マレーシア医療機器販売に関するMDAからの通達(2017.12.22)
医療機器法（Medical Device Act 2012 (Act 737) ）の完全施行は2018.6.30に延期
MDA(Medical Device Authority)は医療機器に関する登録制度の完全施行を2018年6月30日まで6ヶ月延期することを発表した。
MDAによると、今回の措置は、業界からの強い要望に答えるものだが、今回の延期がペンディングになっている医療機器品目の登録をより完了させることで、病院や医療機関の医療機器購入に関する混乱を低くする狙いもあるという。
- Point
- MDA（マレーシア医療機器庁）の承認を受けるためにはCAB（Conformity Assesment Boies）による事前審査をクリアする必要があるため、実際には企業側の準備の目安としては2018年3月までに終わらせるスケジュールで取り組む必要があるでしょう。
医療機器法の導入に関する期限延期は過去にも何回かありましたが、さらなる延長の案内がでる見込みは今回に比べるとかなり低くなると見ています。
企業側は実質最後のチャンスとなる可能性が高くなっておりますので、早めに確実に対応することをお勧めします。
以下Google翻訳による英訳になります。
Press Statement of Medical Device Authority 22 December 2017 – Extension Period Moratorium For Medical Device Registration under Section 5 of the Medical Devices Act 2012 (Act 737)
Posted by DG OF HEALTH on Dec 22, 2017
Referring to the announcement issued by the Medical Devices Authority (PBPP) on the full enforcement of the medical device registration requirements under section 5, Act 737 issued on 25 July 2017, it is informed that PBPP at its meeting on 18 December 2017 has agreed to provide a connection for period of moratorium on registration of medical devices. After considering high demand from the industrial medical device side The moratorium on the moratorium is until June 30, 2018 and no longer after the suspension of the moratorium. It only applies to establishments that have submitted an application on or before June 30, 2016. With this extension, a letter of acknowledgment of application for the registration of a medical device under the Medical Device Act 2012 (Act 737) may still be used as a document support for the acquisition of medical devices.
For medical devices made for registration after June 30, 2016 will only be allowed to be imported, exported or placed in the market after they are registered.
The postponement of the moratorium will provide an opportunity for establishing completion of documentation to the pending registration of medical devices. It also reduces the disruption of procurement of medical devices in hospitals and institutional health facilities PBPP intends to advise an establishment which has applied to register their medical equipment under this Act but has yet to submit complete information to take appropriate action to resolve their application to avoid any problems when this requirement will be fully implemented.
PBPP also wishes to remind that pursuant to subsection 5 (1) of Act 737, medical devices not registered under this Act shall not be imported, exported or marketed while subsection 5 (2) of the Act provides that any person charged with offenses in under subsection 5 (1) of this Act, to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both.
DATUK DR NOOR HISHAM ABDULLAH
Director General of Health Malaysia, as Chairman of the Medical Devices Authority
22-Dec-17
ニュース出展元：MDAホームページ
マレーシアMDA当局のアナウンスはこちら(マレー語)です。(※以下のURLをコピーしてご覧ください。)
https://kpkesihatan.com/2017/12/22/kenyataan-akhbar-pihak-berkuasa-peranti-perubatan-22-disember-2017-pelanjutan-tempoh-moratorium-bagi-pendaftaran-peranti-perubatan-di-bawah-seksyen-5-akta-peranti-perubatan-2012-akta-737/
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