministry of Health. The processing time usually takes 15 to 30 working days.
3. Receive the import license:
   • If approved, the company will receive the import license, which allows them to proceed with the next steps of the import process.

Step 2: Product Quality Inspection

1. Inspection at the port:
   • Once the goods arrive at the port, the company must carry out quality inspections as required by Customs and the Drug Administration of Vietnam.
2. Sample testing:
   • Medical devices may require sample testing at designated laboratories. Companies need to prepare samples for inspection, and the results will be used to assess the product’s quality.

Step 3: Customs Clearance

1. Customs declaration:
   • The company must declare the imported goods to Customs. Required documents for customs declaration include:
     • Import license: A notarized copy.
     • Commercial invoice: Detailing the value and description of the products.
     • Bill of lading: The shipping documents.
     • Certificate of quality: Proof that the devices meet quality standards.
2. Tax payment:
   • The company must pay import taxes as per government regulations. The tax rate will depend on the HS code of the product.
3. Customs clearance:
   • After completing the customs declaration and tax payment, Customs will proceed with the clearance procedures. Once cleared, the goods will be released for distribution.

Step 4: Product Announcement and Distribution

1. Product announcement:
   • The company must file a product announcement with the Drug Administration of Vietnam before distributing the products in the market. Required documents for the announcement include:
     • Product announcement form: Must be filled out completely.
     • Certificate of quality: Proof that the product meets the required standards.
     • Product label sample: Must comply with product information regulations.
2. Distribution:
   • After the product announcement, the devices can be distributed and sold in the market.

5. License Requirements and Quality Inspection

• Manufacturing license and quality standards: All medical devices must meet quality standards according to Circular No. 44/2018/TT-BYT. Importing companies must provide ISO certification or equivalent certification from the manufacturer.
• Product quality inspection: The Drug Administration of Vietnam conducts quality inspections for imported medical devices. Sample devices may be sent to designated laboratories for testing and quality verification.

6. Important Notes for Importers

• Choose a reliable supplier: Companies should select reputable suppliers to ensure the quality of the medical devices.
• Compliance with legal regulations: Strict adherence to legal and procedural regulations is essential to avoid legal risks during the import process.
• Record keeping: Companies should maintain all documents related to the import process for future reference.
• Consult with experts: Working with professionals in the fields of import and pharmaceutical management can save time and ensure compliance with legal requirements.

7. Conclusion

The import of Class B, C, D medical devices is a complex process that requires strict compliance with legal regulations and the completion of all necessary steps. Ipologistics is proud to have a team of experienced logistics and import specialists, committed to supporting businesses throughout the entire process, from preparing documentation to bringing products to market.

If you need further information or specific consultation on the import procedures for medical devices, please contact us for the best support.