top of page

Richter Rubber Technology

Lab testing and research


CE Approved

CE marking signifies that a product complies with European Union (EU) safety, health, and environmental protection directives and regulations. It is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA), acting as a declaration from the manufacturer that the product meets all the appropriate provisions of the relevant EU legislation.

FDA Approved

FDA approval is a regulatory process by the U.S. Food and Drug Administration, ensuring that a product, such as a new drug or medical device, meets the agency's rigorous safety and efficacy standards.


SMETA (Sedex Members Ethical Trade Audit) certification is a comprehensive ethical audit framework that assesses social and ethical performance in supply chains. It provides a standardized method for companies to evaluate and communicate responsible business practices, covering areas such as labor, health and safety, environmental impact, and business ethics.

ISO Standards
- 13485

ISO 13485 sets requirements for quality management systems in the design and manufacturing of medical devices to ensure compliance with regulatory standards, while ISO 14001 outlines criteria for implementing environmental management systems, assisting organizations in adopting sustainable practices and reducing environmental impact.

Medical Device Authority
Malaysia (MDA)

The Medical Device Authority (MDA) approval in Malaysia is a regulatory requirement ensuring that medical devices adhere to safety and efficacy standards.

This approval is essential for companies intending to market and distribute medical devices in Malaysia, indicating compliance with the country's regulatory framework.

(Formerly known as CCC)

The Chinese FDA approval, formerly known as China Compulsory Certification (CCC), is a regulatory process ensuring that products entering the Chinese market comply with safety and quality standards. It is a mandatory certification for various products, emphasizing adherence to specific requirements and regulations to ensure consumer safety.

bottom of page