
Richter Rubber Technology

CERTIFICATIONS


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
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
-14001
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.
.png)
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.

CFDA
(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.

SGS Approved
MDR (EU) 2017/745
MDR (EU) 2017/745 sets requirements for quality management systems and regulatory compliance in the manufacture of medical devices. It ensures products meet strict European Union standards for safety, performance, and quality, reinforcing our commitment to delivering reliable medical solutions.

BSI Approved
MDSAP is a globally recognized audit program that enables medical device manufacturers to demonstrate compliance with the regulatory requirements of multiple countries, including Australia, Brazil, Canada, Japan, and the United States. This certification reflects our commitment to maintaining the highest standards of quality, safety, and regulatory compliance in the design, development, and manufacture of medical devices.

TÜVNORD Approved
ISO 14001:2015 / MS ISO 14001:2015
Certified by TÜVNORD, ISO 14001:2015 specifies the requirements for an Environmental Management System (EMS), helping organizations improve environmental performance, reduce waste, and ensure compliance with environmental regulations. This certification reflects our commitment to sustainable operations, environmental responsibility, and continuous improvement.