외국기업 국내대리인 서비스

메디팁은 한국에서 의약품 및 의료기기의 제품허가 및 보험보상인정범위를 직접 결정하려는 의료관련 외국업체 또는 수입업체에게 Product license maintenance (외국기업 국내 대리인) 서비스를 제공함으로써 지속적이고 안정적인 제품을 공급할 수 있도록 돕겠습니다. 저희의 외국기업 국내대리인 서비스는 고객의 국내 컨설턴트로서 품목허가 및 GMP 유지와 보험책정의 주체로, 고객의 의사를 반영하는데 중점을 두고 있습니다.

  • Host regulatory approvals
  • Host reimbursement price
  • Post market Follow-ups and government correspondences

Detailed responsibilities in connection with the Services and Communication

Description Responsible Party
A I Basic requirements
a)
b)
c)
d)
e)
Hiring a quality management representative for imported
Imported Products
Testing facilities
Handling of imports product licenses gained already.
Report of total imported quantities every year to MFDS
Observe the medical device affairs law .
MEDITIP
MEDITIP&CLIENT
MEDITIP
MEDITIP
MEDITIP
B I Quality Management
a)

b)
c)
d)
e)




f)
Quality Testing : Conducting of Product quality testing by internal or external laboratory / Informing of the test result to CLIENT.
Make payments directly to external laboratory for Quality testing for every shipments (if applicable).
Control of Non Conforming Product: review & disposition of nonconforming product.
Employees re-training.
Documents control.
- Document issue
- Record
- Traceability
- Document change & Modification
Extra warehousing fee: if applicable
MEDITIP &CLIENT

CLIENT
Local Distributor
MEDITIP &CLIENT
MEDITIP&CLIENT




CLIENT or Local Distributor
II Audit
a)
b)
c)
Internal audit
Irregular MFDS audit
Site Inspection by MFDS, if applicable
MEDITIP&CLIENT
MEDITIP
MEDITIP&CLIENT
III Labeling in Korean version
a)
b)
c)
Labeling design
Labeling printing
QC check on the every lot imported product
CLIENT
CLIENT
CLIENT
C a)
b)
c)
Provide product information to MEDITIP prior to importation(model,Lot no., quantity,
etc.) before each shipment
Pre- notification to MFDS and custom clearance Education on relevant laws and regulations for CLIENT regarding distributor’s responsibilities & duties
CLIENT
MEDITIP
MEDITIP
D I Actual Custom Clearance
a)
b)
c)
Forward all documents for customs clearance to forwarding company.
Delivery, custody or pick-up the imported products to a warehouse.
Make payments directly to forwarding Meditip involved in duties, delivery, handling charge, etc.
CLIENT/Local distributor
CLIENT/Local distributor
CLIENT/Local distributor
E a) Start shipping and send related documents to Client and Meditip Local distributor
F I Claim/Complaint Handling & Product related reporting to MFDS

Responsibility party for Claims/ Complaint Handing & Safety reporting to MFDS

1. Claim/Complaint Handing from Customers
Meditip Consulting Scope
2. Product related reporting to MFDS
  • 2.1 Product related reporting includes
    • Irregular safety reporting to MFDS
    • Reporting in connection with product recall
  • 2.2 Responsibilities
    MEDITIP CLIENT
    Report to MFDS under the name of ‘MEDITIP’ - Request MEDITIP of reporting by written agreement
    - Provide MEDITIP with information to be reported to MFDS
    - All necessary and corrective actions related to the reported subject.