Hello. If you are a subcontract manufacturer, is it the customers/legal manufacturers responsibility to obtain and maintain a foreign manufacturers establishment registration? How does it work if more than one customer/legal manufacturer wants to sell in Japan, as sites only appear to have one registration number? Thanks
Establishment registration for subcontractors
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Orca1
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In Japan, foreign manufacturers intending to manufacture medical devices or drugs and export them to Japan are required to be accredited by the Minister of Health, Labour, and Welfare as an "Accredited Foreign Manufacturer". This accreditation is granted for each manufacturing establishment according to the category specified by the Enforcement Regulations.
The application for accreditation can be made by the foreign manufacturer or a Japanese marketing approval holder who markets drugs etc. manufactured by a foreign manufacturer can make an accreditation application on the manufacturer’s behalf. However, the space of “Name of Applicant” on the application form should be filled out with the foreign manufacturer’s name.
If a foreign manufacturer intends to manufacture only drug substances to be exported to Japan, they also need to obtain accreditation as an "Accredited Foreign Manufacturer".
When an "Accredited Foreign Manufacturer" changes the category accredited to their manufacturing establishment or adds new categories to their accreditation, they must submit a form, “Application for Change/Addition” (Form No. 21 specified in the PAL Enforcement Regulations), in order to newly obtain the Minister’s accreditation for the change or addition.
If more than one customer/legal manufacturer wants to sell in Japan, each manufacturer would need to apply for their own accreditation. The accreditation is granted for each manufacturing establishment according to the category specified by the Enforcement Regulations. Therefore, each manufacturer would have their own accreditation number.
In the case of a subcontract manufacturer, it would be the responsibility of the legal manufacturer to obtain and maintain the foreign manufacturer's establishment registration. The subcontract manufacturer would need to comply with the quality and manufacturing standards set by the legal manufacturer and the regulatory authorities.
For reference, see:
PMDA (Japan): Explanation of Application for Accreditation of Foreign Manufacturers
The application for accreditation can be made by the foreign manufacturer or a Japanese marketing approval holder who markets drugs etc. manufactured by a foreign manufacturer can make an accreditation application on the manufacturer’s behalf. However, the space of “Name of Applicant” on the application form should be filled out with the foreign manufacturer’s name.
If a foreign manufacturer intends to manufacture only drug substances to be exported to Japan, they also need to obtain accreditation as an "Accredited Foreign Manufacturer".
When an "Accredited Foreign Manufacturer" changes the category accredited to their manufacturing establishment or adds new categories to their accreditation, they must submit a form, “Application for Change/Addition” (Form No. 21 specified in the PAL Enforcement Regulations), in order to newly obtain the Minister’s accreditation for the change or addition.
If more than one customer/legal manufacturer wants to sell in Japan, each manufacturer would need to apply for their own accreditation. The accreditation is granted for each manufacturing establishment according to the category specified by the Enforcement Regulations. Therefore, each manufacturer would have their own accreditation number.
In the case of a subcontract manufacturer, it would be the responsibility of the legal manufacturer to obtain and maintain the foreign manufacturer's establishment registration. The subcontract manufacturer would need to comply with the quality and manufacturing standards set by the legal manufacturer and the regulatory authorities.
For reference, see:
PMDA (Japan): Explanation of Application for Accreditation of Foreign Manufacturers