Certification Standards for Adult Care Products Across Different Countries (e.g., CE, FDA, ISO)

Driven by the acceleration of global aging and the upgrading of health consumption, the market for adult care products such as diapers and nursing pads is experiencing explosive growth. However, regulatory requirements for these products vary significantly across different countries and regions, necessitating that companies establish a multi-dimensional certification system to break through market barriers. This article systematically reviews the three core certification standards—the US FDA, the EU CE, and international ISO—to provide suppliers with a compliance guide for global布局.

US FDA Certification: A Benchmark Practice for Medical-Grade Safety Thresholds

As the world's most stringent regulatory system for medical products, the US FDA classifies adult care products as Class I medical devices, implementing a dual-track management system of "registration + listing." Its certification core comprises three key dimensions:

Risk-Based Classification Management

Based on the degree of risk associated with human contact, the FDA categorizes adult diapers as Class I low-risk products, exempting them from 510(k) premarket notification but requiring establishment registration and device listing. Companies must submit a Facility Establishment Identifier (FEI) code and technical documentation to demonstrate compliance with 21 CFR Part 820 Quality System Regulation (QSR 820).

Full Lifecycle Traceability

Products are required to have a Unique Device Identification (UDI) on their labels, encompassing a Device Identifier (DI) and Production Identifier (PI). For example, an international brand achieved full supply chain traceability from raw materials to end-users by embedding NFC chips, meeting the FDA's mandatory traceability requirements for medical devices.

Dynamic Fee Mechanism

FDA registration requires an annual establishment registration fee, set at 9,280forthe2025fiscalyear.CompaniesmustrenewtheirregistrationbetweenOctober1andDecember31eachyear,withfailureresultingincustomsclearancedelays.AChinesesupplieronceincurredlossesexceeding150,000 when $2 million worth of goods were held at the Port of Los Angeles due to expired registration.

EU CE Certification: A Dual Challenge of Technical Regulations and Market Access

The EU has established the world's most complex medical device regulatory framework through the Medical Device Regulation (MDR 2017/745). Adult care products must pass the following seven certification stages:

Technical Documentation (TCF) Compilation

Core documents include biocompatibility test reports (ISO 10993-1), risk analysis reports (ISO 14971), and clinical evaluation reports (if applicable). A German company invested €500,000 to build an MDR-compliant laboratory, completing 12 performance tests and three rounds of simulated audits to achieve CE certification.

Unique Device Identification (UDI) System

Products must display a Basic UDI-DI and a Single Registration Number (SRN), with registration via the EUDAMED database. A Japanese brand faced a €120,000 fine and product re-labeling after 30,000 items were detained by EU customs due to UDI coding errors.

Appointment of an Authorized Representative (EC REP)

Non-EU companies must appoint an EU-based authorized representative responsible for compliance oversight and regulatory communication. A Chinese manufacturer was fined €80,000 and had product sales suspended for six months by French regulators for failing to appoint an EC REP.

ISO Certification: The Universal Language of Global Quality Management

ISO standards provide a cross-regional quality management framework for adult care products, with ISO 13485 (Medical Device Quality Management Systems) and ISO 9001 (General Quality Management Systems) forming the dual certification core:

ISO 13485: Medical-Grade Quality Control

Requires companies to establish a management system covering design, production control, and adverse event monitoring. A Korean company reduced its product defect rate from 1.2% to 0.3% after achieving ISO 13485 certification, successfully entering the German premium elderly care market.

ISO 9001: Supply Chain Efficiency Enhancement

Focuses on continuous improvement and customer satisfaction, helping optimize production processes. A Chinese factory shortened order delivery cycles by 25%, improved inventory turnover by 40%, and saved over RMB 3 million in annual operating costs after implementing ISO 9001.

Synergistic Certification Effects

ISO certification can streamline certification processes in some countries. For example, companies with ISO 13485 certification can skip certain on-site audits when applying for Saudi Arabia's MDMA certification, reducing certification cycles by 30%.

Multi-Country Certification Strategy: Balancing Time and Cost

Faced with varying certification requirements across markets, companies need differentiated strategies:

Rapid Market Entry

Fast-track approval models in the EU, US, and other markets enable certification within 1–4 weeks. A Chinese brand achieved quarterly sales exceeding $5 million by prioritizing CE certification and completing registrations in 12 countries within three months.

Long-Cycle Market Preparation

Saudi Arabia's MDMA certification takes up to 60 days and requires concurrent ISO 13485 certification. One company initiated the certification process six months ahead of product launch to avoid missing market opportunities.

Cost Optimization

Choosing International Accreditation Forum (IAF)-recognized certification bodies reduces redundant certification costs. A company saved over RMB 200,000 annually by obtaining ISO certification through an IAF-accredited agency, with its certificates recognized in 56 economies.

Future Trends: New Dimensions in Smart and Sustainable Certification

As technology evolves and environmental requirements rise, certification standards are evolving in two key directions:

Smart Care Product Certification

The EU is developing EMC (Electromagnetic Compatibility) and cybersecurity standards for smart diapers, requiring data encryption and privacy protection. A brand has launched smart diapers with urine volume monitoring sensors, whose data transmission modules have passed EN 301 489-1 certification.

Sustainability Certification Systems

ISO 14021 environmental labeling standards mandate disclosure of biodegradable material content and carbon footprint data. A company developed biodegradable nursing pads using bio-based materials, achieving a 35% carbon reduction according to its Life Cycle Assessment (LCA) report, and obtaining the Nordic Swan Ecolabel certification.

With the global adult care market growing at a compound annual rate of 6.8%, establishing a multi-dimensional certification system has become a core competitive advantage for companies seeking to break through market barriers. By deeply understanding the technical requirements and compliance points of standards such as FDA, CE, and ISO, suppliers can not only meet current regulatory demands but also proactively布局 (strategically position themselves) in smart care and sustainable product sectors, gaining an edge in global competition.