English

Japanese

About DMJ

The Benefits of using DMJ as a
Marketing Authorization Holder?

  • No need to handle regulatory procedure in-house
    • Support will be provided by our parent company, Expartner Japan Co., Ltd.
  • Dealing both as DMAH and MAH ！
    • Dealing both as DMAH and MAH ！
  • Cost structure tailored to your needs！
    • Cost structure tailored to your needs！
  • English communication for overseas manufacturers is also available！
    • We also handle product change management and defective product support in English.
  • Contract period starts from 1 year！
    • After one year, the license (MAH) or (DMAH) can be transferred to your company upon request.

MAH/ DMAH Positioning

Fee

Fixed monthly fee (license fee) system
Our marketing authorization holder fee system is based on a fixed monthly license fee.

Work Flow

We will explain the process from consultation to
the start of sales in the case of new applications
and DMAH succession.

MAH Product Handling records Example

  • ECG monitor (USA) Class II
  • Multiparameter monitor (China) Class II
  • Multiparameter monitor (China) Class II
  • Electronic stethoscope (South Korea) Class II
  • Dental implant system (South Korea) Class III
  • Single-use injection needle (South Korea) Class II
  • Single-use blunt-end irrigation/injection needle (South Korea) Class II
  • Radiopharmaceutical synthesis equipment (Belgium) Class III
  • Dental implant abutment (South Korea) Class III
  • Hard resin for dental crowns (South Korea) Class II
  • Video flexible cystoscope (Denmark) Class II
  • Vacuum-sealed blood collection tube (China) Class II
  • Acrylic resin for denture base (South Korea) Class II
  • Needle for pharmaceuticals and vaccine injection (China) Class II
  • Dental ceramic for cutting and shaping (South Korea) Class II
  • Total hip joint prosthesis (South Korea) Class III
  • Superstructure material for dental implants (South Korea) Class II
  • Human amniotic membrane for tissue healing (USA) Class IV
  • Injectable material for vesicoureteral reflux treatment (USA) Class III
  • Single-use endoscopic injection needle (USA) Class II