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In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
Beginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
On March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.
Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.
Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.