Regulatory authorities around the world are continuously updating regulatory requirements to adapt to technological development and improve safety standards. For medical ultrasound gel, which are widely used medical consumables, the relevant regulations (such as classification rules, ingredient requirements, labeling requirements, clinical evaluation requirements, and post-market surveillance) may also change accordingly.
Brand owners and manufacturers must be able to understand and effectively respond to these regulatory updates in a timely manner to ensure ongoing compliance and avoid the risk of product delisting or penalties. Pingchuang Medical Group has established a proactive and systematic mechanism to respond to regulatory updates to ensure that its produced ultrasound gel products can maintain compliance without any worries.
Continuous monitoring of regulations is the first step in responding to updates. Pingchuang Medical has a professional regulatory affairs team, whose important responsibility is to maintain close attention to the regulatory dynamics of medical device regulations in major global markets (especially China's NMPA, the US FDA, and the EU MDR/IVDR) as well as key exporting countries. By subscribing to official notifications, participating in industry seminars, and collaborating with certification bodies and regulatory consulting companies, they strive to obtain the draft, final version, and related guidance documents of regulations as soon as possible.
Accurate interpretation and impact assessment are key steps. When a new regulatory requirement or standard update is released, the regulatory team will conduct in-depth research to accurately understand its connotation and scope of application, and assess its potential impact on existing ultrasound gel products, production processes, quality systems, technical documents, and labeling instructions, among others. For example, the EU MDR has raised higher requirements for the classification, clinical evaluation, and post-market surveillance of medical devices, and the regulatory team needs to assess whether the existing coupling agent products require adjustments in classification, additional clinical data, or enhanced post-market monitoring.
Based on the assessment results, initiate an internal change management process. If regulatory updates require adjustments, Pingchuang Medical will follow its change control procedures in accordance with the ISO 13485 standard, with relevant departments (research and development, production, quality, procurement, design, etc.) collaborating to develop and implement change plans. This may involve formula adjustments to meet new ingredient restrictions; process optimization to meet new production requirements; label updates to comply with new labeling regulations; additional testing or clinical data; updating technical documents and quality system files, etc. All changes must undergo thorough verification and risk assessment to ensure that the products and processes after the changes are still safe, effective, and compliant.
Maintain the validity of existing certifications. While making changes to respond to regulatory updates, Pingchuang Medical will ensure that these changes comply with the ISO 13485, FDA 510(k), CE, and other certifications held, and will promptly notify the relevant certification bodies or submit change applications when necessary to ensure the continuous validity of the certification certificates. This is the basis for the product to continue selling in the relevant markets.
Transparent communication with customers. When regulatory updates may affect the products currently being collaborated on by customers, Pingchuang Medical will actively communicate with customers to inform them of the content of the regulatory changes, potential impacts, and the company's planned response measures. Changes will be implemented after obtaining customer consent or joint discussion. This timely communication helps customers understand the situation, adjust their market strategies, and avoid losses caused by regulatory issues.
Continuous learning and external cooperation. The regulatory environment is constantly evolving, and Pingchuang Medical encourages the regulatory team to continuously learn and improve professional capabilities. When encountering complex or new regulatory issues, the company will also actively seek opinions and support from external top regulatory experts or institutions to ensure the accuracy and compliance of decisions.
For ultrasound gel brand manufacturers and distributors, regulatory risk is an important consideration in operations. Choosing a partner like Pingchuang Medical, which has the ability to actively, professionally, and systematically respond to regulatory updates, means that complex compliance matters can be entrusted with confidence.
