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JAPANESE MARKET OF MEDICAL DEVICES

PRESENTED BY-Anup kumarDept. of Medical Devices(NIPERA1618MD01)

SUBMITTED TO-Dr. Mukty Sinha

CURRENT MARKET TRENDSAccording to MHLW, the japanese market for medical devices reaching in 2016 was approximately $37.6 billion & expected to reach $45 billion by 2020.

Becomes large (ranked 2nd in growth rate) and well established.

Remains heavily dependent on importers,especially for sophisticated devices

The official figures for U.S exports to japan were limited to 23% market share.

Espicom Business Intelligence reported that Japans’smedical device market will exhibit a CAGR of 3.8% from 2013 to 2018.

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USA43%

EU26%

JAPAN14%

OTHERS17%

GLOBAL STATISTICS ON MEDICAL DEVICES PRODUCTION(2016)

10/27/2016 4STATISTICAL CHANGES

WHY JAPAN…?

High expectations due Japan’s aging population of 127 million& continued demands on improved treatment as well as better quality of life for advanced sophisticated medical devices &regenerative medicines.

3rd largest global economic country.

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PMDA…It is a Japanse regulatory agency that working together with MHLW to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.

FUNCTIONS-

GLP/GCP/GMP/QMS inspection

Scientific review of marketing authorization application of medical devices

Monitoring of post-marketing safety

Monitoring of clinical trials & it’s data analysis.

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MHLW…The Ministry of Health, Labor and Welfare(MHLW) is one of the regulatory authority of the pharmaceutical as well as Medical devices in Japan.

PFSB handles the following function of MHLW….

Issue of a manufacturing license

Monitoring of clinical studies & it’s data

Give a marketing approval & reviews that approval if required

Issue a license for marketing authorization holder.

Post-marketing safety measures

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CLASS I DEVICES…General controlled medical devices with extremely low risk.

Regulatory requirements-

I. Self-declaration without no certifiticate by PMDA(Todokede)

II. Pre-market submission of marketing notification to PMDA

Examples- x ray film,scalples, knife, sphygmomanometer etc.

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CLASS II DEVICES…Specified controlled and controlled medical devices with moderately low risk to human body.

REGULATORY REQUIREMENTS-

I. Pre-market certification (Ninsho)to be granted by a registered third-party certification body like Fuji pharma co. ltd, cosmos corporation, Japan chemical quality assurance org. etc.

Examples- MRI, Digestive catheters etc.

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CLASS III DEVICES…Highly controlled medical

devices with medium risk to human body.

REGULATORY REQUIREMENTS-

I. Pre-market approval (shonin) from MHLW Minister to be granted based on the scientific review at PMDA.

Examples- Artificial bones, dialyzer etc.

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CLASS IV DEVICES…Specially highly controlled medical devices with high risk to human body.

REGULATORY REQUIREMENTS-

I. Pre-market approval (shonin) from MHLW Minister.

Equivalent to class III of EU MDD.

Examples-Cardiac stents, artificial heart valves,pacemakers etc.

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BUSINESS MODELS…It varies depending on the-

I. Uniqueness and Technological levels of device

II. Financial means and possibility to invest in the Japanese market

Types of model-

A. Establishing own company in Japan

B. Joint development with local partner

C. Licensing out

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REGULATORY PROCESS…It involves a seven steps approach to Japanese market

access.

STEP I- Determination of regulatory pathway by finding out device classification according to the PAL & the availability of a JMDN code.

STEP II- Appointing a local organization like MAH or D-MAH for registration of the product ,manufacturing facilities and creating bonding with PMDA.

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MAH & D-MAH REQUIREMENTSShould be based in Japan

Having the formally licenced by MHLW

Must be employ at least three staff members-

General manager

Quality manager

Safety manager

Must implement GQP and GVP system

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REGULATORY PROCESS(CONT’D)STEP III- Submit application to the PMDA for a “Foreign Manufacturer Accreditation”

Needed when manufacturing facilities are located outside Japan.

Attached the new registration form(Form No. 18) to obtain a product manufacturing code.

Supporting documents such as medical certificates, product lists, summarization of features etc.should be included.

MAH submit the form to PMDA.

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REGULATORY PROCESS(CONT’D)STEP IV- Implementation of a quality system compliant with the PAL & MHLW

Preparation and submission of QMS conformity assessment application.

QMS is similar to ISO 13485 and US Quality system regulation(21 CFR part 820)

Although QMS is largely based on ISO 13485:2003; in few cases MHLW ordinance 169 also being implemented.

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REGULATORY PROCESS(CONT’D)STEP V- Preparation and submission of medical device certification/approval to PMDA or RCB depend on how device is classified in the Japanese system.

CLASS I- Todokede & premarket submission of marketing notification to PMDA.

CLASS II- Ninsho to RCB or 3rd parties

CLASS III & CLASS IV – Shonin to MHLW Minister.

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REGULATORY PROCESS(CONT’D)STEP VI- Quality management system audit

PMDA- It conducts on site audits for new medical devices, class II controlled, class III & CLASS IV devices and those devices requiring clinical investigations.

RCB- It conducts the audit for class II specified controlled devices.

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REGULATORY PROCESS(CONT’D)STEP VII – Final certification process by PMDA or RCB

Submission of an insurance coverage request

Class I – No certification from PMDA/RCB

Class II – Pre-market certification issued by RCB with in 3-6 months.

Class III & Class IV – Pre-market approval certificate issued by MHLW with in 8-16 months. This certificate does not expire.

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COMPARISON…

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JAPANESE USA EU

1.Total market value-$37 billion2.It imports around 35%3.Regulatory agencies are PMDA,MHLW & RCB.

4.Classification done mainly based on risk.

5.Submitted documents for certification are Todokede,Ninsho&shonin.

1. Total market value-$150 billion

2. It imports 2-5%.3. US-FDA,CDRH

control the regulatory process.

4. Devices are classified based on risk.

5. It including Pre-market notification i.e 510(k) &PMA.

1. Total market value-$58 billion

2. It imports 10-15%3. Notified Bodies &

Harmonization Standardization act as regulatory agencies.

4. Classification based on degree of invasiveness, body contact time,local&systemiceffect .

5. According to CE modules different technical documents submitted for CE marking

COMPARISON(CONT’D)…JAPANESE USA EU

6.Standards are QMS for medical devices #1128 & GMP #40/63 ordinance.7.Conformity assesmentdone by Government body.8.Product recall and approval result publically not disclosed.

9.Data of clinical trials needed in details for certification.

6. It follows QS(21 CFR Part 820)

7.It is also done by Government.

8. All the information related to regulatory publically disclosed in respective US-FDA website.9. It also involved clinical trials in details.

6.It follows EN46001 /ISO 13485 & EN46002/ISO 134887.A third party involved.

8. Such type of information not publically disclosed

9. Clinical trials are done but not in details.

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CONCLUSION…With manufacturing of innovative & unique medical devices and having a total market volume of 37 billion Euro ,Japan now becomes world’s second largest medical devices behind the US.

Still,it imports about 35% of devices and have access to only half of the advanced medical devices that are available in the US & EU due to the complicated regulatory process.

However, in an effort to ease market access, Japanese MHLW has been implementing an action programmefocusing on highly needed medical devices for faster approval review.

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