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
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
Tablet Hardness Tester
Tablet Friability Tester
Disintegration Tester
Compliance Documents Available:
- CE certificate for each instrument category (dissolution, hardness, friability, disintegration)
- EMC Technical File (EN IEC 61326-1)
- Technical Construction File (Machinery Directive)
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
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.
Documentation on Request
CE certificates, the Technical Construction File and the EMC Technical File are available on request for equipment qualification.
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 →Quarterly Technical Newsletter
Pharmacopeia updates, QC testing notes and ODF application cases — once a quarter.