——Sinocare Helps to Set IndustryStandards, and Boost Medical Device Development in China

Standard comes before quality improvement. In recent years, quality improvement movements have been constantly introduced in industrial development, while industrial standards have been continuously updated and evolved. Standards are the technical support for economic activities and social development. In the new era, required by high-quality development, it is urgent to strengthen standardization to further upgrade industries.

In October 2021, SAC/TC 136 officially released GB/T19634-2021 In vitro diagnostic test systems - General technical requirements forblood glucose monitoring systems for self-testing, which regulates terms and definitions, requirements, test methods, labels and instructions, packaging, transportation and storage ofblood glucose monitoring system for self-testing, listquality indicators and safety requirements ofblood glucose products for self-testing, and becomes a new standard applicable to the industrial development.

In general, industrial leaders set the standard. As one ofthe standard drafters and the first glucometer company in China to go public, Sinocare took the lead in setting the new standard based on the overall industrial development situation in China and backed by experimental data.

Focus on Domestic Conditions and Set Standards with Solid Data

Along with industrial development and technical progress ofblood glucose related industry, performance indicators also improved. As international standards regardingblood glucose gradually update, the 1st version of blood glucose standard released in 2005 in China no longer applies to the current industrial development.

In 2019, to break down industry barriers and facilitate industrial development and upgrading, SAC/TC 136 publicly invited drafters to participate in standard drafting and revising, to set a higher bar for in vitro diagnosticblood glucose monitoring industry, for the complete replacement of GB/ T19634-2005 In vitro diagnostic testsystem - General technical requirements forblood glucose monitoring systems for self-testing. “We responded immediately, applied to participate in standard-setting, and formed a team”, according to Zhou Qian, registration regulation director of Sinocare.

After more than 10 years of development, as China’s leadingblood glucose monitoring company, Sinocare owns an extremely diversified product lineup, including trace and fastblood glucose monitoring system for home and medical blood glucose monitoring. In China, more than 50% of those who self-monitor diabetes use Sinocare’s chronic disease multi-indicator detection products, glucometer users exceeded 18 million, and Sinocare’s products are sold in 220,000 pharmacies.

On that basis, while setting the standard, as an experienced industry player, Sinocare has its own advantages and insightsinto the industry.

Zhou Qian introduced that in drafting the standards, the importedbrands put forward higher precision requirements. “Currently, most Chinese brands cannot meet such technical requirements, and setting the bar too high is not conducive to domestic industrial development.” Zhou Qian pointed out that an industry standard should be generally applicable to guide and drivethe domestic industry forward.

“At present, neither the EU’s EN ISO15197 nor the US’s FDA guidelines on blood glucose specified an acceptable standard of blood glucose precision,” said Zhou Qian. By comparing tons of experimental test data and discussing with members of the standard committee, the final decision was to not raisethe precisionstandards, which helped to win more market share for Chinese brands.

It is reported that GB/T19634-2021 In vitro diagnostic test systems - General technical requirements forblood glucose monitoring systems for self-testing was released in 2021, and will be formally implemented in 2023. Considering people’s health standards and thepromotion of innovation in medical devices, the national mandatory standard originally set in the document has been turned into anationally recommended standard. As a threshold for entry into the industry, the introduction of this standard will inevitably prompt enterprises to improve technology, product performance, and quality, and provide better products and services for diabetics.

Build a Team to Overcome Obstacles and Lead Industrial Development

“Standard-setting tests both our capacities and energy.” As Sinocare’s team leader, Zhou Qian has more to say.

“At first, our team was not so experienced in setting standards, we moved forward steadily through trial and error,” Zhou Qian recalled. In the initial stage, the work was complicated and required repeated verification of product indicators and requirements. Our team has to read a lot of materials to solve problems in the project one after another.” Members of the R&D, test, and registration teams were either in the lab or in front of the computer, and it’s not uncommon to stay up late and work overtime.”

Sinocare team developed strong basic skills through loads of preliminary work. In 2020, Sinocare became an observer of SAC/TC 136,and is responsible for leading and setting a series of industry-related standards.

From the kick-off meeting to the seminar, the whole standard-setting process took more than one year. Through repeated experiments and deliberation in pursuit of rigorous data,the Sinocare team’s performance was outstanding and contributed the most to the standard-setting.

“Setting a national standard requires repeated trials by a team to ensure that it applies to most companies and is not biased,” said Zhou Qian, “During this process, our team honed and improved our professional abilities.”

“In fact,China wants to support domestic brands and guide industrial development by setting the standard,” Zhou Qian said. Sinocare feels honored and encouraged to be part of it. She added: “Apart from ourowndevelopment, we should also pay close attention to what is happening in the industry, and contribute to industrial development and human health.”

Caring for Love, Build Chinese Brand

On December 28, 2021, the 9 newly registered products of Sinocare’s “Carbon HPALC Blood Glucose Testing System” project were approved by Hunan Medical Products Administration. This series of products meet the requirements of the new national standard for blood glucose (GB/T19634-2021 In vitro diagnostic test systems - General technical requirements forblood glucose monitoring systems for self-testing). They further expand the categories and specifications of Sinocare products in domestic and international retail markets, professional markets, etc., and effectively complement Sinocare’s existing blood glucose testing products, helping to meet various testing needs of the market.

Zhou Qian mentioned: “Actually, most of our products meet international standards.” Since it was founded in 2002, Sinocare has been committed to the R&D ofglucometers with independent intellectual property rights, aiming to make cost-effectiveglucometers and teststrips available for Chinese people.

Looking back on its development, it’s noticeable that as the main drafter of the standard, Sinocare not only demonstrates strong R&D capabilities in the field of blood sugar monitoring, but also enjoys a large share and good reputation in the market.

Sinocare’s registered product categories in blood glucose monitoring and chronic disease detection have been gradually expanded from the retail market to hospitals, community-level medical care institutions, and overseasmarkets. Meanwhile, it actively responds to policies regarding China’s hierarchical medical treatment and chronic disease management, to keep and increase the coverage of Sinocare products and services by making full use of its multi-indicator detection system, minute clinic, and in-hospital blood glucose management system. Currently, Sinocare hasa presence in 135 countries and regions around the world and has become a global leader in the detection of diabetes and relevant chronic diseases.

“Love yourself, love your family, and love others” has always been Sinocare’s corporate culture and solemn commitment to society. Walking into the hall of Sinocare’s office located in Changsha High & New Technology Industrial Development Zone, a huge sculpture composed of three red hearts attracts attention. Sinocare Chairman Li Shaobo introduced that, as an enterprise dedicated to diabetes management enterprise, Sinocare upholds its original mission and is committed to helping diabetes to understand and master thecomprehensive diabetes management.

“We want to grow together with more Chinese enterprises, andcontribute to Healthy China Initiative, while building anall-around trust system of quality, service, etc, to co-develop trustworthy Chinese brands.” Mr. Li’s words are powerful.