Japan & Korea：Medical Device Regulatory Support Expertise

Japan PMDA Manufacturer Registration & Korea KGMP Expertise

Last Updated: 2025-04-18

▮ Japan PMDA Compliance

1. Redgistration Certificate of Foreign Medical Device Manufacturer

◼ **Registration No.**: BG10502126  
◼ **Holder**: Huizhou Jinghao Medical Technology Co., Ltd.  
◼ **Facility Address**: No.207, South Silluan Rd, Zhongkai Hi-Tech District, Huizhou, China  
◼ **Validity**: August 16, 2023 - August 15, 2026  
◼ **Legal Basis**: Article 23-2-4 of Japan's Pharmaceuticals and Medical Devices Act  

**Key Compliance Features**:  
✅ Approved manufacturing facility for Japanese market entry  
✅ Prerequisite for Class I-IV device submissions  
✅ Renewable every 3 years with ongoing GMP compliance

2. Registration vs Product Certification
"While our PMDA Manufacturer Registration (BG10502126) establishes your production facility's eligibility, **Class-specific device certification** requires..."

▮ Korea MFDS/KGMP Support

1. Client Certification Assistance

◼ **Certificate Type**: 의료기기 제조 및 품질관리 기준 적합인정서 (GMP Compliance Certification)  
◼ **Product Category**: Hearing Aids (보청기)  
◼ **Certification Body**: Korea Testing & Research Institute (KTR)  
◼ **Validity**: 2024-02-07 to 2027-02-06  
◼ **Facility Location**: Huizhou, Guangdong, China (MFDS-registered site)  

2. Certification Value Chain

▮ Client Success Stories
Our team has successfully guided two medical device manufacturers through the complete KGMP certification process with the Korea MFDS. The redacted certificate sample displayed above represents one of these successful client engagements

“Both successful KGMP certifications involved **hearing aid manufacturers**, demonstrating our specialization in…”

▮ Why Partner With Us?

With direct experience in securing PMDA Manufacturer Registration (BG10502126) and KGMP certifications for hearing aid innovators, we offer more than compliance – we deliver market-ready confidence.