Recently, China came out with Order 739 which has a number of new device regulations. Some of the new regulations include – 1. the use and acceptance of different types of evidence for clinical evaluation, 2. a waiver of country-of-origin approval for... Read More
Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals. By next year, for example, all products used in clinical trials must... Read More
In a boon for international medical device manufacturers marketing their products in Vietnam, the country has lowered the value-added tax (VAT) on a range of imported medical device equipment from 10% to 5%. The new tax rate, which went into force in... Read More
Government health authorities in Singapore have finalized regulatory guidelines on the manufacture, sale, and distribution of medical devices made using 3D-printing technology. The guidelines, first released in draft form earlier this year, are designed to ensure the products, which are increasingly used... Read More
Changes made by manufacturers to software used for medical purposes already on the market in Singapore must be made known to regulators, even if they are considered insignificant, according to new guidance from the country’s Health Sciences Authority (HSA). The direction from... Read More
With regulatory authorities in the Philippines moving to tighten registration requirements for medical devices, manufacturers are voicing concern that government authorities are not building in enough transition time for industry to reasonably comply. Since January, Filipino authorities have begun phasing in new... Read More
Eager to encourage the development within its own borders of pharmaceuticals to meet urgent health needs of its people, Japan’s health authorities have begun discussions on establishing an emergency approval system modeled on that of the United States. While a legal pathway... Read More
The Japanese Ministry of Health, Labor and Welfare issued a notice on September 29, 2021 that stated that Japan has decided to formally start accepting MDSAP reports for medical devices and IVDs as part of the Japanese QMS process for product registration... Read More
Moving to modernize and standardize regulatory review of documentation from pharmaceutical manufacturers, Chinese regulators are launching a pathway to submit pharmaceutical applications, supplements, and reports to authorities using the electronic Common Technical Document (eCTD). The Center for Drug Evaluation of the National... Read More
Five years after Malaysia’s Medical Device Authority (MDA) made it mandatory for foreign manufacturers to register their medical device products to access the country’s market, the authorizations are expiring, but regulators have yet to make it possible for many to be renewed.... Read More