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Global Regulations for Medical Device Grouping

Grouping policies differ by region, but most regulatory authorities provide guidelines to determine when devices qualify for bundling. Below is an overview of key markets and their regulations.

Grouping of medical device means also bundling medical device in one registration. The reason could be:

  • Same intended use or indication for use

  • Same material

  • MD acting as a system together

  • Appropriate review by one group at authority

 

Manufacturer should learn how to bundle or group medical devices, because it

  • Saves cost and time for registration

  • Simplifies technical documentation (TD) by one single dossier

  • Makes easier to maintain revision of TD

  • Lets design assessment efficient

 

1. European Union (EU)

 

Regulation: EU MDR 2017/745

  • The EU Medical Device Regulation (MDR) allows for grouping devices under a "device family" or "device group" if they share the same intended purpose and risk classification.

  • For example, catheters of varying lengths but with the same intended use can be grouped.

  • Manufacturers must provide a detailed rationale in the technical documentation justifying the grouping.

 

2. United States (US)

 

Regulation: FDA 21 CFR Part 807

  • The FDA allows bundling of devices under the same premarket notification (510(k)) or Premarket Approval (PMA) if they:

    • Have the same intended use.

    • Are of similar design or components.

  • Variants such as sizes or accessories can often be included in a single submission. The FDA provides specific guidance on device families for bundling.

 

3. China

 

Regulation: NMPA Administrative Measures for Medical Device Registration

  • The National Medical Products Administration (NMPA) permits grouping medical devices as a "product family" if the variations do not alter the device’s safety or efficacy.

  • Examples include disposable syringes of different sizes.

  • Normally one worst case device is only needed for local type testing.

 

4. Brazil

 

Regulation: ANVISA RDC 751/2022

  • ANVISA allows medical devices to be grouped under a single registration if they share the same classification, intended use, and technological characteristics.

  • A common example is orthopedic implants of different sizes.

  • Grouping must be justified in the registration dossier.

 

5. Canada

 

Regulation: Medical Device Regulations (SOR/98-282)

  • Health Canada permits grouping devices under the same product family or system if they share similar technology and intended use.

  • Manufacturers must provide a clear rationale for grouping and demonstrate that the variations do not affect the device’s safety or performance.

 

6. Japan

 

Regulation: PMDA Guidelines for Medical Device Registration

  • The Pharmaceuticals and Medical Devices Agency (PMDA) allows devices with the same intended use and design to be grouped.

  • Bundling is commonly used for surgical instruments or diagnostic devices with minor variations.

 

7. Australia

 

Regulation: Therapeutic Goods (Medical Devices) Regulations 2002

  • The Therapeutic Goods Administration (TGA) allows grouping under a "single ARTG entry" for devices with common intended purposes, such as a set of surgical instruments.

  • Manufacturers must demonstrate that the variations are minor and do not affect overall safety and efficacy.

 

Challenges and Best Practices

 

While grouping offers several benefits, challenges may arise in markets where the criteria for grouping are stricter. For example:

  • Interpretation of Grouping Rules: Some jurisdictions require a detailed justification for every grouped device, which can add complexity.

  • Explanation of difference bw. multiple devices in single registration

  • Compliance Across Regions: Devices grouped under one regulatory system may not qualify for grouping in another.

 

To overcome these challenges:

  1. Perform a Gap Analysis: Evaluate regulatory requirements in each target market before bundling devices.

  2. Provide Clear Documentation: Include a robust justification for grouping, supported by technical data.

  3. Engage Local Experts: Regulatory consultants can help interpret local grouping policies and avoid delays.

 

Conclusion

 

Grouping of medical devices is an efficient approach to regulatory submissions, reducing costs and administrative burdens while maintaining compliance. Manufacturers should leverage grouping policies to optimize their global market strategy, ensuring alignment with each jurisdiction’s specific requirements. By understanding the nuances of grouping regulations and preparing thorough documentation, manufacturers can accelerate market entry and maintain compliance across diverse regions.

For tailored guidance on grouping your medical devices in global markets, contact us today.

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