Gangan Medical has been awarded the EU MDR certificate
Recently, Gangan Medical Technology Jiangsu Co., Ltd. (hereinafter referred to as Gangan Medical) successfully passed the product certification (REGULATION (EU) 2017/745, abbreviated as MDR) under the strict upgrade of EU medical device regulations, 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 in the medical device industry, which is the passport for manufacturers to enter the European market, ensuring that the products meet the 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 organization, issued a notified body CE conformity certificate based on the EU Medical Device Regulation (EU) 2017/745 (MDR) for Reusable Injection Pen and Injection Pen Needle produced by Gangan Medical. Prior to this, Gangan Medical had obtained the EN ISO 13485 and MDSAP 2016 (USA, Canada) quality management system certification issued by TUV Rheinland.
This award of MDR certificate fully demonstrates the high standard level of product quality and research and development technology of Gangan Medical, and also reflects the great recognition of the international authoritative certification body for the safety, effectiveness, and product quality management system of medical devices developed and produced by Gangan Medical.
EU Medical Device Regulations
On May 5, 2017, the Official Journal of the European Union officially released MDR to replace the original Medical Device Directive MDD (93/42/EEC).
From Directive to Regulation, the EU has increased its binding force on medical devices, and once MDR is issued, it immediately takes effect in EU member states and becomes binding law. Strengthening supervision has also increased the difficulty and cost of certification. The release of MDR has effectively improved the safety and effectiveness of medical devices, supporting transparency in the entire European medical device market.
The products approved this time are Reusable Injection Pen and Injection Pen Needle.
Reusable Injection Pen is classified as a Class IIb medical device in the EU, which is a medium-risk product. This injector is compatible with 3ml Ganli Cartridge and helps patients, healthcare professionals and caregivers deliver accurate doses of multiple-dose rapid-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 low to medium risk category. It is intended to be used in conjunction with a pen syringe for subcutaneous injection of drugs (insulin, liraglutide injection, recombinant human hormone injection).
Reusable Injection Pen and Injection Pen Needle have long been common medical devices for subcutaneous injection of insulin drugs by diabetic patients. In recent years, many subcutaneous injection drugs can be administered using Reusable Injection Pen, and the intended uses of Injection Pen Needle have also expanded accordingly.
Gangan Medical Technology Jiangsu Co., Ltd. is a high-end medical device production base that integrates high technology, innovation, and specialization. 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 research and development of insulin injection products. Injection Pen Needle developed and produced by Gangan Medical - Xiulin Needle ® The application has been approved for pre-market registration by the US Food and Drug Administration.