Success Stories

global growth partner to MedTech companies

Successful Case | Pure Global Helps Client Obtain Colombia Registration Certificate for COVID Test Kits in 48 Days!

This article describes the process of a medical device certification enterprise assisting its clients in obtaining a registration certificate for in-vitro diagnostic reagents in Colombia, one of the largest medical device markets in South America, which is regulated by INVIMA and classified by risk level for product approval. Through Pure Global 's professional services, the client successfully obtained the registration certificate in Colombia in 48 days. Pure Global provides end-to-end professional services for medical device manufacturers to expand into overseas markets.

2021-12-02

Success Story | Pure Global Helps Yingke New Tech Obtain EU HSC Common List Whitelist

This article introduces the success of UK-based InnoCare in obtaining HSC common list white-listing from the EU Health and Safety Committee for their new COVID-19 antigen rapid test kit, with Pruvene providing full-process certification services. The demand for COVID-19 antigen self-test kits is gradually increasing in the EU market, but the requirements are becoming more stringent. As an international SaaS+Data medical device CRO, Pruvene can provide global market access consulting services for traditional medical devices, including overseas clinical trials, technical documentation preparation, regulatory consultation, product testing, customs clearance and logistics. In terms of certification services, Pruvene can provide enterprises with CE marking and technical documentation, helping them to smoothly obtain various certification certificates and enter overseas markets.

2021-11-25

"Pure Global Speeds Up" - MHRA Registration is Imminent, Pure Global Assists IVD Clients in Obtaining UK Registration Within One Week! (Verification Process)

This article introduces relevant information on medical device certification by the UK MHRA, including the certification process for non-COVID IVD products and COVID neutralizing antibodies, as well as Pruvene's professional certification services and regulatory consultation as an international medical device CRO. If you want to market your in vitro diagnostic products in the UK market, MHRA registration and verification are necessary processes, and the Pruvene team can provide efficient certification services for you.

2021-11-12

Success Story | Pure Global Assists Jinan Bobo Antigen Self-Test Kit in Obtaining Exemption Permit from French ANSM!

This article reports on the news that Jinan Bai Bo's COVID-19 antigen detection kit has obtained ANSM certification in France. This product has been granted exemption permission and can be sold in the French market before the issuance of the CE certificate. At the same time, this article also mentions the importance of the French Antigen self-test whitelist, as well as the difficulty and opportunities for self-test product whitelisting in the European market.

2021-10-25

[Congratulation] INDICAID® TheraQuick® COVID-19 Antigen Test Kit from Xiamen AmonMed Biotechnology Co., Ltd. (AmonMed) has received the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

INDICAID® Tuoxi® rapid antigen detection product, developed by Xiangda Biotech International Co., Ltd., has successfully obtained emergency use authorization (EUA) from the US FDA, becoming the first product in Greater China to receive the certificate. INDICAID® Tuoxi®'s unique sample preparation technology subverts traditional liquid biopsy extraction technology and brings breakthrough technological progress to the field of cancer liquid biopsy. As a company focusing on medical device certification and research and development, Xiangda Biotech is constantly pursuing originality and innovation in the medical field.

2021-09-01

Good news! Pure Global has helped their clients obtain the first IVDD self-test CE certificate after the issuance of the MDCG 2021-21 clinical new regulation!!

This article introduces a case of Pruvnene assisting clients in obtaining certification in overseas markets, including the certification requirements and methods for COVID-19 detection kits in the European market, as well as the current situation of the epidemic in Japan, Africa, and other regions. It also highlights Pruvene's rich experience and service scope in the international SaaS+Data medical device CRO field, such as overseas clinical trials, technical documentation preparation, regulatory consultation, product testing, customs clearance and logistics. Among them, Pruvene successfully helped clients submit CE application forms to the Polish testing center, and after a strict 5-week audit process, finally obtained the CE certificate. In addition, the article also mentions the three certification methods for COVID-19 detection kits in the European market, as well as the upcoming new regulation (IVDR) that will be enforced.

2021-08-19

Wanfu Biotechnology received the first POCT IVDR quality management system certificate in China.

Wanfu Biotechnology has become the first domestic manufacturer to obtain the IVDR quality management system certificate for POCT and the IVDR CE certification for NPT products, laying a foundation for sales in professional and bedside scenarios in the European market. The company's glycated hemoglobin test kit and C-reactive protein test kit have also received this certification, providing a positive impact on its business promotion in the EU region.

2021-08-17

Only three Chinese IVD companies have made it onto the FDA's whitelist - what are the methods behind this operation?

This article introduces the good news of Changsha Renji Medical Devices Co., Ltd.'s disposable sterile virus sampling tube PBS/saline transport media devices receiving FDA approval, and shares relevant certification knowledge of the product. At the same time, it introduces Pure Compliance as the first domestic Internet+ global medical device compliance qualification one-stop service provider for domestic medical device enterprises, providing one-stop certification services for their products. The article emphasizes the necessity of registration labeling and registration listing, and lists the FDA application process for PBS and VTM, while providing a way to contact Pure Compliance for better international export certification.

2021-07-20

Great news again! Pure Global has helped Litu Bio obtain temporary exemption for listing in France!

Pure Global has successfully assisted Zhuhai Litu Bio-Tech in obtaining temporary exemption for the French COVID-19 self-test rapid diagnostic kit to be listed on the market, enabling the product to be sold in France and providing strong support for France's epidemic prevention and control. Additionally, Prudence Certification can provide one-stop services for medical device certification, testing, export, and channel docking for multiple countries, such as FDA, CE, and COVID-19 self-test rapid diagnostic kit certification.

2021-07-17