• 2025-05-29 10:06:54

On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices, which will come into effect on October 1, 2025.

• 2025-03-25 03:01:27

Effective March 1, 2025, all medical device advertisement applications must be submitted exclusively through the online Google Form platform. This transition is designed to enhance operational efficiency, simplify the submission process, and provide a smoother, more user-friendly experience for all applicants.

• 2022-03-25 10:41:47

Indonesia's MoH has announced the integration of their licensing system: REGALKES with OSS RBA (Online Single Submission Risk-Based Approach) for new applications of marketing permit and their plans on integrating more licensing services with OSS RBA.

• 2022-02-18 08:27:38

The Medical Devices Authority (MDA) announced the notification prohibiting the sale of optical devices and contact lenses on any e-marketing platform except registered optometrists, opticians, and businesses registered with SSM, following standards published on the Malaysian Optical Council (MOC) official website.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-03-29 01:45:09

Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.

• 2021-01-08 02:18:25

We have European MDR Online Training with Croma – Director of Regulatory Affairs Mr. Arkan Zwick and Head of RA-GCD, deputy QPPV at Croma Ms. Alexandra Baer

• 2020-10-27 06:10:24

The Qualtech team is happy to announce that Europe-Taiwan Biotech Association and Society for Promotion of East West Knowledge Transfer invited our specialists to share their medical device and pharmaceutical products registration experience at the International Online Conference on November 10, 2020.

• 2020-09-15 09:06:00

PFDA created a new portal for the Radiation Regulation Division (RRD) which will be utilized for the online transactions for radiation facilities.

• 2020-06-11 09:36:28

A new online submission system has been implemented for one year, and NMPA notifies that the agents should renew the CA as soon as possible to ensure the certificate validity.