JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
There are three types of marketing business licences for medical devices: • a Type 1 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class III or IV; • a Type 2 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class II; and • a Type 3 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class I. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The Pharmaceuticals Law governs the import and export of pharmaceuticals and medical devices. Imports of pharmaceuticals and medi- cal devices from outside Japan are, in princi- ple, subject to the same marketing regulations applicable to products manufactured in Japan. Importers of these products are subject to requirements regarding marketing authorisation, marketing business licences and accreditation as a foreign manufacturer. A manufacturing business licence is required for the manufacture of pharmaceuticals or medical devices that are to be exported from Japan. Although marketing authorisation is not neces- sary, a separate registration for manufacturing pharmaceuticals or medical devices for export is required.
The relevant prefectural government regu- lates marketing business licences, whereas the MHLW regulates accreditations for foreign manufacturers. 7.2 Importer of Record of Pharmaceuticals and Medical Devices In principle, an importer of pharmaceuticals or medical devices must obtain a marketing busi- ness licence, and is required to present cer- tificates of the marketing business licence and the marketing authorisation for each particular imported product to the relevant customs house. The Pharmaceuticals Law provides for excep- tions to these requirements, such as where an individual imports small amounts of these prod- ucts for their personal use. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, import of pharmaceuticals or medi- cal devices is not permitted unless the import- er on record possesses a marketing business licence and a marketing authorisation for each particular imported product. The Pharmaceu- ticals Law provides for exceptions to these requirements, such as where small amounts of these products are imported by an individual for their personal use. As regards permitted excep- tions in the case of emergency situations, see 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations . 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In addition to obtaining a marketing business licence and marketing authorisation when importing pharmaceuticals or medical devices, it may be necessary to change the product’s packaging to conform to product description and information requirements provided under the Pharmaceuticals Law. By way of an exam-
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