PROCEDURES FOR IMPORTING CLASS A MEDICAL DEVICES

I. Introduction to Class A Medical Devices

IMPORTING CLASS A MEDICAL DEVICES – Class A medical devices are products with the lowest risk in the classification system for medical devices. According to the regulations of the Ministry of Health, Class A medical devices include products such as medical gloves, bandages, basic healthcare tools, and other devices that do not pose significant dangers to users.

Characteristics of Class A Medical Devices

• Low risk: They do not pose a significant threat to human health.
• Simplified inspection process: They do not require as strict inspections as other types of medical devices.
• Easy to produce and distribute: These devices are typically manufactured with simple processes.

II. Legal Basis

1. Law on Pharmacy 2016: Regulates the management of pharmaceuticals and medical devices, clearly defining the rights and obligations of the relevant parties.
2. Decree No. 36/2016/ND-CP: Detailed regulations on the management of medical equipment, including the procedures for obtaining permits and quality inspections.
3. Circular No. 30/2015/TT-BYT: Guidelines for classification and registration of medical devices.
4. Circular No. 08/2018/TT-BYT: Regulations on quality inspection of medical devices.
5. Law on Customs 2014: Regulations on customs procedures for imported goods.

III. Procedures for Importing Class A Medical Devices

The procedures for importing Class A medical devices include the following detailed steps:

Step 1: Classify Medical Devices

• HS Code: Class A medical devices are usually classified under HS code 9018 for medical devices and other codes depending on the specific type of device. Businesses need to look up specific codes in the Import-Export Tax Schedule or the General Department of Customs’ system.

Step 2: Prepare Import Documents

Businesses need to prepare the following documents:

1. Import registration application: Provide detailed information about the medical device, manufacturer, and purpose of use.
2. Quality certificate: Certifying that the product meets quality standards, usually issued by an authorized organization in the producing country.
3. Commercial invoice: Proving the origin and value of the goods.
4. Certificate of origin (C/O): If the goods are produced abroad, a certificate of origin is required.
5. Import permit: If the product falls under the category requiring import permits according to the Ministry of Health’s regulations.

Step 3: Register and Obtain Registration Number

Businesses submit their medical device registration application to the Department of Drug Administration – Ministry of Health. This agency will review the application within 15-30 working days. If the application is valid, the business will receive a registration number for the medical device.

Step 4: Quality Inspection of the Product

Before importation, Class A medical devices may need to undergo quality inspection. Specifically:

• Inspection at the manufacturing facility: Medical device manufacturers need to be inspected and confirmed to meet standards.
• Random inspection at the border: Customs authorities have the right to inspect the quality of imported goods to ensure compliance with regulations.

Step 5: Conduct Customs Procedures

1. Prepare customs documents:
   • Customs declaration form.
   • Medical device registration certificate.
   • Documents proving the origin of the goods.
2. Submit documents to customs: Businesses need to submit their documents to the local customs authority where the goods are imported.
3. Conduct customs inspection: The customs authority will carry out a physical inspection of the goods and related documents.

Step 6: Receive and Store Goods

After completing the customs procedures, businesses can receive the goods and need to follow the storage steps:

• Store medical devices: Ensure devices are stored under standard conditions to avoid quality deterioration.
• Record information: Maintain records of the import process for future inspections by authorities.

IV. State Regulations on Permits and Quality Inspection

Import Permit

• Import permit: Class A medical devices are generally not items that require import permits. However, if the products originate from countries with health risks, businesses may need to obtain an import permit from the Ministry of Health.

Product Quality Inspection

• Quality certification: Depending on the type of medical device, a quality certificate from an authorized agency in the producing country may be required.
• Random inspections: Regulatory authorities will conduct random inspections at customs to ensure that products meet standards before clearance.

V. Conclusion

The procedures for importing Class A medical devices require meticulous preparation and strict adherence to current legal regulations. Businesses need to clearly understand the process, from classification and document preparation to customs procedures, to ensure that their goods are imported legally and safely.

Ipologistics is committed to providing consulting and support services to customers during the importation of Class A medical devices, ensuring that all procedures are carried out quickly, effectively, and in compliance with legal requirements. We are always ready to assist businesses in addressing arising issues and ensuring that the import process runs smoothly.