Import medical products
Sanitary products are among the most detained at customs due to lack of knowledge about import regulations and the complexity of their processing. Whether you have a sanitary product import license or not, we offer personalized studies, solutions, and services for importing sanitary products without having to bear the fixed costs of personnel and warehouse required by the AEMPS. We offer both personalized studies and unique DDP (Delivered Duty Paid) shipments (product delivered to your door) throughout Europe.
Import sanitary products
The import of sanitary products from China, India, and other countries has been growing over the years due to the highly competitive prices associated with importing sanitary products in their different classes or classifications given by the AEMPS.
The biggest problem many companies in the sector face is the lack of a license to import sanitary products along with the uncertainty of buying from a company located in China, India, Hong Kong, or other countries, and the lack of knowledge about all the processes that regulate importation.
The importer of sanitary products is responsible not only for importing with the necessary precautions but also for handling any claims that may be made by authorities in the years following the importation. Therefore, receiving the product does not exempt them from any future claims.
Import sanitary products without an import license
With Bull Importer, a company authorized by AEMPS, your company can import sanitary products without an import license with the following advantages:
- You will be able to import all Class I, II, and III Medical Devices and In Vitro Diagnostic Medical Devices without an import license.
- You will not need to hire a person responsible for regulatory compliance according to the MDR regulation or a technical manager as stated in Royal Decree RD 1591/2009, October 16.
- You will not need to have a warehouse approved by AEMPS or special facilities controlled by a technical manager.
- Since Bull Importer will be the importer on your behalf, we will ensure that the product has the correct CE marking and the EU declaration of conformity has been prepared.
- With our international offices, we will verify that the manufacturer is identified and has designated an appropriate authorized representative.
- We will check that a unique identifier has been assigned and that the product is correctly labeled in accordance with the Regulation and accompanied by the proper instructions for use.
- Everything will be reviewed by our ‘Technical Guarantor’ who will supervise the process and ensure compliance.
- At the same time, we will verify that all the documentation from the manufacturer or supplier is correct, including the commercial invoice, transport documents, and packing list.
- You will know the final price before importing. To achieve this, we will study the entire process and provide you with DDP import cost calculations (product delivered to your company) with all costs included in a single invoice. This way, our methodology will relieve you of the complexity of importing and managing all the different parties involved in the process, such as customs agents, tax authorities, freight forwarders and logistics operators, insurance companies, and banks… everything will be handled by a single company, Bull Importer.
- You will enjoy a comprehensive and secure process with more than 27 years of experience and thousands of imports completed.
- You can repeat the process as many times as you want without having to bear fixed costs or claims.
Import sanitary products from China, India, Korea, or Hong Kong
At Bull Importer, we have our own offices in China and India and representatives in Korea and Hong Kong to ensure that the entire purchasing and importation process for our clients is completely guaranteed. You can import sanitary products from China, India, Korea, or Hong Kong whether you have your own license or not, ensuring the entire process and making sure that your company (if the importation is in your name) will comply with all the commitments and requirements demanded by the AEMPS.
At Bull Importer, we have extensive experience in importing all kinds of sanitary products, including Class I, IIA, IIB, III, and In Vitro Diagnostic Medical Devices, having imported all related products, which include:
Bandages and dressings, syringes and needles, incontinence absorbents, surgical masks, disposable adhesives, orthopedic footwear, cannulas, surgical gloves and examination gloves, disposable scalpels and scalpel blades, dressings, gels, non-woven surgical clothing, surgical drapes and textile surgical clothing, hearing aids, thermometers, tonometers, non-woven wound care material, silicone orthopedic products, mattresses, pillows, cushions and other anti-decubitus products, wheelchairs and walkers and mobility aid systems, insoles, cotton and cotton wound care material, packaging for sterilization of reusable products, lamps, lights and negatoscopes, drug administration products, stethoscopes, hospital furniture, contact lenses, glasses and corrective lenses, therapeutic elastic material, Axen™ COVID-19 Ag Rapid Test, Axen™ COVID-19 Ag IgM/IgG Rapid Test, and blood glucose monitoring systems, among others.
Each importation of sanitary products is different, so we will meticulously review each purchase and importation of sanitary products to comply with the requirements and regulations, discarding those that pose a serious danger or are counterfeit.
Manufacturers of sanitary products from China, India, Korea, or Hong Kong
We can import and supply any type of product while following the quality standards that your company needs, ensuring that your final product maintains the essence of your identity. We offer completely personalized services. Having our own offices in China and India and representatives in Korea and Hong Kong allows us to meet the needs of our clients by locating the best manufacturers of sanitary products in China, India, Korea, or Hong Kong. We oversee the entire process from production to delivery of the product to our clients’ facilities.
Starting point for importing sanitary products
The first thing we need to know is whether you already have a factory with which you have established a business relationship and have defined the management you want to carry out. In this case, you will need to provide us with the following documentation:
- Negotiated invoice with the manufacturer
- Packing list of the order
If you have not located the manufacturer(s), we will thoroughly examine your case to identify all your needs. If you agree with our services, we will initiate a comprehensive search management process. Our goal is to ensure that the final price delivered to your facilities meets your expectations. Equally important is ensuring that the manufacturer has all the necessary documentation and certificates in order. These will be audited by our team of experts to ensure that the final proposal is firm in all aspects and contents.
Our steps to follow will be:
- Having all the documentation from the supplier or manufacturer
- Verifying that the technical requirements of the supplier or manufacturer comply with the European regulations applicable to them, discarding companies that do not manufacture safely.
- Preparation of a technical report where we classify the product in terms of regulations and its approval, avoiding products that cannot be sold in the European Union.
- Handling all the technical documentation and necessary reports related to the importation at the Spanish Agency of Medicines and Medical Devices (AEMPS).
- Carrying out the procedures required by Authorities and Notified Bodies, managing any claims that may arise, traceability, storage, inspection, and/or reception control of the products.
- Checking the correct labeling and CE marking of the product along with the corresponding technical file for CE marking or Technical File.
Get informed here to import sanitary products with complete peace of mind.
Today more than ever, there are rigorous controls on the marking corresponding to products such as customs inspections, aimed at preventing the entry of products with warranty defects. Therefore, before proceeding with an importation at your own risk, you must ensure that all requirements imposed by the European Union in terms of health are met. At Bull Importer, we offer comprehensive support in all phases of the purchasing and importation process to ensure the highest chances of success, whether you already have your supplier or if there is a need to locate manufacturers and suppliers that can meet your expectations.
Forget about having to present, document, and prepare a series of procedures necessary for the proper importation and sale of sanitary products or doubting whether the supplier or manufacturer is legal or falsifying information, reasons why hundreds of thousands of imports of sanitary products are detained at customs, among others. At Bull Importer, we take care of everything from the most tedious to the most sophisticated aspects, whether you have an import license or not because having one or not never guarantees the success of an importation that has not been properly planned.
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