Many Western medical companies are coming out with unique software with healthcare applications. Some stand-alone software programs in Japan are classified as program medical devices. Program medical devices generally include a computer program (intangible) or tangible recording media (any magnetic tape, disk, or other... Read More
Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up... Read More
On April 11, the NMPA issued a new Circular on year-end drug annual reporting. China MAH’s must submit 2021 annual reports by August 2022. However, after this year, annual reports must be submitted by the end of April each year. The circular... Read More
The Thai FDA will now evaluate device approval more efficiently if the device has been already approved in Singapore. This also applies to Class B-D IVD’s approved in Singapore. Basically, the Thai FDA will reduce their review time from 150 to 60... Read More
The Indian CDSCO is now discussing the need to test more devices locally to obtain Indian device approval. Recently, a task force has been established to determine what needs to be done to increase India’s testing facilities. Various categories of medical devices... Read More
Most medical devices require registration in Malaysia. Registrations are good for 5 years, and many companies are now facing re-registration. In June, the Malay Medical Device Authority released the new re-registration guidelines. Re-registration applications must be submitted via the MeDC@St application system.... Read More
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