Certifications & Compliance | Huanghai Pharmaceutical Instruments
Certifications & Compliance
EU Regulatory Conformity Documentation — Huanghai Pharmaceutical Instruments
Huanghai pharmaceutical tablet testing instruments are CE certified under both the EU Machinery Directive (2006/42/EC) and the Electromagnetic Compatibility Directive (2014/30/EU). Compliance documentation is available for equipment qualification purposes.
4 Product Categories — All CE Certified
Directives
2006/42/EC · 2014/30/EU
EMC Test Lab
Shanghai Global Testing Services (GTS)
Applicable Standards:
- 2006/42/EC Machinery Directive — EN ISO 12100:2010 · EN 60204-1:2018 · EN 61010-1:2010+A1:2019
- 2014/30/EU EMC Directive — EN IEC 61326-1:2021
Models Covered by Instrument Type:
Dissolution Tester
Cert. M.2026.206.C139011Tablet Hardness Tester
Cert. M.2025.206.C114824Tablet Friability Tester
Cert. M.2025.206.C114821Disintegration Tester
Cert. M.2025.206.C114825Compliance Documents Available:
- CE Certificate M.2026.206.C139011 — Dissolution Tester
- CE Certificate M.2025.206.C114824 — Tablet Hardness Tester
- CE Certificate M.2025.206.C114821 — Tablet Friability Tester
- CE Certificate M.2025.206.C114825 — Disintegration Tester
- EMC Technical File — Report No. TESH26040284865
- Technical Construction File — MD-TCF-260402-84864 (Machinery Directive TCF)
Documents are available upon request for qualification and procurement purposes. Contact our technical team →
ISO 9001:2015 Certified
Standard
GB/T 19001-2016 / ISO 9001:2015
Certification Body
CCCI Huaxia Certification Center
Accreditation
CNAS C021-M · IAF Member
Certificate Scope:
Manufacture of pharmaceutical equipment and drug control instruments — covering the full production and quality control process for all Huanghai pharmaceutical testing instruments.
What Our CE Certification Covers
Machinery Directive 2006/42/EC
Mechanical and electrical safety assessment per EN ISO 12100 and EN 60204-1. Complete Technical Construction File maintained and available to EU market surveillance authorities.
EMC Directive 2014/30/EU
Full emission and immunity testing per EN IEC 61326-1:2021 — confirming data integrity in electrically noisy laboratory environments.
Independent Third-Party Attestation
Technical files independently audited by an accredited certification body, providing assurance beyond manufacturer self-declaration.
GMP Equipment Qualification Support
For laboratories conducting IQ/OQ/PQ qualification under EU GMP Annex 15, Huanghai provides the complete CE documentation package — directly applicable to Design Qualification (DQ) and Installation Qualification (IQ) phases.
Request Compliance Documentation
CE certificates, EMC test reports, and technical file summaries available for qualified customers.
Contact Our Technical Team →Free: 21 CFR Part 11 Validation Pack + QC Lab Setup Checklist
Compliance templates for ODF / pharma testing equipment + quarterly technical newsletter.