Recently, Gan Gan Medical Technology Jiangsu Co., Ltd. (hereinafter referred to as Gan Gan Medical) successfully passed the product certification (REGULATION (EU) 2017/745, abbreviated as MDR) and obtained the CE mark, becoming one of the first medical device manufacturers in China to obtain MDR certification under the new EU medical device regulations.
The CE mark represents that the product has passed the EU safety certification. All medical devices entering the EU market must undergo CE certification for the medical device industry, which serves as a passport for manufacturers to enter the European market, ensuring that products meet target market access requirements and comply with EU laws, regulations, and standards.
On November 22, 2022, TUV Rheinland, an international independent third-party testing, inspection, and certification agency, issued a CE conformity certificate based on the EU Medical Device Regulation (REGULATION (EU) 2017/745 (MDR) to pen insulin injectors and disposable injection pen needles produced by Gan Gan Medical. Prior to this, Gan Gan Medical has obtained the quality management system certification certificates issued by TUV Rheinland, including EN ISO 13485 and MDSAP 2016 (in the United States and Canada).
The MDR certificate obtained this time fully demonstrates the high standard level of product quality and research and development technology of Gan Gan Medical, as well as the great recognition of the safety, effectiveness, and product quality management system of medical devices developed and produced by Gan Gan Medical by international authoritative certification institutions.
EU Medical Device Regulations
On May 5, 2017, the Official Journal of the European Union officially released the MDR to replace the original Medical Device Directive (93/42/EEC).
From Directive to Regulation, the European Union has increased its binding force on medical devices, and once MDR is issued, it immediately takes effect in EU member states and becomes a binding law. Strengthening regulation has also increased the difficulty and cost of certification, and the release of MDR has effectively improved the safety and effectiveness of devices, supporting transparency in the entire European medical device market.
The products approved this time are pen insulin injectors and disposable injection pen needles.
The pen insulin syringe is classified as a medium risk product in the EU medical device classification level IIb. This syringe is compatible with a 3ml Gan Li cartridge bottle and helps patients, healthcare professionals, and nursing staff deliver accurate doses of multi dose fast acting or long-acting insulin drugs through subcutaneous injection.
The disposable injection pen needle is classified as Class IIa in the EU medical device classification and belongs to the medium and low-risk category. It is intended to be used in conjunction with pen syringes for subcutaneous injection of drugs (insulin, liraglutide injection, recombinant human hormone injection).
Pen type insulin injectors and insulin needles have long been common medical devices for subcutaneous insulin injection in diabetes patients. In recent years, many subcutaneous injection drugs can be injected using pen style syringes, and pen style injection needles have correspondingly expanded their intended use.
Gangan Medical Technology Jiangsu Co., Ltd. is a high-end medical device production base that integrates high technology, innovation, and specialization in Ganli. Gangan Medical has a building area of 12000 square meters and a total production area of 4500 square meters. It is mainly responsible for the production of medical devices, blood glucose monitoring for next-generation cloud data management, and the research and development of insulin injection products. The disposable injection pen needle developed and produced by Gangan Medical - Xiulin Needle ® The application has been approved by the US Food and Drug Administration for pre market notification.
