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Home ? Medical Equipment ? Export of Surgical Blades

The EU Releases the New Version of the General Product Safety Regulation,

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The Singaporean government has recently introduced a new documentary requirement. According to the new documentary requirement, if the consignee or notify party is an individual, it needs to be shown as an individual C/O a Singaporean company.---
(b) Medical EquipmentOctober 30, 2024 12:34---

Export is an important part of international trade, and documents are an indispensable part of exports. Singapore is an important economy in Southeast Asia, and its foreign
(a) EPA Registration:---
(b) FDA Filing:trade is very active. In order to better regulate the export process, the Singaporean government has recently introduced a new documentary requirement.

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FDAs interim policy:According to the new documentary requirement

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(a) EPA and FDA Labeling Requirements:Ensure that the labels of all products comply with the requirements of the EPA or FDA. This includes ingredient lists, instructions for use, warnings, and manufacturer information.
(b) Safety Data Sheet (SDS):Prepare an SDS for the product, detailing its chemical properties, potential hazards, storage and handling guidelines, etc.

5、Quality Control and Safety Testing
(a) Quality Control:Ensure that the production process complies with the FDAs cGMP standards to guarantee product quality and safety.
(b) Safety and Efficacy Testing:Conduct necessary safety and efficacy tests to demonstrate that the product meets the requirements of the US market.

Continue to Extend the Non - imposition of Tariffs on 124 Categories of US Goods

Compliance with EU BPR regulation:Disinfection products exported to the EU need to comply with the EU Biocidal Products Regulation (EU BPR). This includes ensuring that active substances are approved, products are authorized, and listed on the list of qualified suppliers.
2、Chemical Registration and Evaluation:For non - active substances in disinfection products, if certain tonnage quantity requirements are met, registration under the EU Registration, Evaluation, Authorization and Restriction of Chemicals (EU REACH) regulation is also required.
3、Classification, Labeling and Packaging:According to the EU Classification, Labelling and Packaging of Substances and Mixtures Regulation (CLP regulation), the classification, labeling and packaging of disinfection products need to meet specific standards, and a Safety Data Sheet (SDS) compliant with EU standards should be prepared.

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Meeting K-BPR regulation:South Korea has implemented the Consumer Chemicals and Disinfection Products Safety Regulation (K - BPR) for disinfection products. Exporters need to ensure that their products comply with these regulations, including pre - notification of active substances and compliance assessment of products.
2、South Korea Chemical Substance Registration and Evaluation:Similar to the EUs REACH regulation, South Koreas K - REACH regulation requires the registration, evaluation, authorization and restriction of new chemical substances, existing chemical substances and downstream products.
3、Role of the Only Representative (OR):For chemical suppliers outside South Korea, an Only Representative (OR) needs to be appointed for chemical registration and notification in South Korea.

IV.Main Process of Exporting Disinfection Products

As a professionalExport Representationservice company, the following are the main processes for us to handle the export of disinfection products:

Our first step is to conduct an in - depth analysis of the target market to understand the specific regulations and standards for disinfection products in that market. This includes the EPA and FDA requirements in the US, the BPR regulation in the EU, the K - BPR regulation in South Korea, etc. Our expert team will continuously track the latest changes in these regulations to ensure that our clients are always in compliance.

After confirming the specific regulatory requirements of the target market, we will contact the client to ensure that all exported disinfection products fully comply with these requirements. This includes ingredient analysis, safety testing, and compliance review of labels and packaging. If necessary, we will also assist the client in obtaining the necessary certifications and approvals.

We will be responsible for preparing and submitting all necessary customs documents, including export licenses, commercial invoices, packing lists, etc. Our professional team will ensure that all documents are accurate to avoid any possible delays or additional costs.

Based on the clients needs and cost - effectiveness analysis, we will choose the most appropriate mode of transportation (such asMaritime Transportation,Air Transportationor land transportation) to transport disinfection products. We will also provide real - time cargo tracking services to ensure that clients can keep informed of the latest status of the goods at any time.

After arriving in the destination country, we will handle all customs clearance procedures to ensure that the goods pass through customs smoothly. In addition, we will coordinate the last - mile delivery to ensure that the goods reach the final destination safely and on time.

We provide comprehensive after - sales service, including consultation and solutions to any problems that may arise during the export process. Our goal is to ensure a smooth export process and customer satisfaction.