The revised Regulation for Supervision and Administration of Medical devices (article 53) that went into effect on June 1 enhances the abilities of some medical facilities to develop and use unregistered IVDs as Laboratory Developed Tests (LDTs) in China. This revision only... Read More
The Filipino FDA has proposed a shorter review time for drugs if their clinical studies are completed successfully and approved by the US FDA, PMDA, TGA, EMA, and UK/Canadian FDAs. These approvals would only apply for drugs that can help with health... Read More
On May 18, the Ministry of Health and Family Welfare announced a new Rule 43A, which outlines the conditions in which an approved device license can be canceled or suspended. Per this new rule, if a device license does not comply with... Read More
As drug registration applications grow dramatically in China, so will the CDE audits of drug manufacturing facilities according to the Center for Drug Evaluation (CDE). Earlier this year, the CDE set up a 3-tier system for audits of drug factories including low,... Read More
China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... Read More
On May 9, the MHLW issued a notice that they will accept online applications for drugs, medical devices, and regenerative medicine products. Other types of products that can be submitted online include applications for API master files, GCP/GPSP onsite inspections, and partial... Read More
On April 1, Malaysia’s Medical Device Authorities (MDA) issued a guidance document further classifying devices into 3 categories – 1. Non-invasive medical devices, 2. Invasive medical devices, and 3. Active medical devices. In addition to these categories, a number of new rules... Read More
As software as a medical device (SaMD) gains significant traction in Singapore, the HSA has recently issued Guidelines on the Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software. This guideline, which references the International Medical Device Regulatory Forum’s (IMDRF)... Read More
Historically, Japanese drug registration lagged approval in the West by a number of years. However, in the last 7 years or so, regulatory changes in Japan have expedited approval there. These changes include more drug reviewers, a simplified approval process, an updated... Read More
Japan is planning to establish a new system (Kin-kyu-sho-nin) in case of emergencies that will allow new drugs and devices to be urgently approved without going through an efficacy confirmation process. Under this new approval system, manufacturers of new drugs only need to provide existing... Read More