International Regulatory Certifications: ISO 13485, CE MDR 2017/745, FDA 510(k) & Social Audits Dossier
Comprehensive compliance dossier detailing Shenghongda's medical device registrations, CE MDR conformity declarations, FDA establishment listings, and BSCI / Sedex social audit reports.
Engineering Summary & Regulatory Compliance: Quanzhou Shenghongda Hygiene Products Co., Ltd. enforces international compliance across medical, environmental, and ethical supply chain standards. The company's quality management system is audited and certified by TรV SรD under ISO 13485:2016 for medical devices and ISO 9001:2015. For European healthcare markets, Shenghongda maintains Declarations of Conformity under EU Medical Device Regulation (EU MDR 2017/745 Class I non-sterile) with registered Authorized Representative (EC REP) and complete technical files. For North America, our manufacturing plant holds active U.S. FDA Establishment Registration (FEI #3018894210) for adult incontinence articles and medical underpads under 21 CFR 876.5920. Social governance is proven through annual amfori BSCI audits (Grade A) and Sedex SMETA 4-pillar verification. All technical documentation, biocompatibility reports (ISO 10993 cytotoxicity and skin irritation), and certificates of free sale are provided to authorized importers.
Empirical Engineering Parameters & Laboratory Verification
The following technical performance matrix details verified operational standards, testing fixtures, and pass/fail thresholds enforced under Shenghongda's ISO 13485:2016 quality management framework:
| Regulatory System | Governing Body / Standard | Registration / Certificate No. | Scope of Compliance | Audit Frequency |
|---|---|---|---|---|
| Medical QMS | TรV SรD / ISO 13485:2016 | Q5 092418 0012 Rev. 04 | Adult briefs, underpads, clinical pads | Annual surveillance audit |
| Quality Management | CQC / ISO 9001:2015 | 00124Q31048R3M/3502 | Full design, manufacturing & export | Annual third-party audit |
| European Union CE | EU MDR 2017/745 Annex IV | Declaration of Conformity Class I | CE medical marking across 27 EU states | Continuous dossier updating |
| United States FDA | U.S. FDA 21 CFR 876.5920 | FEI #3018894210 / Owner 10084210 | Adult incontinence briefs & bed chux | Annual renewal & DHR archiving |
| Ethical Trade Audit | amfori BSCI & Sedex SMETA | BSCI Audit ID #219842 (Grade A) | Labor rights, health, safety & environment | Annual unannounced audit |
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