Hello Anon, Completely agree with Mark that while it does not say this anywhere in the regulations or guidance, a serial approach would prevent any confusion or issues for the reviewer. If submitting read more

Hello Srihari, Typically us understand as the last minute of that day in the local region. Though really in the scheme of things unless the expiration period is really, really short like 2 weeks or even read more

Hi Mallory That's all there is. If using UKCA mark to access the GB market, then the requirements are in the SI (i.e. requirements as per EU Directives, replacing CE mark with UKCA mark, identifying read more

The National Medical Products Administration (NMPA) in China has released a draft Medical Device Administrative Law (MDAL) and is soliciting comments from stakeholders. The MDAL is a novel promulgation read more

Hello Anonymous, Getting the answers you need from someone that knows is critical, and possible. I work with a large group of regulatory consultants, 400+. They range from new consultants to highly experienced read more