• 2026-07-28 02:39:21

Starting July 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. This article provides a detailed 2025 versus 2026 fee comparison, highlighting an upward adjustment of approximately 4.7% to 6.3% across various submission and maintenance categories. It also includes strategic insights from Qualtech on leveraging overseas approvals and managing hidden compliance costs to optimize long-term operational budgets and market access strategies

• 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.

• 2023-02-23 02:02:05

According to the MDR and the IVDR, notified bodies shall make their standard fees public. In this guidance, the MDCG clarifies the requirements of the list of standard fees and provides the corresponding templates.

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2021-11-24 08:44:32

With the implementation of Risk Classification under the new regulation, Thai FDA agreed to make an amendment to the evaluation expenses. The evaluation fee shall follow the new rates unless the applicant is eligible for a waiver or exemption.

• 2021-04-20 03:47:45

The major impacts to TFDA's medical device regulations and fees are brought to you by Qualtech.

• 2021-02-22 02:52:52

The Ministry of Finance has issued Circular No. 112/2020/TT-BTC, which regulates rates of a number of charges and fees to support and remove difficulties for production and business. It also ensures social security, in response to the Covid-19 epidemic, effective from January 1 to June 30,2021.

• 2020-09-15 09:26:39

In Vietnam, the fees for processing applications for license to sell and import medical devices will be reduced 30% from July 8th 2020 to December 31th 2020.

• 2020-02-21 07:07:52

The PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification.

• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,