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With its flush and crumbling population, Japan is the second-largest medical bazaar in the world. Over the accomplished 10 years, Japan has apparent its aged citizenry acceleration sharply, with those over 65 years of age accretion from 10% of its absolute citizenry to added than 20%. With a crumbling all-embracing population, a low birthrate, and a shrinking arrangement of advantageous citizenry to crumbling population, advancement able healthcare has been a antecedence of the Japanese government. From 1997 to 2003, government spending on healthcare added from 6.8% of the GDP to about 8%. Japan charcoal a key bazaar for medical devices, abnormally high-end products, with its medical accessory bazaar still aerial over the blow of Asia’s at $25 billion.


Japan is a huge, adult market, but it additionally has a able authoritative arrangement and abounding altered requirements. To access or aggrandize in the Japanese accessory market, it is acute to break on top of authoritative developments.

The 2005 Biologic Affairs Law (PAL) amendments to Japan’s medical artefact laws independent a cardinal of cogent authoritative changes. These changes accommodate requirements for importing, analytic trials, and postmarket surveillance. Additionally included was a new accomplishing of GMPs for medical devices, which afflicted all accessory manufacturers affairs their articles on the Japanese market. Passing audits beneath these new standards is capital to get one’s accessory registered in Japan. This commodity outlines the audits Japan’s Pharmaceuticals and Medical Accessories Agency (PMDA) now conducts for adopted manufacturers. It reviews the objectives and best practices for administration these audits.


There are two capital types of assay conducted by PMDA. The aboriginal is artlessly to ascribe the barrio and accessories of a architect and to affair a adopted architect accreditation. The added is to appraise the manufacturer’s affection administration arrangement (QMS) to ensure that it meets Japanese QMS standards, as allotment of accepting allotment for a specific device. Alone the added assay is a GMP-based inspection. The aboriginal is alleged an accreditation inspection, and the added is alleged a QMS acquiescence inspection. Although these are alleged audits or inspections, they do not necessarily absorb on-site inspections.

To date, all arise accreditation inspections acquire been conducted through affidavit review, with no on-site inspections. At this point, PMDA is not planning to use on-site inspections in accreditation. The alone accessible approaching barring is if a decidedly chancy accessory comes up that it wishes to appraise added closely, but this bearings is unlikely.

QMS acquiescence inspections, clashing accreditation inspections, may about be on-site. Their anatomy is discussed afterwards in this article.

Accreditation Certification

It is all-important to accept accreditation as a adopted accessory architect afore accepting allotment for a device. The capital claim for this is an assay absorption on a company’s architecture and facilities. It should be acclaimed that for Chic I devices, no assay is appropriate for accreditation. For Chic II devices, a notified anatomy can do the inspection, but alone if the Japanese government has issued abstruse standards for the device. (These standards, issued by PMDA to assimilate assorted accessories such as stents, tend to accord to ISO/ASTM standards.) For aggregate at college accident levels, PMDA itself charge do the inspection. This agency that accessories in Chic II afterwards abstruse standards, Chic III, or Chic IV crave assay by PMDA.

The antecedent appliance should be fabricated to PMDA’s appraisal and licensing assay (ELD). The affection ascendancy assay again performs the absolute assessment. It passes its after-effects to the ELD, which gets the official architect acceptance from the Ministry of Health, Labor, and Welfare (MHLW), and again passes the adopted architect acceptance (nintei) to the applicant.

PMDA requires the acquiescence of a cardinal of abstracts to accept accreditation. Although these may vary, they can be disconnected into a few categories. Aboriginal is advice on the staff: an authoritative chart, the affection administration representative’s chic vitae, and the bulb manager’s self-declaration of health. Added is advice on the product, including capacity of its accomplishment process, as able-bodied as its affidavit to adopted government or free-sale certificate. Aftermost is advice on the accomplishment armpit itself: outline, attic plan, breadth map, etc. Any armpit complex in assembly of the accessory is accountable to inspection. This includes subcontractors, but does not accommodate suppliers of raw materials.

After affidavit submission, PMDA reviews the acquiescence and may conduct a Q&A appearance afore approval or rejection. Accreditation about takes a absolute of about six months and is accurate for bristles years.

As of March 2006, PMDA had accepted the accessories of 126 across accessory manufacturers. Accession 142 inspections were beneath way. As mentioned above, none of these accreditations has appropriate an on-site assay yet. However, procedures acquire been set up in case an assay is alleged for. Besides advantageous for apartment and travel, the architect charge pay a circadian allowance for the inspectors’ time. Allowance and adaptation fees are scaled based on the inspector’s rank and the amount of the burghal visited.

QMS Acquiescence Inspections

The blazon of assay that is added acceptable to acquire an on-site appearance is the QMS acquiescence inspection. This is an accomplishing of the Japanese affection administration system, which was accustomed in its accepted anatomy in April 2005, the aforementioned time that the adapted PAL went into effect. The Japanese QMS is broadly agnate to ISO 13485:2003, or, in added words, medical accessory GMPs. Therefore, this commodity will not go into its capacity in detail but will call the capital agency in which it is altered from its ISO counterpart.

QMS acquiescence inspections are disconnected up by accident akin agnate to accreditation inspections. For Chic I, no assay applies; for Chic II with abstruse standards, assay by a notified body; for all added Chic II as able-bodied as all of Classes III and IV, assay by PMDA. Again, PMDA can accept whether to conduct the appropriate assay on-site or through affidavit only. An assay is a binding allotment of a new medical accessory application, or of a fractional change appliance that involves the accomplishment or affection ascendancy process.

However, if the bulb has already accustomed QMS approval for accession accessory of an according or greater accident class, it will not charge accession inspection. This agency that alike admitting technically QMS assay is allotment of the activity of artefact registration, in practice, the approval is angry to the accomplishment site, not the product.

It is additionally important to accumulate in apperception that the Japanese government requires that manufacturers abide applications through their business allotment holder (MAH) in Japan. (The MAH is the acknowledged article importing accessories into Japan on a manufacturer’s behalf.) This is because the MAH holds albatross for the affection of the accessories it sells, and for appliance purposes, it is advised as a distinct assemblage with the manufacturer. Accreditation of the aboriginal architect is additionally a claim for the abstracted accreditation of the MAH itself.

PMDA about looks for accessories in a high-risk chic (i.e., Classes III and IV) with accomplished acquiescence issues or with accomplishment activity complication back chief the accessories for which to do an on-site assay rather than affidavit review. Best absorption rests on new devices, or cellular or tissue-based devices.

In addition, QMS approvals do not aftermost indefinitely. QMS approval expires afterwards bristles years, and the architect charge administer for face-lifting six months afore expiration. This face-lifting assay can administer to all accessories bogus at the bulb and registered in Japan. PMDA can additionally conduct inspections at its own discretion, in case of letters of affection problems.

QMS inspections are performed on all accessories complex in the affection administration process. This can accommodate alfresco architecture and development accessories or testing labs, whether they are done by the architect itself or subcontracted. However, these alfresco accessories are not included in inspections for authorization renewal.

Documentation Requirements

A key aberration amid Japanese QMS and ISO 13485:2003 requirements is the assembly and aliment of a affidavit alleged the Seihin Hyojunsho, almost agnate to a accessory adept almanac (DMR). The purpose of this affidavit is to detail the accord amid the alone product’s blueprint and the site’s all-embracing affection system. As such, it has a ample cardinal of appropriate items.

Items one through eight in the DMR are items that additionally arise in a accepted anatomy in a artefact allotment document: accessory name, specifications, operation procedures, accomplishment method, architecture and drawings, countries of agent and sale, labeling and packaging, etc. But there are 12 added items besides these. They ambit broadly from testing methods and accumulator altitude to the affidavit of acceding amid the architect and its MAH. In addition, if more-stringent testing methods than those appropriate are used, they too charge be detailed. Every account in the DMR charge affix to a accouterment in the plant’s accepted QMS that is applicative to that specification. In that way, the face-lifting inspectors can appraise the QMS in the ambience of any alone device.

In a preapproval assay (i.e., to get artefact registration), PMDA needs to assay the afterwards abstracts afore it determines whether to additionally accomplish an on-site inspection: a abundant attic plan, the affection administration manual, accessory advice (including the Seihin Hyojunsho), accomplishment activity flow, etc. If the assay is advised to awning assorted devices, accessory advice for anniversary one should be provided.

In a postapproval assay (i.e., for renewal), added abstracts charge be submitted. Further appropriate abstracts include, for the bulb as a whole, a almanac of all artefact recalls in the antecedent bristles years and a acknowledgment of acquiescence with Japanese QMS standards. Abstracts for called articles accommodate the Japanese artefact allotment application, any fractional or accessory change applications, ISO 13485:2003 certification, and QMS surveillance letters for the accomplished two years. The affidavit should additionally accommodate the cardinal of articles bogus per year for the accomplished three years, as able-bodied as explanations for any changes to the affection ascendancy system.

PMDA will, of course, affair a complete account of the abstracts it requires to the architect actuality audited. It has the ascendancy to appeal added abstracts at its discretion.

Inspection Process

In the auditing process, there will be a affidavit assay appearance behindhand of whether there is additionally an on-site phase. This agency that, aboriginal of all, the assorted abstracts declared aloft should be submitted to PMDA or a notified body. PMDA reviews them, and alone afterwards will it adjudge whether it additionally intends to do an on-site inspection. The abstracts submitted should be accustomed or alone separately, afore the audit. PMDA additionally uses those abstracts to advice draw up its own assay plan.

As a rule, PMDA informs a architect of an on-site assay with three to six weeks’ notice, usually afterpiece to six weeks. Circadian fees, travel, and abode agreement apply, as ahead declared for accreditation inspections. The aggregation usually consists of two or three inspectors who assignment as a group. If they appeal any added information, they will appetite to accept it aural one to two weeks of their trip.

The assay activity is adequately aboveboard and commensurable to an FDA inspection. An assay is about appointed to booty about three days. The capital processes advised are those of artefact affection management, administration review, ability control, artefact realization, and measurement, analysis, and improvement.

The accepted arrangement of contest is as follows: aperture remarks; affidavit review; bulb bout (inclusive of questions and comments by auditors); centralized affair amid inspectors; and closing affair amid inspectors and participants. At the closing meeting, auditors altercate any observations or acquiescence issues, which are put into accounting anatomy later. A abounding and complete account of participants should be able in beforehand for anniversary of these events.

If there are acquiescence issues, the inspectors affair a antidotal activity report, followed by a analysis phase. This footfall puts the auditing activity on hold, but does not access fees. Once there are no acquiescence issues remaining, a acquiescence address is beatific anon to the manufacturer, and the abounding assay ­results are beatific to the appellant (i.e., the MAH).

Preparing for an Inspection

The best cogent agency that affects the assay activity is a abutting compassionate of the Japanese QMS regulations. They are accessible from PMDA as MHLW Ministerial Ordinance 169, issued December 17, 2004 (in Japanese only).1 Besides the requirements for the accessory adept file, a architect should additionally accustom itself with the accessory agency in which the Japanese QMS is altered from ISO 13485:2003. Obviously, an analyst is all-important to acquaint finer with the inspectors. However, it is alike bigger to get an analyst who additionally has some adequacy in Japanese QMS. It is additionally accessible to construe some above quality-related documents, such as SOPs, in beforehand for the inspectors’ reference.

Inspectors additionally acknowledge actuality able to go through their items in an alike fashion, so try to set up their bout agenda with a focus on efficiency. They appear with their account of assay items already prepared, which cannot be afflicted during the inspection.

QMS Assay Activity

Over the aboriginal year afterwards the adapted PAL went into aftereffect (April 2005 to March 2006), PMDA accustomed a absolute of 32 applications for Japanese QMS certification. Of those 32, alone four underwent on-site inspections, and two of those four were for adopted manufacturers. The blow of the inspections were done through affidavit assay only. There were no failures or withdrawals, although accession 69 applications were still in activity in March 2006. Currently, PMDA may be absorption added on biologic accomplishment sites, for which 35 out of 53 applicants underwent on-site inspections over the aforementioned 12-month period.


The assay of primary accent for artefact allotment in Japan is the QMS acquiescence inspection, admitting the accreditation assay is added basal and does not absorb on-site inspections. The best action for acquiescence is to accomplish assertive that the baby differences amid Japanese QMS and ISO 13485:2003 are provided for in a company’s affection system. An OEM should additionally facilitate advice with inspectors through abutting compassionate of Japanese QMS rules, basic adaptation of key documents, and a accomplished interpreter. Audits are a analytical aperture activity to affairs articles in Japan, and applications should be able with a abundant accord of care.

Ames Gross is architect and admiral of Pacific Bridge Medical ( Bethesda , MD ). John Minot is an accessory at the firm. To acquaintance the authors, appointment Pacific Bridge Medical’s Web armpit at

1. “MHLW Ministerial Ordinance 169,” (Tokyo: Minister of Health, Labour and Welfare, December 17, 2004), accessible in Japanese only.

Copyright ©2007 Medical Accessory & Diagnostic Industry

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