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.

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.

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.

https://ec.europa.eu/docsroom/documents/35241?locale=en

https://ec.europa.eu/docsroom/documents/35242?locale=en

International Council For Harmonisation Milestones

International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step 4 of the ICH process were adopted. They include:

  • Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9 (R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses
  • M9: Biopharmaceutics Classification

To promote innovation alongside continual improvement in the pharmaceutical sector. At the same time strengthening quality assurance and reliable supply of the product.

Adoption of the Q12 guideline “Particularly Noteworthy” was highlighted.

Concept papers and business plans for the 6 new topics mentioned were also finalized.

  • E6 (R3): Good Clinical Practice.
  • E2D (R1): Post Approval Safety Data Management
  • E20: Adaptive Clinical Trial
  • Q5A (R2): Viral Safety Evaluation of biotechnology Products.
  • S12: Nonclinical Bio distribution. Studies for Gene Therapy Products.
  • M12: Drug Interaction Studies.

2 Concept papers outline discussed previously.

  • M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms.
  • Q9: Guideline on Quality Risk Management.

Were also approved during this assembly.

 

International Medical Device Regulators Forum (IMDRF) released 3 final documents on medical devices

World, International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices. This would replace earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).

The documents provides an overview of ,

– General principles of clinical evaluation for medical devices.

– Principles for designing a clinical investigation and ethical considerations.

– Lastly, key concepts and definitions for clinical evidence.

www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf

 

US, FDA exemption of additional class II medical devices

US, FDA proposed the exemption of additional class II medical devices under 5 different product codes from 510(k) requirements. The exemptions followed in accordance to the finalization of a list back in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. FDA has limited the exemptions to certain devices within that specific product code for 4 out of the 5 product codes proposed.

More details are in the link.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23308.pdf

Eudamed upcoming plans

The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.

They have decided to launch the database simultaneously for both medical devices and in-vitro diagnostics come May 2022.

This means that device manufacturers can now postpone their entering of data into Eudamed.

As compared to the current database, the new Eudamed2 will contain different modules

  • Actors
  • Unique Device Identifiers
  • Notified bodies and certificates
  • Vigilance clinical investigation performance studies
  • Market surveillance