International Certifications for Professional Condom Manufacturing

At Songpu Latex, quality management and regulatory compliance are important parts of our condom manufacturing operations.

As a professional condom manufacturer in China, we maintain a quality management system and hold multiple international certifications covering medical device quality management, product conformity, environmental management and occupational health and safety.

These certifications provide our international customers with additional confidence when selecting Songpu Latex as an OEM and private label condom manufacturing partner.

Our current certification portfolio includes MDR CE, ISO 13485, ISO 9001, ISO 14001 and ISO 45001 certifications, subject to the scope and validity of each certificate.

Our International Certifications

MDR CE Certificate

Certification: MDR CE
Certification Body: TÜV

The MDR CE certification demonstrates conformity with applicable European medical device requirements within the scope stated on the relevant certificate.

For international condom brands and distributors serving European markets, regulatory compliance is an important part of supplier qualification.

Customers can contact our team to request the applicable certificate and confirm the relevant product scope, certificate validity and regulatory requirements for their market.

ISO 13485 – Medical Device Quality Management System

Certification: ISO 13485
Certification Body: Beijing Huaguang Certification of Medical Device Co., Ltd.

ISO 13485 is an internationally recognized quality management system standard specifically associated with medical devices.

For a condom manufacturer, an effective quality management system helps establish controlled processes for manufacturing, quality assurance, documentation, traceability and continual improvement.

Songpu Latex maintains ISO 13485 certification within the scope stated on the certificate.

For OEM customers, this certification is an important part of evaluating a manufacturer’s quality management capabilities.

ISO 9001 – Quality Management System

Certification: ISO 9001
Certification Body: Beijing Huaguang Certification of Medical Device Co., Ltd.

ISO 9001 is an internationally recognized quality management system standard.

For condom manufacturing, a structured quality management system supports consistent production processes, customer requirements management, corrective actions and continual improvement.

Our ISO 9001 certification reflects Songpu Latex’s commitment to maintaining a systematic approach to quality management.

ISO 14001 – Environmental Management System

Certification: ISO 14001
Certification Body: Beijing Zhonghua United Certification Co., Ltd.

ISO 14001 is an international standard for environmental management systems.

The standard provides a systematic framework for managing environmental responsibilities and improving environmental performance.

Songpu Latex’s ISO 14001 certification demonstrates our commitment to structured environmental management within our manufacturing operations.

ISO 45001 – Occupational Health & Safety Management System

Certification: ISO 45001
Certification Body: Beijing Zhonghua United Certification Co., Ltd.

ISO 45001 is an international standard for occupational health and safety management systems.

A structured occupational health and safety management system helps organizations identify workplace risks, improve safety management and create a safer working environment for employees.

Songpu Latex maintains ISO 45001 certification within the scope stated on the relevant certificate.

Why Certifications Matter When Choosing a Condom Manufacturer

For international condom brands, choosing an OEM manufacturer involves more than comparing product prices.

A qualified supplier should also demonstrate effective quality management, controlled manufacturing processes and the ability to provide appropriate documentation for the target market.

Our certifications help support supplier evaluation in areas such as:

• Quality management
• Medical device manufacturing
• Manufacturing process control
• Documentation and traceability
• Environmental management
• Occupational health and safety
• International B2B supplier qualification

However, certification alone does not replace product-specific testing or regulatory approval. The applicable requirements depend on the product, intended market and regulatory classification.

Quality Control in Condom Manufacturing

Certifications are only one part of our quality system.

Songpu Latex also operates dedicated quality inspection facilities and uses electronic testing and laboratory equipment as part of its manufacturing and inspection processes.

Our factory has multiple electronic testing lines, and our quality inspection center is equipped with physical, chemical and microbiological testing equipment.

Depending on the product and applicable requirements, testing may include areas such as:

• Electronic pinhole testing
• Water leakage testing
• Vacuum testing
• Bursting-related testing
• Physical performance testing
• Chemical testing
• Microbiological testing
• Packaging and labeling inspection

The specific tests and acceptance criteria depend on the product specification, applicable standard and target market.

ISO 4074 and Condom Quality Requirements

ISO 4074 is an important international standard for natural rubber latex male condoms. ISO officially published ISO 4074:2026 in March 2026, specifying requirements and test methods for male condoms made from natural rubber latex.

The standard covers requirements and test methods relevant to the quality and performance of natural rubber latex male condoms.

For OEM customers, the applicable standard and testing requirements should be confirmed according to the specific condom product and destination market.

Songpu Latex works with customers to identify the applicable product specifications, testing requirements and documentation needed for their projects.

Certifications for OEM & Private Label Condom Brands

If you are developing your own condom brand, certification and quality documentation can be an important part of supplier qualification.

Songpu Latex provides OEM and private label condom manufacturing services for:

• Condom brands
• Private label brands
• Importers
• Distributors
• Wholesalers
• Healthcare companies
• Pharmaceutical companies
• Retail brands
• E-commerce brands
• Sexual wellness companies

Before placing an OEM order, customers can discuss their target market, product specifications, applicable regulatory requirements and required documentation with our sales and quality teams.

Certification Documents for International Customers

We understand that international customers may need certification documents during supplier qualification, product registration or regulatory review.

Upon request and subject to applicable confidentiality and document-control requirements, we can provide relevant certification information for customer review.

Customers should confirm:

• Certificate number
• Certificate validity
• Certification body
• Certified company name
• Certified site
• Product or management-system scope
• Applicable market or regulatory requirements

This helps ensure that the certification information is correctly matched with the intended product and market.

A Quality-Focused Condom Manufacturing Partner

Songpu Latex combines professional condom manufacturing with structured quality management and international certification.

Our certifications include:

MDR CE
European medical device conformity within the applicable certificate scope

ISO 13485
Medical device quality management system

ISO 9001
Quality management system

ISO 14001
Environmental management system

ISO 45001
Occupational health and safety management system

Together with our manufacturing facilities, testing equipment and quality control procedures, these systems support our goal of providing reliable OEM and private label condom manufacturing for international customers.

Looking for a Certified Condom Manufacturer in China?

If you are looking for a certified condom manufacturer in China for your own brand, Songpu Latex can provide OEM and private label manufacturing solutions together with relevant certification and quality documentation.

Tell us your target market, condom type, packaging requirements and certification requirements.

Our team can help you identify the appropriate product specifications, quality documentation and manufacturing options for your project.

Contact Songpu Latex to discuss your OEM condom project.