2024年9月6日

OMETA-Qualtech ウェビナー2024

事前質問の解説質問- 1

解説：

インドの規制について：FAQの下記の記載があります。
たとえば、包装のシンボルマークの変更などもMajorChangeに該当しますか？
かなり広い範囲で変更申請が必要に思えます。

38. Whether any change in labeling need to be
notified to Licensing Authority ?
➢ Yes. The Changes in respect of label excludingchange in font size, font type, color, label design
shall be considered as major change as per Sixth
Schedule of MDR-2017.

According to Six Schedule of MDR-2017
If the symbol mark is not related to the change affecting efficacy, intended
use, stability of device, then it will be minor change.
(シンボルマークが、デバイスの有効性、使用目的や性能、安定性に影響を与える変更に該当するかどうかで判断)質問- 2

解説：
The requirements for submission dossier is similar to CErequirements.

インドの規制について：

You may refer to the checklist for the imported device withpredicate device in India.

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/medical-device/14MD.pdf

CEの要求事項とインドの要求事項で異なる項目はありますか？

どちらの方がハードルが高いでしょうか？

However, current EU MDR requirements is more difficult thanIndian requirements.

(申請資料はCEの要求事項に類似。
EU MDRの要求事項の方がハードルが高い。)

質問- 3

解説：
Yes, it is correct.

インドの規制について：
MDR Chap1, Article ３に医療機器の定義が

You may refer to the updated risk class for each category
from CSDCO Public Notice published on official website fromthis link.

ありますが、規制対象となる最新の医療機器リスト

https://cdsco.gov.in/opencms/opencms/en/Medical-DeviceDiagnostics/Medical-Device-Diagnostics/

は、2020年9月に発行された理解でよいで(ご理解の通りです。)

しょうか？
https://cdsco.gov.in/opencms/resources/UploadCDS
COWeb/2018/UploadPublic_NoticesFiles/Final%20Cla
ssification%20of%20MD.pdf

質問- 4

解説：

インドの規制について：

CDSCO will issue a Registration Certificate through online
portal. [MDR, 2017, Article 36 (1)]

クラスA～Dの平均的な審査期間を教えてください。

Registration approval for Class A or B with predicate device, itmight take 5-6 month after submission.
Registration approval for Class C of D with predicate device,
it takes about 9-10 months after submission.
(Class A/B: 5-6ヶ月、Class C/D: 9-10ヶ月)※先行品有りの場合質問- 5
フィリピンの規制について：
フィリピンで医療機器をキット化し、海外へ出荷する場合であり、フィリピン国内で販売しないケースであっても、輸入ライセンス申請は必要となりますか？

解説
The company must have a license or LTO(License toOperate) as medical device exporter andmanufacturer (a. If manufactured in the Philippines
fully, the LTO must have main activity as
manufacturer, b. If only repackaged in thePhilippines, the LTO must have repacking as anactivity in the license.)
CMDN/CMDR must be applied first but must indicatethat it is for export purposes only.
PFDA is generally more lenient/relaxed in theevaluation of products which are intended for export
market. Full technical requirements are expected
and dependent on risk classification.
(CMDN/CMDRが必要です。)

質問- 6

解説：

オーストラリアの規制について：

An Australian TGA sponsor plays a vital role in device registration
process and post market compliance.
Before commercialization of the products, the sponsor will register
the goods with the TGA and also assist to encounter the audits.

TGA 第1章第3項に定義されているスポンサーの役割について確認したい。

定義

The Sponsor maintains the track on Regulatory updates, to help themanufacturing companies meet the updated Regulatory
requirements, by maintaining the technical documents
recommended by the Agency.

• exports therapeutic goods from Australia

The Sponsor shall also maintain the distributor records from themanufacturer.

• imports therapeutic goods into Australia

スポンサーの役割• manufactures therapeutic goods for supply inAustralia or elsewhere-市販前の製品登録、監査対応の支援-規制更新の確認、製造業者が更新された規制要件を満たせるよう、規制当局が求める技術文書の適切な維持管理の支援-ディストリビューターの維持管理(販売記録の管理)• arranges for another party to import, export
or manufacture therapeutic goods.

質問-6-①

解説：
The role of MAH in Japan is similar as Sponsor in TGA.

オーストラリアの規制について：

However, a Sponsor may be different from a Distributor.
Aside from the Sponsor (holder of the ARTG entry), the Manufacturer can also
authorize other Distributors to import the product.

日本での製造販売業者、製造業者、販売業者

A Sponsor is the Australian entity responsible for the supply of the medicaldevice in Australia. The Sponsor's responsibilities include ensuring that themedical device complies with regulatory requirements, maintaining records ofthe device's performance, and cooperating with the TGA in case of post-market
monitoring or audits. The Sponsor must also ensure that the device is includedin the Australian Register of Therapeutic Goods (ARTG) before it can be legally
supplied in Australia.
A Distributor in Australia is responsible for the actual distribution and sale of themedical device within the country. While they must ensure that the products
they distribute are legally included in the ARTG, they are not typically
responsible for regulatory compliance—that responsibility falls to the sponsor.の役割を「スポンサーが一手に引き受けられる」という理解で良いか？

スポンサーの役割は日本の製造販売業者に類似
但し、スポンサーはディストリビューターとは異なる場合がある。
製造業者はスポンサー以外のディストリビューターに製品の輸入を許可することもできる。
スポンサーは、オーストラリアにおいて医療機器の供給に責任をもつ事業体。
スポンサーの責任：①ARTGに機器が登録されていることの確認、②医療機器が規制要件に準拠していることの確認、機器の性能記録の維持、③市販後監視や監査の際に TGA へ協力
ディストリビューターは、オーストラリア国内での医療機器の流通・販売を担当し、流通・販売する製品が ARTG に登録されていることの確認※規制遵守の責任は通常負わない。その責任はスポンサーにある。

質問-6-②

解説：

オーストラリアの規制について：

The role of a sponsor in Australia under the Therapeutic Goods Administration(TGA) is somewhat similar to the role of an authorized representative inEurope under the Medical Device Regulation (MDR), but there are some keydifferences.
(欧州法定代理人の役割に類似)

欧州などの「法定代理人の役割を担う」という理解で良いか ？

Similarities:
Representation: Both roles involve representing the manufacturer in therespective regulatory jurisdictions (Australia for the sponsor, and Europe forthe authorized representative).
Regulatory Compliance: Both the sponsor and the authorized representative
are responsible for ensuring that the medical device complies with localregulatory requirements, including device registration and post-marketsurveillance.
Point of Contact: Both act as the point of contact between the regulatory
authorities (TGA in Australia, and national competent authorities in Europe)and the manufacturer, especially for communication regarding complianceand any necessary corrective actions.
類似点-製造業者の代理としての役割-規制要件準拠の確認責任-規制当局に対する連絡窓口

質問-6-②
オーストラリアの規制について：
欧州などの「法定代理人の役割を担う」という理解で良いか ？

解説：
Differences:
Owner of the license:
The sponsor in Australia is the applicant/owner of Australian Register ofTherapeutic Goods (ARTG) Listing. While European authorized
representative is not the applicant/owner of CE certificate. Manufacturer
including overseas ones will be the owner of CE certificate.
Scope of Responsibility:
The sponsor in Australia has broader responsibilities, including legal
liability for the device on the Australian market. In contrast, while theauthorized representative also shares some liability in Europe, themanufacturer remains primarily responsible.
Market Introduction:
In Australia, the sponsor is also responsible for including the device in theAustralian Register of Therapeutic Goods (ARTG) before it can bemarketed, a role that is typically handled by the manufacturer or authorized
representative in Europe through CE marking under the MDR.
Overall, while both roles are crucial for market access and compliance intheir respective regions, the specific obligations and the extent ofresponsibility can differ based on local regulations.
相違点-ライセンスの保有者: オーストラリアでは申請者/保有者-責任の範囲: オーストラリアでは欧州代理人に比べ、機器の法的な責任を含むより広い責任を持つ-市場への導入: オーストラリアのスポンサーはARTGへの製品の登録責任※上記について、具体的な責務や責任の範囲は異なる場合がある

質問-7

解説：
[India] Raw material changes could be applied the major change
application according to Six Schedule of MDR-2017.

その他：

変更申請ルート有り。Major changeに該当する可能性。
[AUS] Yes, a change application is required if a raw material that willcontact body liquid has changed.

接液原材料が変更されたら、各国にて変更申請
ルートがありますか？
もしくは、再度新規申請をする必要がありますか？

In fact, any changes that may affect product safety, quality,performance, or effectiveness is required to apply for change
application.
However, if the change is so critical or serious that may alter thedevice's risk profile, TGA may be considered it as a new product. In thiscase, a new application is required.
変更申請ルート有り。変更申請要。(変更内容により新規申請の可能性有り)[Philippines] Raw material changes are usually required for change
application.
Whether new application is required or not needs to be judged by each
medical device.
変更申請ルート有り。新規申請の可能性については医療機器毎に判断。