Japan, Changes to medical device regulations. What you need to know?

An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.

The latest version of the PMD Act covers issues such as

  • Application of Artificial Intelligence
  • Unique Device Identifiers
  • Instructions For Use provided in electronic form

There were also changes made to the requirements relating to pre-marketing application submission and post-marketing surveillance.

The goals of this new change are,

  • Simplification of access to the market to make innovative medical devices accessible to patients.
  • Providing a new vision on the functions of healthcare institutions and professionals.
  • Improvement of the regulatory compliance system.

We would see drastic improvements in compliance and supervision systems.

Thus, making communications with manufacturers more efficient through providing legal clarity and certainty of the regulatory requirements.

UK, BREXIT it’s Official. What’s Next ?

UK, As the clock, strikes midnight on 31st January 2020.

The UK would have officially left the European Union and enter a transition period till 31st December 2020.

During this period, the UK will remain in the EU’s customs union and single market and all rights alongside all obligations of companies and citizens will not be affected.

Further negotiations will be taking place for future trade conditions.

These outcomes remain unclear and can range from a Free Trade Agreement/Mutual Recognition Agreement to the UK dealing with the EU on WTO terms.

But, the UK will not be a member if EU institutional organizations.

MHRA and EU institutions will be updating their guidelines reflecting the outcomes via their website.

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

Upcoming in the later part of 2020, we will see them move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests.

This new initiative would ease the process of making orphan drug designation requests, which are currently being physically mailed to the Office of Orphan Products Development (OOPD) on a CD.

Allowing an even connected information technology system alongside, advanced analytics and improvements in facilitating knowledge management.

Additionally providing external sponsors with an even more efficient submission of documents and enhanced direct communication directly with the FDA.

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