This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import them into Japan must register with the Ministry of Health, Labor, and Welfare (MHLW). Foreign manufacturers of pharmaceuticals, medical devices, etc. must register or renew their registration under Article 13-3 of the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals and Medical Devices. Certification or renewal of accreditation is also required by PMDA.
The processing of certification, registration, renewal, addition or change of classification, change notification, or abolition notification up to the creation date has also been finished. As a result, each time you apply for certification, registration, or manufacturing and marketing approval, please check the status of accreditation and registration directly with the foreign manufacturer that imports medicines, medical devices, etc. into Japan. Following is a list of foreign manufacturers who have received certification or renewal as foreign producers of regenerative medical goods in accordance with Articles 23 and 24 of the same Act.
- (As of June 5, Reiwa 6) List of Certified and Registered Foreign Manufacturers
- (As of June 5, Reiwa 6) List of Certified and Registered Foreign Manufacturers
The registration number and the certification number under the Pharmaceutical Affairs Law will be posted for anyone who is presumed to have been registered as a foreign manufacturer of in vitro diagnostic reagents in accordance with Article 25 of the Supplementary Provisions of the Act on Partial Revision of the Pharmaceutical Affairs Law, etc. (Act No. 84 of 7). Additionally, the certification number before the modification shall be the registration number of a person presumed to have been registered as a foreign producer of medical devices under the same Article.
The list is updated to remove foreign medicines and quasi-drug makers whose validity time has passed. (According to the Pharmaceutical Examination and Living Health Bureau’s notification No. 28 No. 3 dated March 30, 0330, sent to the Director of the Examination Management Division of the Pharmaceuticals and Public Health Bureau of the Ministry of Health, Labor, and Welfare)
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Source: PMDA – Publication
