Japan medical device market, the third largest after US and EU, accounts for about 10% of the global medical device market, and it is known that devices of foreign manufacture account for about a half of its annual sales. Japan market is open to safe and effective devices. Therefore it is strongly recommended for companies who consider Japan market to have prior understanding about Japan regulatory system.
The governing law on medical device is “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (PMDL for short hereafter). It defines WHAT, WHO & HOW with relevant specific regulations.
There are about 4,300 medical device stipulated by law, each with specific JMDN (Japan Medical Device Nomenclature) and definition. JMDN is linked with various device attributions, including but not limited to device class according to risk level, intended use and efficacy, specific requirements for maintenance and/or installation.
|Device class||Risk base medical device classification||Classification||Risk Level|
|Class I|| Devices with extremely low risk to the human body in case of problems.
Examples: In vitro diagnostic devices, steel made small devices (including a scalpel, tweezers), X-ray film, devices for dental technique
|Class II|| Devices with relatively low risk to the human body in case of problems.
Examples: MRI devices, electronic endoscope, catheter for digestive organs, ultrasonic devices, dental alloy
|Class III|| Devices with relatively high risk to the human body in case of problems.
Examples: Dialyzer, bone prosthesis, mechanical ventilation
|Class IV|| Devices highly invasive to patients and with life-threatening risk in case of problems.
Example: Pacemaker, artificial cardiac valve, stent graft
There are four main players to handle medical device; manufacturer, marketing authorization holder (MAH), distributor and repairer, each with stipulated qualification.
- Distributors are for local distribution of medical device to Japan end-users.
- Repairers are for field repair.
- Manufacturers are those who design, assemble, and sterilize device and those who dispatch market-authorized devices. Manufacturers outside Japan should be registered as Foreign Medical Device Manufacturer.
- MAH is responsible to keep subject device and its handling strictly compliant to medical device regulations by;
- establishing appropriate quality management environment with device manufacturer(s) that meets the requirements of MHLW Ministerial Ordinance No. 169 (QMS ordinance),
- registering the device and maintain the registration
- authorizing the shipped device to release into Japan market after seeing the compliance
- monitoring device in the market to address to safety / quality problems.
Medical device can only be released into market after device registration. Appropriate QMS network is vital to have the device registered regardless of device class. Program is required to be implemented after market release of PMDL-regulated device to assure its safe use. Some devices needs listing application for NHI reimbursement after device registration based on National Health Insurance Act.
Device manufactured, inspected and labeled is exported to Japan under registration, received by local manufacturer for market authorization by MAH and sent to users via distributors. MAH reports field complaints to manufacturer.
1) Basic QMS network
2) Device registration
a. PtC in Japan registration:
- Does subject device conform to Japan Essential Principle?
- Can the device have applicable JMDN?
- Does the device meet device specific performance/safety requirements?
- Does the device have any predicates in Japan?
- Are all materials required for registration available?
note: Application documents should be made in Japan local language, Japanese. Attached materials shall not necessarily be in Japanese, however, full Japanese translation is required with materials in the language other than English (PMDA, RCB review) and summaries in Japanese may be required with those in English (PMDA review).
b. Medical device registration by device class:
Foreign restrictive certification / approval:
Only qualified Japan MAH can file application and can be the certification / approval holder, however, foreign manufacturer can be an applicant / holder in this exceptional system of application. Designated MAH (D-MAH) handles this registration on behalf of foreign manufacturer.
c. Review (certification / approval):
Application shall be reviewed for;
- Conformity to essential principles and JMDN specific requirements on intended use, functions, safety, effect and efficacy.
- Reliability of the attached materials that evidence above
- Conformity to QMS requirements
Review by PMDA has 3 major categories for 1. new medical device, 2. improved medical device and 3. generic medical device notwithstanding device class. It is strongly recommended to have PMDA pre-submission consultations to determine the appropriate application category.