China, Medical Device Regulations. What do you need to know?

National Medical Products Administration (NMPA) is in charge of all pharmaceuticals and medical device regulations in China.

Medical devices are being classified into 3 classes. All according to their potential risks. Class I (Lowest), Class II (Middle) & Class III (Highest).

A further breakdown in the specifics of the 3 classes;

Class I – All devices in which safety and effectiveness can be assured through routine administration.

Class II – All devices involving further controls and monitoring in order to ensure safety and effectiveness.

Class III –All devices used for life support or sustenance, which might be a potential threat to health or relating to any implants into the human body.

If a medical device not manufactured in China wants to be registered in the Chinese market, device samples are required to be sent to NMPA for testing.

All product information on both packaging and labeling must be translated to Simplified Chinese.

The Medical device registration validity is 5 years. If a renewal should be required, the application should be submitted 6 months in advance before the expiry date.

Foreign manufacturers and brands must hire China-based agents to represent their brand in the Chinese market.

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

2019 Round-up & What’s upcoming in 2020

As we close the year of 2019. Let’s look at the most interesting stories of the past year and look forward to what’s installed in the start of the new decade.

United States urged the European Union to push back the MDR deadline by 3 years despite the EU commissioner for health making the statement that the deadline will not be adjusted.

European Commission and Medical Device Coordination Group also released several MDR guidance documents on persons responsible for regulatory compliance and implant cards.

FDA issued a total of 10 PRVs in 2019 which included the latest Merck’s Ebola vaccine. So companies can now sell the vouchers and use them to speed the review of new treatments.

UK pushing back BREXIT to the end of January 2020 saw the UK’s Medicines and Healthcare products Regulatory Agency releasing a series of guidance documents to help pharmaceutical and medical device companies.

Looking ahead to 2020,

We would see;

Several important FDA rule makings and guidance documents.

A better understanding on how BREXIT is impacting drug and device supplies in the UK.

FDA to release 2 revised draft guidance on the post market surveillance of devices and post-approval studies.