Import Procedures for Contact Lenses Conducted by Ipologistics

1. Introduction

Contact lenses have become an essential product in the eye care industry, providing convenience and aesthetics for users. With the growing demand, importing contact lenses into Vietnam must comply with strict legal regulations and quality standards. This article will delve into the import procedures for contact lenses conducted by Ipologistics, including HS codes, legal basis, state regulations on licenses, and product quality inspections.

2. Legal Basis for Importing Contact Lenses

2.1. Vietnam Drug Law

2.1.1. Drug Law No. 105/2016/QH13

• Date of enactment: April 6, 2016.
• Content: This law regulates the conditions for the production, trading, and circulation of drugs and medical products, including contact lenses. Specifically, Article 2 outlines the management subjects, while Article 16 stipulates the conditions for issuing a circulation license for products.

2.1.2. Decree No. 54/2017/ND-CP

• Date of enactment: May 8, 2017.
• Content: This decree provides detailed regulations on the management of drugs and medical products, specifying the registration, licensing, and quality inspection processes for medical products. Article 13 outlines the issuance of the product circulation license, applicable conditions, and implementation procedures.

2.1.3. Circular No. 01/2018/TT-BYT

• Date of enactment: January 2, 2018.
• Content: This circular guides the implementation of Decree No. 54, providing specific regulations on the registration dossier, appraisal process, and quality inspection for medical products.

2.2. International Standards

2.2.1. ISO 13485 Standard

• Content: This standard specifies the quality management system requirements in the field of medical devices, requiring manufacturing and supplying organizations to have processes and policies to ensure quality.

2.2.2. CE Marking

• Content: This certification is a mandatory requirement for medical products when circulated in the European market, ensuring the product meets safety and health requirements.

3. HS Code (Harmonized System)

• HS Code for contact lenses: The HS code applied for contact lenses is 9001.30. This code helps classify products in customs procedures, ensuring control and monitoring of goods during the import process.

4. Import Process for Contact Lenses

The import process for contact lenses in Vietnam involves several important steps, from market research to customs clearance. Below is the detailed process that Ipologistics follows:

4.1. Market Research and Supplier Selection

4.1.1. Market Demand Analysis

• Market research: Evaluate consumer trends and market demand for contact lenses in Vietnam. This includes surveying consumers and analyzing market data from research organizations.

4.1.2. Supplier Selection

• Finding suppliers: Choose reputable contact lens manufacturers, ensuring they have quality certification and can supply on time.

4.2. Product Registration

Before proceeding with import, the company needs to perform the following steps:

4.2.1. Prepare Registration Dossier

The registration dossier needs to include:

• Product registration application: According to the model prescribed by the Drug Administration.
• Product description documents: Product name, components, intended use, instructions for use, technical information, and product images.
• Quality certification: From the manufacturer, including ISO and CE certifications.
• Business registration certificate: Providing information about the company.
• Product samples: For new products or at the request of authorities.

4.2.2. Submit Registration Dossier

• Where to submit: The Drug Administration under the Ministry of Health.
• Processing time: Approximately 30 working days.

4.2.3. Receive Circulation License

After the dossier is approved, the company will receive a product circulation license, allowing the importation of contact lenses.

4.3. Establish Import Contract

4.3.1. Sign the Contract

• Agreement in the contract: Clearly state the quantity, quality, price, payment method, and delivery time.

4.3.2. Execute Payment

• Payment methods: Can be made through international bank transfer or letters of credit (L/C) as agreed in the contract.

4.4. Transportation of Goods

4.4.1. Choose the Transportation Method

• International shipping: Can choose shipping by sea or air depending on time and cost requirements.

4.4.2. Track the Order

• Monitor order status: Ensure that goods are transported on time and to the right location.

4.5. Customs Clearance Procedures

4.5.1. Prepare Customs Clearance Dossier

Documents required include:

• Commercial Invoice: Determines the value of the goods.
• Packing List: Details about quantity and weight of the goods.
• Product circulation license: Necessary documents to prove the legality of the product.
• Quality certification: Required by regulatory authorities.
• Shipping documents: Bill of Lading or Air Waybill.

4.5.2. Submit Dossier to Customs Authorities

• Where to submit: Customs authority where goods are imported.
• Processing time: Usually from 1 to 3 working days, depending on the volume and nature of the goods.

4.5.3. Goods Inspection

• Inspection process: Customs authorities will check the validity of the documents and the quality of the goods. If the goods meet the requirements, the customs authority will issue a Customs Clearance Certificate.

4.6. Receiving Goods and Storage

4.6.1. Receiving Goods

• Conducting the receiving: The company proceeds to receive the goods at the warehouse and check the quality.

4.6.2. Quality Inspection

• Product quality inspection: Ensure that the products meet the registered standards before distribution.

4.6.3. Storage

• Storage conditions: Contact lenses need to be stored under appropriate conditions (temperature, humidity) to ensure product quality.

4.7. Product Distribution

4.7.1. Distribution Plan

• Distributing through sales channels: Can be through pharmacies, medical facilities, or online sales channels.

4.7.2. Training Programs

• Employee training: Ensure that staff have adequate knowledge about the products to advise customers.

5. Quality Control

Quality control is a crucial factor in ensuring the safety and effectiveness of the products. Ipologistics is committed to implementing:

5.1. Quality Control Procedures

5.1.1. Establishing Strict Quality Control Procedures

• Periodic inspections: Organize periodic inspections of batches to ensure there are no inconsistencies in product quality.

5.1.2. Handling Incidents

• Incident handling procedures: If substandard products are discovered, the company will implement recall and handling according to regulations.

5.2. Supplier Evaluation

• Periodic evaluations: Conduct evaluations of suppliers’ quality and reputation to ensure products consistently meet the highest standards.

6. Conclusion

The import process for contact lenses in Vietnam is a complex process that requires strict adherence to legal regulations. Ipologistics is committed to carrying out this process professionally and effectively, from market research, product registration, to customs clearance and product distribution. By fully complying with legal and quality regulations, the company ensures that consumers receive safe and high-quality contact lens products.