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.

Indonesia, Exemption from Import Duties for Health Services Goods

The importation of health goods in Indonesia are normally subjected to a fiscal levy through customs duties and taxes in the framework of import (PDRI).

The importation of items are divided into 2, purchase and grant goods. They are normally subjected to fiscal levy through customs duties and taxes in the framework of import (PDRI). Which is likely to cause an increase in prices for imported goods.

To achieve savings and efficiency, the importation of health goods can be provided with fiscal facilities through the exemption of import duties and import taxes (PDRI).

It is very important to be able to distinguish the difference between the subject (recipient of goods), the object (the type of goods) and the allocation of the intended goods. As exemptions of import duties may differ.

This is being done in accordance with Article 25 and 26 of Law No. 17 of 2006 concerning The Amendment of Law No.10 of 1995 on customs.

During the process of issuing goods at the port, do take note of the costs that might arise such as warehouse rental, handling, etc.

Even after the goods are released and cleared, the importer or the receiver has to comply with the provisions set forth in the letter “Decision on Import Duty Exemption” to ensure a proper process.

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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World Health Organisation Latest Guideline on Data Integrity

World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of the reliability of data and information in the production and control of pharmaceuticals.

Due to the recent increase of observations in the integrity of data relating to,

  • Documentation
  • Record Management
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)

The 28-page guideline would assist and recommend companies to use a written data integrity policy. For data documented on paper, WHO warned against the use of pencil, erasers and correction fluid. Companies must ensure that paper records are archived properly by designated personnel in secured and controlled areas.

10 examples of good documentation practices in data integrity are also included in the guideline to offer companies a step by step guide.

Philippines’s FDA has been officially listed ASEAN MRA

Philippines’s FDA has been officially listed under the ASEAN Mutual Recognition Arrangement(MRA) on Good Manufacturing Practices(GMP) for medicinal products. This comes are the 28th ASEAN Consultative Committee On Standards And Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) meeting on 19th & 20th December 2019.

This would result in result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection.

Alongside, increasing confidence in the quality of medicines for consumers, reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines. Philippines would be the 5th country to be listed under the ASEAN MRA on GMP for Medicinal Products.

Launch of International Sterile Medicines Inspection Pilot Program ?

European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.

Specifically, allowing information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and to promote organize joint inspections.

Lasting a minimum of 2 years, which would include;

  • EMA
  • US FDA
  • UK’s MHRA
  • France’s ANSM
  • Australia’s TGA
  • Health Canada
  • Japan’s PMDA
  • World Health Organisation

Throughout the program, participants would coordinate and share their inspection plans alongside other participating authorities. This effort would see inspections being done according to predefined GMP requirements.

Encouraging the coordination of joint inspections rather than sole or concurrent inspections.

This pilot would be applicable to human drugs and certain therapeutic biologics, such as monoclonal antibodies and recombinant proteins excluding vaccines, cell and gene therapies and plasma-derived products.

Malaysia guideline for registration of drug medical device

Fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products in Malaysia.

Medical devices with substances incorporated when used on their own could be considered as a medical product, must adhere to this regulation.

Falling under Class D, Rule 13 of the Medical Device Regulation 2012. A medical device-drug combination product registration require a 3 stage process;

Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)

  • Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
  • Ancillary Drug Dossier (Appendix 2)

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)

Submit the documentation to the CAB, CAB to issue a certificate and report upon satisfactory assessment.

Stage 3 – Application for Registration to MDA

Obtaining the endorsement letter from the NPRA, certificate and report from the CAB, an application be made on Medcast 2.0 for the MDA to evaluate the medical device application.

European Commission release of 8 documents relating to unique device identifiers

Europe, The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs). 4 of them are relating to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose,

*Risk classes

*Design manufacturing characteristics

These UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA respectively. The other 4 documents would deal with UDI human readable interpretation (HRI) formats. Including HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing dates.

More details are in the links.

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