Disposable health protection gloves are typically made of thin rubber sheets or films. In industries where gloves are frequently changed, using disposable gloves not only effectively prevents cross-contamination but also significantly saves costs. These gloves are widely used in sectors with high hygiene requirements, such as healthcare, laboratories, and food processing.
What certification requirements do gloves need to meet when exported to different countries?
EU : An EU Free Sales Certificate (FSC) is required. The only organizations authorized by EU directives to issue FSCSs are the Competent Authorities (CAs) of European Economic Area (EEA) member states. If a product has been CE-marked and registered in accordance with the relevant EU directives, Chinese manufacturers generally do not need a FSCS when exporting to the EU. However, if a CE certificate is used for registration in a non-EU country, some governments may still require a FSCS issued by the EU government.
Australia : TGA registration is required. The TGA, short for the Therapeutic Goods Administration, oversees the regulation of therapeutic goods, including pharmaceuticals, medical devices, genetic technologies, and blood products. Australia categorizes medical devices into Class I, Is and Im, IIa, IIb, and III, a classification system largely consistent with that of the EU. If a product has received the CE mark, its Australian classification can generally be determined based on the CE classification.
Canada : CMDCAS (Canadian Medical Device Conformity Assessment System) certification is required. All medical devices sold in Canada, whether manufactured or imported, must be evaluated and licensed by Health Canada under CMDCAS. Health Canada requires manufacturers to obtain a registration certificate certified by CMDCAS to demonstrate compliance with Canadian medical device regulations.
South Korea : KFDA registration is required. The Ministry of Health and Welfare (MHW) of South Korea is primarily responsible for the management of food, drugs, cosmetics, and medical devices. Its subordinate Ministry of Food and Drug Safety regulates medical devices in accordance with the Medical Device Act. South Korea classifies medical devices into four categories (I, II, III, and IV), which are similar to the EU classification method:
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Class I: medical devices with almost no potential risks;
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Class II: medical devices with low potential risk;
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Class III: medical devices with moderate potential risks;
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Class IV: High-risk medical devices.
Japan : PMDA registration is required. Medical devices entering the Japanese market must comply with Japan's Pharmaceutical and Medical Device Act (PMD Act). Under this law, domestic manufacturers must register factory information, including product design, production, and key process details, with a government-authorized local authority. Foreign manufacturers, on the other hand, must register their manufacturer information directly with the PMDA (Pharmaceuticals and Medical Devices Agency).
