Newsletter

Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

  • 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

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China: NMPA Releases New IVD Reagent Classification Catalog – February/March 2025

China: NMPA Releases New IVD Reagent Classification Catalog – February/March 2025

  • 2025-02-21 04:28:54

The NMPA's new IVD Reagent Classification Catalog, effective January 1, 2025, introduces a standardized classification code format for streamlined registration. The update replaces the previous system, requiring compliance with the "6840-XX-XXXXX" format and providing guidelines for multiplex and unclassified products. Early preparation is essential to avoid approval delays.

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INDONESIA: RECLASSIFICATION OF FILTER PAPER AS A MEDICAL DEVICE – February/March 2025

INDONESIA: RECLASSIFICATION OF FILTER PAPER AS A MEDICAL DEVICE – February/March 2025

  • 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

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Philippines: Understanding FDA Administrative Order No. 2024-0016: Updated Fees and Guidelines for Medical Device Applications – February/March 2025

Philippines: Understanding FDA Administrative Order No. 2024-0016: Updated Fees and Guidelines for Medical Device Applications – February/March 2025

  • 2025-01-22 06:13:50

Administrative Order No. 2024-0016 sets a new schedule of fees and charges by the Food and Drug Administration (FDA) of the Philippines for all regulated products, including medical devices, drugs, food, and cosmetics. The updated fees aim to simplify compliance for manufacturers and distributors while keeping pace with the growing demands of the healthcare industry. This change ensures more efficient processes for licensing, product registration, and market access.

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Thai FDA - Updated Advertising License Regulations for Medical Devices

Thai FDA - Updated Advertising License Regulations for Medical Devices

  • 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

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Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

  • 2025-02-20 11:06:06

The Thai FDA has launched a priority track for 6 types of medical devices targeting Non-Communicable Diseases (NCDs), enabling faster approval for essential healthcare solutions. This initiative is designed to ensure quicker access to vital healthcare solutions, providing medical device companies with faster market entry for devices targeting public health challenges.

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VIETNAM: MINISTRY OF HEALTH EXTENDED THE VALIDITY OF IMPORT LICENSE BY AMENDING AND SUPPLEMENTING DECREE NO. 98/2021/ND-CP, AS REVISED BY DECREE NO. 07/2023/ND-CP – February/March 2025

VIETNAM: MINISTRY OF HEALTH EXTENDED THE VALIDITY OF IMPORT LICENSE BY AMENDING AND SUPPLEMENTING DECREE NO. 98/2021/ND-CP, AS REVISED BY DECREE NO. 07/2023/ND-CP – February/March 2025

  • 2025-02-20 10:09:30

Decree No. 04/2025/NĐ-CP, released on January 1st, 2025, by Vietnam MOH, extending the validity of import license until June 30, 2025, on the Decree amending and supplementing of Clause 2, Clause 3, and Clause 4, Article 76 of Decree No. 98/2021/ND-CP, as revised by Decree No. 07/2023/ND-CP, regarding medical device management.

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