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Packaging Manufacturer Management for Medical Device Companies Exporting to Japan
See all regulatory consulting services.
The Pharmaceutical Affairs Law (PAL) states that labeling, packaging and warehousing are “manufacturing” activities and therefore a Packaging Manufacturer License is required for anyone performing these tasks.
For medical devices exported to Japan, the Marketing Authorization Holder (MAH) clears products through Japanese Customs. This means that the product exported to Japan cannot be handled by the Packaging Manufacturer until the MAH releases the shipment.
Most manufacturers perform labeling and packaging at their foreign facility but some warehousing activity in Japan is still required. Emergo Japan K.K. can assist in the selection and management of your Packaging Manufacturer in Japan.
How we can help you select and manage your Packaging Manufacturer in Japan:
- Work with the Packaging Manufacturer to create a procedure for labeling, packaging and warehousing activities.
- Create a quality agreement between the Packaging Manufacturer and your MAH or D-MAH.
- Handle billing from the Packaging Manufacturer so you only need to pay one fee for all services.
Please contact us for more information on our packaging manufacturer management service for medical device companies exporting to Japan.
