Success Stories

global growth partner to MedTech companies

Pure Global supports Mindray Biomedical in obtaining IVDR registration, congratulations on Mindray's Q1 profit exceeding 1.3 billion!

Mingde Biotech has completed the product registration under the new IVDR regulations ahead of schedule, which means the company can fully prepare and comply with the new regulations by May 26, 2022. Full compliance with the IVDR regulations is a huge challenge for manufacturers, and Mingde Biotech, as an excellent IVD manufacturer, has demonstrated the professionalism and foresight of its team. This registration has obtained qualification certificates for four products: Disposable Virus Sampling Tube, Sample Release Reagent, Full-Automatic Nucleic Acid Extraction and Purification Instrument, and Nucleic Acid (DNA/RNA) Extraction Kit.

2022-04-14

Great news! In the beginning of this month, with the help of Pure Global

The article introduces the story of how the Pure Global team helped a well-known domestic enterprise successfully pass the FDA Class II OTC product certification for its home beauty device products. The article explains the concepts of FDA certification and the 510(k) pathway and emphasizes the impact of certification for home beauty device products on consumer psychology. Pure Global provides professional full-process services to help medical device companies complete various certification qualifications and obtain relevant certificate certification reports, laying a solid foundation for their entry into international markets.

2022-03-23

COVID-19 Self-Test | Pure Global Helps Leading Domestic Manufacturer Obtain Saudi MDMA Certification Again!

Pure Global helped top domestic enterprise customers' new coronavirus test kits and COVID-19 antigen rapid self-test kits obtain MDMA certification and medical device market approval in Saudi Arabia, helping to expand overseas markets and enhance product competitiveness. The SFDA's review of MDMA applications is very strict, but Pure Global has an experienced team of experts and high-level business capabilities to provide full consultation services and assist in handling all issues in the SFDA registration process. Welcome to contact Pure Global services for more information on medical device certification.

2022-03-10

Success Story | Pure Global Helps Leading IVD Enterprise in China Obtain TFDA Approval, Opening the Door to the Thai Market for COVID-19 Test Kits!

The article introduces the process of how a top domestic IVD enterprise client's new coronavirus test kit product was registered with the Thai Food and Drug Administration and successfully entered the Thai market. The article also introduces the demand and certification process of the medical device market in Thailand, as well as the TFDA registration services that Pure Global 's global expert team can provide. This is a good opportunity for IVD manufacturers who want to enter the Southeast Asian market.

2022-02-22

Pure Global | CE Certification Acceptance Letter for A List High-Risk IVD Products under IVDD Obtained!

The article introduces how the Pure Global team helped the domestic hepatitis B virus (HBV) test kit obtain CE certification under the IVDD and undergo List A conformity assessment. The article also introduces the product classification and corresponding certification procedures under the IVDD directive, including national registration and NB certificate issuance. The article details the content of conformity assessment and the preparation of technical documents, as well as the professional services provided by the Pure Global team.

2022-01-26

Pure Global 's Speed! A Top Domestic Enterprise Completes IVDR CE Registration with PurFDA's Help in Just One Week!

With the implementation date of IVDR on May 26, 2022 fast approaching, manufacturers have started preparations for obtaining the CE certificate under the new IVDR regulation. IVDR will be divided into four categories, with in-vitro diagnostic reagents requiring certification by a third-party notified body. Manufacturers should determine the classification of their products under IVDR and initiate relevant processing work as early as possible. The good news is that Pure Global has helped domestic clients complete IVDR CE registration, which is sure to be a shot in the arm for the industry.

2022-01-21

Exciting News! Pure Global Helps Top Domestic Enterprises Register with MDMA and Open the Door to the Saudi Market!

This article introduces the success of the Pure Global team in helping a leading domestic enterprise obtain sales qualification for IVD testing products in Saudi Arabia, which requires strict approval from SFDA certification. The certification requires consideration of local license holder models, registration requirements, and the appointment of authorized agents in Saudi Arabia. In addition, products need to meet the certification requirements of the US, Japan, Australia, Canada, or Europe to be approved and listed in Saudi Arabia. With an experienced team of experts and high-level business capabilities, Pure Global can assist you in handling all issues related to medical device registration and provide high-quality and efficient end-to-end services.

2022-01-18

Another Victory | Pure Global helps customers obtain two CE certificate acceptance letters for COVID-19 antigen detection kits within 10 days!

The article mainly introduces the case of Pure Global assisting in obtaining CE certification for in-vitro diagnostic manufacturers, including COVID-19 antigen detection test products, in a short period of time. With IVDD set to expire in May 2022, manufacturers need to obtain certification from this new NB as soon as possible to meet the requirements for legal sales in the EU market. With its professionalism and clinical capabilities, the Pure Global team provided fast and end-to-end services, helping clients obtain CE certification in a short time and gaining recognition and praise in the market.

2022-01-13

Success Story | Pure Global assists a customer in obtaining a CE certificate acceptance letter for a COVID-19 antigen detection kit

The Pure Global team helped domestic clients obtain the CE certificate in the shortest possible time, demonstrating their professionalism and market acumen. With the implementation of the IVDR regulation, manufacturers need to obtain certification as soon as possible to enter the international market. As a reliable partner, Pure Global will help clients achieve compliance in overseas markets.

2022-01-12