The new COVID-19 pandemic affected all over the world. There were over Two million cases diagnosed in the world. All countries are facing shortage of medical supplies. As the main manufacturing location in the world, China has also actively undertaken the important role of manufacturing of PPE medical caused for the world. Since March 2020, China has exported over 3.86 billion pieces of surgical masks, 37.52 million pieces of protective clothing, and 16,000 breathing machines.
Due to the huge amount, there were challenges from stakeholders among these medical supplies, For example: The quality control of the product, different quality standards of China and foreign countries, and differences in usage habits and which would affect overall product quality. Facing with the current situation, relevant China government department had emphasize the need to strengthen the supervision of these exported medical materials. It has focus on five types of products, which needed to fulfil the requirements strictly:
l Testing reagents
l Medical masks
l Medical protective clothing
l Ventilators
l Infrared thermometers
The exporters needed to obtain the registration certificate of medical device produced in China and meet the quality standards of the importing country (region). The medical & PPE products are now mainly exporting to the EU market. These countries have their own import requirements for different medical & PPE products.
It would include CE certification, Medical Device Directive 93/42 / EEC (MDD), Medical Device Regulations EU2017 / 745 (MDR), ISO 13485 Medical Device Quality Management System, Personal Protection Equipment Regulations EU2016 / 425 (PPE), etc.
l What products need to meet what standards?
l How to fulfil the standard requirements?
l Which certification is required for which particular product?
l What is the process to undertake these certificates?
On 20th May 2020, World Center for Certification & Quality senior experts in the medical field will give you detailed answers to the knowledge of testing, inspection and certification of the entire supply chain: From procurement, manufacturing, trade to retail so to help the organization to export the medical supplies products (such as surgical masks) to the world successfully.
