In February 2018, Malaysia’s Medical Device Authority released the Second Edition of the Guidance Documents on Requirements for Medical Device Labeling. Major changes include: The labels must include the contact details of the manufacturer and authorized representative; The labels must indicate the... Read More
Taiwan’s parliament has passed a bill that establishes new protections for the intellectual property of pharmaceutical companies. The new “patent linkage” system, modeled on the U.S. “Orange Book” approach, is aimed at preventing licenses from being issued for drugs that infringe on... Read More
Until recently, almost all risky medical devices and in vitro diagnostics (IVDs) were required to conduct local clinical studies in China to be receive registration approval there. In 2017, the China Food and Drug Administration (CFDA) issued guidelines for the acceptance of... Read More
In April, Japan will adjust its prices for medical devices and drugs. The device price changes this year will be minor, as there will be no change to the Foreign Average Price (FAP) multiplier. The FAP multiplier is determined by the average... Read More
The Taiwan Food and Drug Administration (TFDA) said in January 2018 that it approved 20 percent more new drug licenses in 2017 compared to the previous year. The major therapeutic areas of the approved drugs were cancer therapies, rare diseases, diabetes, cardiovascular... Read More
Earlier this year, India’s in vitro diagnostics (IVDs) rules of 2017 went into effect. IVDs are now classified in four classes: A, B, C, and D. The 2017 rules have a list of IVDs with their risk classification. More IVDs now require... Read More
On December 28, 2017, the China Food and Drug Administration (CFDA) released draft regulations applying to the overseas development and production of drugs and medical devices for use in China. The CFDA has been expanding its overseas audits since starting its international... Read More
As previously reported in March 2017, Vietnam revised the registration requirements for Class B, C, and D medical devices. At that time, the Vietnamese Ministry of Health (MOH) required these classes to be registered and have a market authorization license by January... Read More
On January 4, 2018, the China Food and Drug Administration (CFDA) released guidelines for the design of medical device clinical trials. The document covers the basics of clinical trials such as blinding and randomization, and goes into the more specific elements of... Read More
The China Food and Drug Administration (CFDA) issued draft rules on December 19, 2017 that would significantly tighten regulation of Medical Representatives (MRs) in the country. Among the proposed requirements, MRs must be registered on a CFDA administered website, must meet specific... Read More