EU: Compliance for Portable Batteries and Waste Batteries in Medical Devices and IVDs (w.e.f 18 August 2024)
Under the European Union (EU) Battery Regulation 2023/1542, released last year, all medical device and in-vitro diagnostic device (IVD)...
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ARQon
- Aug 21
- 1 min
Australia: Prescription Lenses and Their Exemption from Medical Device Classification (15 June 2024)
Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...
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ARQon
- Aug 20
- 1 min
Vietnam: DMEC Publishes Decision No.2302/QD-BYT - Guidelines for Evaluation of Legal Documents in Class C and D Medical Device Registration Dossiers
As published by the DMEC of MoH Vietnam on 5 August 2024, Decision No. 2302/QD-BYT will replace Decision No.3007/QD-BYT regarding...
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ARQon
- Jul 24
- 2 min
Hong Kong: Enhanced Measures Announced by DH for Medical Device Procurement Strategy
On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...
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ARQon
- Jul 17
- 3 min
Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....
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ARQon
- Jul 16
- 1 min
China: NMPA Outlines New Standards for Radiofrequency Therapy Devices (w.e.f 1 April 2026)
On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...
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ARQon
- Jul 9
- 1 min
Singapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)
“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...
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ARQon
- Jul 2
- 1 min
Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)
Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...
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ARQon
- Jun 25
- 1 min
India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)
On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...
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ARQon
- Jun 18
- 1 min
Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit Registration
The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...
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ARQon
- Jun 12
- 1 min
France: ANSM Designates AFNOR as the Newest Notified Body
Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...
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ARQon
- Jun 11
- 2 min
Malaysia: MDA Implements One License Per Establishment Role Policy (w.e.f 1 July 2024)
Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...
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ARQon
- Jun 4
- 1 min
India: CDSCO Grants Extension for Import Licenses of Class C and D Medical Devices
The Central Drugs Standard Control Organization (CDSCO) released a circular on 16 May announcing an extension for the importation of the...
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ARQon
- May 29
- 1 min
Indonesia: Implementation of GDPMD Certification (CDAKB) as Marketing Authorization Requirement
The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the...
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ARQon
- May 14
- 1 min
Malaysia: Navigating Trade Barriers for Medical Devices in Nations without Diplomatic Ties
Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...
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ARQon
- May 8
- 1 min
Hong Kong: MDD Introduces a One-Stop e-Service, Medical Device Information System (MDIS)
Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical...
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ARQon
- May 7
- 1 min
Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)
On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...
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ARQon
- May 2
- 1 min
Philippines: South Korean MFDS as Reference Drug Regulatory Authority
On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory...
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ARQon
- Apr 23
- 1 min
Philippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices List
The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26...
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ARQon
- May 3, 2023
- 2 min
Philippines: Regulatory Flexibility Guidelines for Unlisted Registrable Medical Devices
The Food and Drug Administration (FDA) of the Philippines released FDA Circular 2021-002-C on 29 March 2023 for the regulatory...
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