In the context of the increasingly developing medical industry, demand enter medical equipment increasingly to serve medical examination and treatment, improve the quality of medical services. Businesses, hospital, clinic, Distributors aim to expand the supply of medical equipment from international markets to ensure diversity, Modern and consistent with international standards.

However, job import medical equipment is not simply the process of buying and selling goods across borders. This is an activity that requires a clear understanding of legal regulations, customs procedures, Quality certification and related documents. Because it is a sensitive product group, errors can easily occur during the procedure, leading to additional costs, delay, or even goods that are withheld or not allowed to circulate.

That's why, This article will provide the necessary knowledge, from device classification, file, process to common mistakes and ways to save time, cost when import medical equipment. Our goal is to help businesses clearly understand the process, avoid errors, thereby optimizing import activities, Ensure goods arrive on schedule, according to regulations.

Classification of medical devices & Legal basis for import

Job import medical equipment Businesses are required to clearly identify the type of goods based on current legal regulations. According to Decree 98/2021/ND-CP, Medical devices are divided into 4 groups according to risk level:

• Group A: Low risk, includes items such as cotton, gauze, Medical masks... Most of this group do not require a circulation permit for import.
• Group B: Medium risk, includes equipment such as blood pressure monitors, Electronic thermometer... Requires a circulation permit.
• Group C: Medium high risk, devices such as ventilators, Handheld diagnostic machines... require a license for circulation and certification of standards.
• Group D: Highest risk, Includes surgical equipment, Image diagnostic equipment... requires an import license and declaration of conformity.

Important legal bases related to import medical equipment including:

• Circular 05/2022/TT-BYT: Regulations on import management, circulation of medical equipment.
• Decree 98/2021/ND-CP and Decree 07/2023/ND-CP: Modify, Supplementing import regulations, classify, license.

Therefore, Enterprises need to clearly identify product groups to prepare complete documents, appropriate documents, In particular, groups B–D are required to have a circulation permit to be eligible for import and circulation in Vietnam.

See more: Customs clearance services

Documents for importing medical equipment

Profile to import medical equipment includes two main groups: Basic customs records and specialized records.

1. Basic customs records:

• Commercial contract (Contract): Proof of origin and terms of sale.
• Commercial invoice (Invoice): Value of goods, quantity, describe.
• Packing slip (Packing List): Details of the packages, weight, size.
• Bill of lading (Bill of Lading / Airway Bill): Shipping documents.
• Certificate of origin (C/O): If any, help enjoy tax incentives or prove origin.

2. Specialized profile:

• Medical device circulation number or import license: Issued by the Ministry of Health, mandatory for groups B–D.
• Equipment catalog / Brochure: Show characteristics, technical features.
• ISO 13485 certification: Certification of quality management system in accordance with international standards.
• Medical device classification declaration: For goods not yet in circulation, Helps determine the correct HS code.

Note, Businesses should work with experienced logistics units like Cuong Quoc Logistics to review, Support in preparing complete documents, Avoid errors when carrying out procedures.

Procedures for importing medical equipment

This process includes main steps, Ensure goods are cleared through customs according to regulations:

Step 1: Check device group policies and classifications

• Determine whether the goods require an import license or only a marketing license based on group classification.

Step 2: Prepare declaration documents or import licenses

• Send documents to the Ministry of Health or authorize a professional logistics unit such as Cuong Quoc Logistics to handle.

Step 3: Open customs declaration & Specialized inspection

• Attach license, goods classification, catalog and related documents in the declaration.

Step 4: Pay taxes & customs clearance

• Payment of import tax, Inspect the goods if necessary or conduct a physical inspection.

Step 5: Receive & record storage

• Complete the procedure, receive, At the same time, store legal records to serve accounting work, check later.

5 common mistakes that cost businesses money

In process import medical equipment, Many businesses make common mistakes that cause costs or delays:

1. Wrong declaration of HS code: Leading to tax arrears or audits, keep the goods.
2. Missing license or circulation number: Not eligible for customs clearance, leading to goods being held back or sold slowly.
3. The label does not match the published records: Must be re-glued, editing or fact checking, causes time wasting.
4. No technical documents prepared, catalog: Slows down processing, causing storage costs.
5. Do not work with a specialized logistics unit: Generate cont storage, Luu Bai, incur unnecessary costs.

Cuong Quoc Logistics has handled many cases of goods being stuck due to incorrect records, Helps customers shorten processing time to 2-3 days, Significant savings in costs and effort.

Experience helps save time and costs

To optimize operations import medical equipment, Businesses need to apply the following strategies:

• Correctly classify product groups Before signing the contract to prepare appropriate documents.
• Prepare documents in parallel with the shipping process to shorten time.
• Guaranteed label, Documents match 100% with registered license.
• Take advantage of tax incentives from C/O certificates from exporting countries such as China, Korea, ASEAN.
• Use comprehensive logistics services from reputable units to limit errors and eliminate unnecessary intermediaries.

Why should you choose Cuong Quoc Logistics when importing medical equipment?

With more than 10 years of experience in the logistics field, especially the medical equipment group, pharmaceutical, cosmetics, Cuong Quoc Logistics is proud to be a trusted partner of many businesses import medical equipment:

• Full support: Profile consultation, customs declaration, Apply for a license from the Ministry of Health.
• Monitor progress 24/7: Quickly handle arising issues, ensure progress.
• Commitment to on time customs clearance: Cost transparency, clearly in the contract.
• Professional team: Understand the process, Update the latest regulations.

Choosing Cuong Quoc Logistics is the optimal choice import medical equipment safely, effective, Save time and cost, Helps businesses feel secure in developing their business activities.

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This is the main content about the section “Main title” trong outline, Focus on the knowledge and experience to import medical equipment according to regulations, Avoid mistakes and optimize costs.

Conclude

In this article, We have clearly stated the important steps to carry out procedures for importing medical equipment accurately and effectively. Equipment classification is based on legal regulations, Preparing complete and correct documents is a key factor to help businesses avoid costly errors. Simultaneously, We have also pointed out 5 common mistakes such as declaring the wrong HS code, Missing license or mismatched records, may result in the goods being detained or fined.

Experience from practice shows, Document preparation parallel to the transportation process, Choosing a reputable logistics partner and taking advantage of tax incentives will help save significant time and costs.

With more than 10 years of experience in the field of importing medical equipment, Cuong Quoc Logistics is proud to become a trusted partner, Providing a full package of services from legal advice to handling customs procedures, Ensuring businesses comply with legal regulations, on time and optimize costs.

Thanks to that, Enterprises can rest assured to expand their business activities in the medical field in a sustainable and safe way. Overall, Mastering the process of importing medical equipment and cooperating with professional units will help businesses avoid legal risks., Minimize unnecessary costs and improve operational efficiency.