Medical Device Registration in Japan

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Japan’s regulatory process for medical devices

Medical Device Registration in Japan In this presentation… • Why Japan? • Characteristics of the Japanese market • Overview of the regulatory process • Device classification scheme • Foreign Manufacturer Accreditation • MHLW Ordinance #169 • In-country representative (D-MAH) • Registration certificate validity • Length of the process • How much it costs



Why export to the Japanese market?

• Population of 127 million, 3rd largest global economy

• Japan’s medical device market totals $27 billion

• Expected to reach $39 billion by 2015

• Japan’s population is aging at a faster rate than any other developed nation, spurring more demand for healthcare

• Solid domestic device market, but also huge importer

Sources: Japan External Trade Organization, Japan Ministry of Health, Labor and Welfare



Japan’s population is shrinking, but…



Demand for medical devices will grow because the median age is rising quickly, and older people utilize healthcare much more intensively.



Why Japan? Opportunity for exporters…

USD $1 Euro €1 GBP £1

Cost to Japanese buyer in

July 2008 ¥106 ¥167 ¥210

Cost to Japanese buyer in

October 2011 ¥77 ¥106 ¥121

Change -27% -37% -42%

American, Canadian and European exporters are far more competitive with Japanese domestic producers than they were even 3 years ago.



Japanese market characteristics

• Large, mature economy and medical device market • Large target universe • Daimyo System • Complex, expensive distribution system • Relationship based sales • Socialized healthcare system • Heavy regulatory requirements



The Japanese regulatory process

START

Now we will explain the process…



Step 1: Determine Regulatory Pathway

Your regulatory pathway is determined by your device classification according to the Japan Pharmaceutical Affairs Law (PAL) and the availability of a Japanese Medical Device

Nomenclature (JMDN) code

Class I Class II Class II Class III Class IV

Increasing risk to patient or user

General Specified Controlled

Controlled Highly Controlled

Highly Controlled



Determining JMDN Codes

• Japan Medical Device Nomenclature (JMDN)

• Broadly based on Global Medical Device Nomenclature (GMDN)

• Proper code selection is critical!

• Need experienced professional fluent in Japanese to make correct selection as numbering system can differ

コード



JMDN Codes Information



JMDN Codes Information (translated) JMDN: Passer, suture, single-use (Code: 37839002) CLASSIFICATION: Class II DEFINITION: A surgical instrument for passing sutures and suture needles through tissue. Typical passers may be flexible or rigid rods with handles that have hooks, catches or clasps to hold the material being passed through the tissue. Passers may also be ring handled instruments with extended, straight or slightly curved blades. The device is single use. CERTIFICATION STANDARD: No. 425: Certification Standard for Single use products to which JIS T0993-1 is applied. APPLICABLE JIS: JIS T0993-1 INTENDED USE: To be used for puncturing a hole through tissues to pass sutures or suture needles



Application Review Categories

New No existing applicable JMDN code

Improved Existing JMDN Code with submission based on new technical file

Me-too Existing JMDN code with submission based on a registered technical file



Application Modules

Class IV: New device

Class IV: Improved device (with clinical investigation)

Class II or III: New device

Class II or III: Improved device (with clinical investigation)

Class IV: Generic device (with approval standard, without CI)

Class II or III: Generic device (with approval standard , without clinical investigation)

Class IV: Improved device (without approval standard or clinical investigation)

Class IV: Generic device (without approval standard or clinical investigation)

Class II or III: Improved device and Generic device (without approval standard or clinical investigation)



Step 2: Appoint Marketing Authorization Holder

Manufacturers with no local presence in Japan must appoint a Marketing Authorization Holder (MAH) or Designated MAH (D-MAH)* to manage their device registration process and liaise with the Pharmaceutical and Medical Devices Agency

(PMDA), Japan’s medical device market regulator.

* A D-MAH is required to register medical devices on behalf of foreign manufacturers

according to Japan’s Foreign Special Approval System.



MAH and D-MAH Requirements • Must be based in Japan • Must be formally licensed by

the Ministry of Health, Labor and Welfare (MHLW)

• Must employ at least three staff members: general manager, quality manager and safety manager

• Must implement GQP and GVP systems

Far more legal, logistical and regulatory responsibility than European Authorized Representative or US FDA Agent!



Step 3: Submit Foreign Manufacturer Accreditation Application

Submissions to the PMDA must include:

• Application for medical device Foreign Manufacturer Accreditation (Form No. 18)

• Supporting documentation such as medical certificates, product lists and facilities summaries

• Registration form to obtain a manufacturing code

Foreign Manufacturer Accreditation applications are submitted to the PMDA by your MAH.



Step 4: Quality System Compliance

• Manufacturers of Class II, III and IV devices must implement a quality systems compliant with the Pharmaceutical Affairs Law and MHLW Ordinance #169 and submit QMS Conformity Assessment Application

• Similar to ISO 13485 and US Quality System Regulation (21 CFR Part 820)

Class II Specified Controlled

Class II Controlled

Class III Class IV



Ordinance 169 basics…

•ISO 13485 is a certification process, whereas Ordinance 169 compliance is an accreditation for foreign manufacturers and a licensure for domestic manufacturers •Role of MAH – Defines the CUSTOMER as the MAH or other organization that is receiving products •Record and document retention requirements – Ordinance 169 requires specific record retention times for documents and records, whereas ISO 13485 does not prescribe specific time frames

Although based largely on ISO 13485:2003, MHLW Ordinance 169 does differ from ISO 13485 in some regards.



Ordinance 169 basics, continued • Requires that the Engineering Manager is defined as the Management

Representative, whereas under ISO 13485 anyone can fill that role

• Infrastructure Requirements – requirements for facilities, environment, and infrastructure are more detailed in Ordinance 169 than in ISO 13485

• Defines special traceability and monitoring requirements for the classification of Specially Designated Medical Devices

• Requires documented procedures for adverse event reporting, advisory notices, and recalls to inform the MAH, which is not specifically required by ISO 13485



Step 5: Submission to PMDA or RCB

Application submission requirements to the PMDA depend on how your device is classified in the Japanese system.

Prepare Pre-market Approval Application and Supporting documents as attachment including the documents in Summary Technical Document Format and Submit to

PMDA

Submit pre-market Certification

Application to Registered

Certification Body

Submit pre-market Submission to

PMDA




Class I: Pre-market Submissions

• For a Class I low-risk device, file a Pre-market Submission (Todokede) to the PMDA

• The PMDA does not further assess your Class I device



Class II Specified Controlled: Pre-Market Certification

• For a Class II Specified Controlled device, have your MAH submit a Pre-market Certification (Ninsho) application to a Registered Certification Body (RCB)

• RCBs are independent firms authorized by the MHLW to certify Specified Controlled devices



List of Licensed Japanese RCBs

BSI Japan K.K. SGS Japan

Cosmos Corporation TÜV Rheinland Japan Ltd.

Fuji Pharma Co. Ltd. TÜV SÜD Japan Ltd.

Japan Association for the Advancement of Medical Equipment (JAAME)

UL Japan Inc.

Japan Quality Assurance Organization (JQA)

DEKRA Certification Japan K.K.

Japan Electrical Safety & Environment Technology Laboratories (JET)

Japan Chemical Quality Assurance Ltd.

Nanotec Spindler Co. Ltd.



Class II Controlled, Class III and Class IV: Pre-Market Approval

• For a Class II Controlled, Class III or Class IV higher-risk device, have your MAH file a Pre-market Approval application (Shonin) with the PMDA

• Prepare a registration dossier in Summary Technical Document (STED) format for submission along with your Pre-market Approval application



Step 6: Quality System Auditing

Class II, III and IV medical devices are required to undergo quality system audits prior to final certification.

QMS Audit by PMDA* or Prefectural Regulatory Authority QMS Audit by RCB

*The PMDA conducts on-site audits for new medical devices,

Class IV devices and devices requiring clinical investigations.

Class II Specified Controlled

Class II Controlled Class III Class IV



Current as of October 2011

Manufacturer Type Cost

Manufacturer of New devices ¥933,500 (plus travel costs)

Manufacturer of biological devices

¥844,400 (plus travel costs)

Manufacturer of sterilized devices

¥229,800 (plus travel costs)

Manufacturer of other devices ¥155,400 (plus travel costs)

Packaging Manufacturer ¥84,800 (plus travel costs)

Quality System Audit Costs for Foreign Manufacturing Sites



Step 7: Final PMDA or RCB Certification

Self-declaration; No Certification

from PMDA

Pre-market Certification

issued by RCB

Pre-market Approval Certificate Issued by MHLW; Certificate does not expire

0

months

3-6 months

8-16 months


Approvals do not expire but are subject to ongoing QMS requirements.



Final PMDA Review & Certification Costs Application Module MHLW fee Review Conf. Assess.

Class IV: New (with CI) ¥100,000 ¥8,705,500 ¥664,500

Class IV: Improved (with CI) ¥100,000 ¥6,213,000 ¥664,500

Class IV: Improved (without CI or AS) ¥33,000 ¥2,355,400 ¥68,500

Class IV: Generic (without CI or AS) ¥33,000 ¥1,767,700 ¥68,500

Class IV: Generic (without CI, with AS) ¥33,000 ¥429,200 ¥68,500

Class III: New (with CI) ¥100,000 ¥6,7213,300 ¥664,500

Class III: Improved (with CI) ¥100,000 ¥3,721,200 ¥664,500

Class III: Improved (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500

Class III: Generic (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500

Class III: Generic (without CI, with AS) ¥33,000 ¥344,100 ¥68,500

Class II: New (with CI) ¥100,000 ¥6,213,000 ¥664,500

Class II: Improved (with CI) ¥100,000 ¥3,721,200 ¥664,500

Class II: Improved (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500

Class II: Generic (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500

Class II: Generic (without CI, with AS) ¥33,000 ¥344,100 ¥68,500

Current as of October 2011



Regulatory Process Summary Designated Marketing Authorization Holder (D-MAH) (only one contract would cover all product families)

EMERGO GROUP: ¥150,000 or ¥100,000 per month plus 3% or 5% of the invoiced vale of shipments

Time to completion: 4 to 6 weeks to licensing

Foreign Manufacturer Accreditation (only one per facility can be applied to multiple product registration applications)

EMERGO GROUP: ¥170,000 per facility.

MoHLW: will charge fees of ¥148,100 per facility for application processing

Time to completion: 6 to 8 weeks to licensing (typical)

Quality Management System Compliance/Review (Class II, III and IV medical devices)

EMERGO GROUP: ¥420,000 per site (typical)

RCB: fees vary, or

PMDA: between ¥155,400 and ¥933,500

Time to complete: done in parallel with application review by RCB or PMDA

Application and Summary Technical Document Preparation

EMERGO GROUP: fees vary by product between ¥450,000 and ¥3,750,000

Time to completion: 2 to 4 months (typical)

Product Registration Application Review

MHLW: ¥33,300 or ¥100,000

RCB: fees vary, or

PMDA: between ¥112,600 and ¥9,370,000

Time to completion: 3 to 16 months (typical)



Additional Resources

Emergo Group Consulting Services for Japan:

http://www.emergogroup.com/services/japan

Regulatory chart of Japan’s Registration Process:

http://www.emergogroup.com/literature

List of Japanese regulatory documents:

http://www.emergogroup.com/resources/regulations-japan

Thank you for your time!

EmergoGroup.com



http://www.emergogroup.com/literature




http://www.emergogroup.com/

Date post:	22-Nov-2014
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Medical Device Registration in Japan

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