Emergo Group helps medical device companies obtain certification or approval to sell their medical devices in Japan. Through our offices in Tokyo, we can guide you through the complex Japanese Pharmaceutical Affairs Law (despite the name, PAL applies to medical devices) and corresponding registration process so you can gain access to this lucrative market, the third largest in the world behind the US and Europe.
For foreign manufacturers, complying with Japan's Pharmaceutical Affairs Law (PAL) of 2005 can be challenging. Few English language documents have been issued by the Ministry of Health, Labour and Welfare (MHLW) and its division, the Pharmaceuticals and Medical Devices Agency (PMDA). Language barriers and a complex registration process make Japan one of the most time consuming markets for medical device manufacturers to enter.
There are two components of the Japanese PAL regulations that are key to doing business in Japan: "Kyoka" and "Shonin."
"Kyoka" is a kind of business license required for Marketing Authorization Holders (MAH), manufacturers, repairers and distributors. If the manufacturing facilities are located outside of Japan, these foreign manufacturing facilities are required to obtain Foreign Manufacturer Accreditation instead of a Manufacturer License.
To market medical devices in Japan, the MAH must register the device through the following procedures. Emergo Japan can assist you with any medical device approval in Japan, regardless of classification.
Pre-market Submission (Todokede) - CLASS I MEDICAL DEVICES
To register and market General Medical Devices (Class I devices), the MAH only need to file Pre-Market Submission to PMDA with no assessment by the PMDA.
Pre-market Certification (Ninsho) - CLASS II MEDICAL DEVICES
Only Class II devices which are specified as Specified Controlled Devices are subject to Pre-market Certification. Class II devices other than Specified Controlled Devices are subject to Pre-market Approval.
To register and market a Specified Controlled Medical Device, the MAH needs to file Pre-Market Certification application with a Registered Certification Body (RCB) and obtain their certification. This procedure is quite similar to European CE Marking using a Notified Body. In fact, several European Notified Bodies are also authorized Japanese RCBs. Each Specified Controlled Medical Device must apply internationally harmonized standards as is the case with CE Marking
Pre-market Approval (Shonin) - CLASS II, III & IV MEDICAL DEVICES
To register and market a “Highly Controlled Medical Device” the MAH needs to file a Pre-market Approval Application with the PMDA and obtain their approval. Class II devices that are not Specified Controlled Devices are also subject to Pre-Market Approval.
Emergo Japan is prepared to assist you with all aspects of the medical device submission, certification or approval process in Japan. We can prepare all necessary documentation and coordinate the submission through our full service office in Tokyo.