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Vietnam: MOH Updates Medical Device Regulations: Extended Validity Periods Explained – January/February 2025

Vietnam: MOH Updates Medical Device Regulations: Extended Validity Periods Explained – January/February 2025

  • 2025-01-22 03:13:13

On January 1st, 2025, the Vietnam Ministry of Health issued Decree No. 04/2025/NĐ-CP, extending the validity of import licenses for medical devices until June 30, 2025. This decree updates Clause 2, 3, and 4 of Article 76 in Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP. These changes aim to allow businesses to continue operations without interruption and ensure smooth operations in medical device management.

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INDONESIA: REGULATION OF THE MINISTER OF HEALTH NO. 3 YEAR 2024 – ON INDONESIA'S HALAL MEDICAL DEVICE MANUFACTURING - August/September 2024

INDONESIA: REGULATION OF THE MINISTER OF HEALTH NO. 3 YEAR 2024 – ON INDONESIA'S HALAL MEDICAL DEVICE MANUFACTURING - August/September 2024

  • 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

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THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

  • 2024-07-30 02:55:19

Thailand's Ministry of Public Health is enforcing stricter rules for dental devices. Specific dental products like implants and orthodontic instruments can only be sold to certified dentists and approved healthcare providers. Distributors must have selling approval certificates for transparent distribution. These changes aim to enhance patient safety and raise dental care standards, requiring quick adaptation from stakeholders.

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USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

  • 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

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