Singapore HSA(Health Sciences Authority) applies Review Fee Increase Effective July 1, 2024. With effect from 1 July 2024, a fee increase averaging 5% will be implemented, with a minimum increase of $1 and capped at $200 per fee item. The increased medical device fees are briefly as follows.1.     Medical Device RegistrationProduct registration and evaluation feeClass BClass CClass DClass D with..

HAS Medical device product registration applications,  specifically for in vitro diagnostic devices, should be submitted online through MEDICS, utilizing the CSDT or IMDRF IVD MA ToC.In this regard, the Singapore HSA(Health Sciences Authority) issued a directive document on the submission of product registration on March 1, 2024.It details the process for uploading documents related to either th..

The Medical Device Control Division of the Thailand Food and Drug Administration (Thai FDA) has recognized the Singapore Health Sciences Authority (HSA) as a reference regulatory agency. The Thai FDA and Singapore HSA have agreed to collaborate to expedite the registration process of medical devices through a Regulatory Reliance Program. Participation is possible if you are a medical device regi..

CPSO issued a circular No. CPSO-310323-08 to provide an update on the registration requirement of 13A fused connection units (switched), which are classified as Controlled Goods (CGs) under the Consumer Protection (Safety Requirements) Regulations (CPSR). Currently, the products need to comply to SS 403.1997 (or newer editions) for registration under the CPSR. As the current standard had recentl..

The CPSO issued a circular No. CPSO-100223-07 on February 10, 2023 to provide clarification regarding the types of products which are classified as multiway adaptors under Consumer Protection (Safety Requirements) Regulations (CPSR). The definition of Multi-way Adaptor on CPSR is adaptors which are intended for household use, have more than one set of socket contacts, and which may or may not be..

Im letzten August veröffentlichte IMDA eine neue technische Vorschrift für SRD. Die diesmal veröffentlichten technischen Vorschriften ersetzen Vorschriften von 2018 und enthalten viele Änderungen. Die wichtigsten Änderungen sind nämlich : ​1. Die Befolgung von IEC 62368-1 ist durch Hinzufügung von Sicherheitsaspekten in den Anforderungen geregelt. 2. Die EMS-Testspezifikation CISPR 24 wird zu CI..

Singapur_PSB(EMC/Safety) Zeitraum : 6-7 weeks Benötigte Dokumente : - Application - Manual - CB and CB test report - Label - In/External photo - Local representative information Probe : N/A Gültigkeitsdauer : 3 years Nennspannung in Singapur Für weitere Fragen über die Zertifizierung in Singapur stehen wir Ihnen jederzeit gerne per E-Mail zur Verfügung info@jnmglobal.net

Singapur_IMDA(wireless/radio) Zeitraum : 4-5 weeks Benötigte Dokumente : - Application - Manual - Local representative information - CE test report Probe : N/A Gültigkeitsdauer : 5 years Nennspannung in Singapur Für weitere Fragen über die Zertifizierung in Singapur stehen wir Ihnen jederzeit gerne per E-Mail zur Verfügung info@jnmglobal.net

1. IMDA (Kabel- und kabellose Zertifizierung) - Zeitplan : 3-4 Wochen - License holder: Lokale Vertreter/Importeure - Benötige Dokumente 1) Antrag 2) Handbuch 3) CE & CE Test report - Probe : N/A - Gültigkeitsdauer : 5 Jahre 2. Safety CoC (Sicherheit) - Zeitplan : 4-6 Wochen - License holder: Lokale Vertreter/Importeure - Benötige Dokumente 1) Antrag 2) Handbuch 3) CB & CB Test report 4) Innere/..

*ACD規定によって下記内容表記が必須（英文併記必須） -製品名 -使用方法及び製品効果 -製品前成分表示 -製造者及び製造国 -輸入または製造社の名前と住所 -配合（重量/容量） -製造日及び有効期間 -注意事項 -製品タイプ -製品申告番号 追加お問い合わせがあればいつでもご連絡くださいませ。 info@jnmglobal.net info@jnmjapan.net maketing@jnmglobal.net