A Review of Regulatory Changes around the Globe

A Review of Regulatory Changes around the Globe

Since 2013, there has been a flood of changes to Medical Device regulations around the world. Many countries are attempting to modernize their regulatory controls over Medical Devices to allow for increased patient safety and greater access to medical devices. Staying abreast of these changes is crucial to any manufacturer who wishes to market their medical device on a global scale.

  • China’s National Health and Planning Commission (NHPC) announced a new policy favoring domestic medical device manufacturers over foreign manufacturers. The reason behind this is that the government is trying to keep the price of devices down to make them more affordable for patients. One side effect of this is that more foreign companies begin exploring option such as joint ventures or acquiring Chinese medical device companies. This policy has yet to be implemented. (1)globe
  • In China, On October 1, 2014 new Medical Device and IVD regulations  went into effect. The changes include, but are not limited to:
    • Extending certificate renewal from every 4 years to every 5 years.
    • Requirement that clinical trials for IVDs must occur after device testing.
    • Possible On-Site inspections for manufacturers in order to raise the bar for quality system management compliance.
    • Elimination of the registration requirement for Class I Medical devices. Manufacturers need only file with CFDA.(2)
  • Mexico’s medical device regulatory body COFEPRIS released a guidance on Technovigilance Reporting. The guidance applies to manufacturers who are commercialized in Mexico. According to Emergo Group, the most important part of the guidance is the announcement that technovigilance reports should cover the past four years or more for products marketed both in Mexico and           These reports must be submitted and approved before registration renewal will be approved. (3)
  • Australia’s Therapeutic Goods Administration (TGA) will be conducting an audit for all ARTG applications supported by CE Marks issued by eight European Notified Bodies. The reason for the audits is that the TGA wants to be sure of the safety and performance of the devices marketed in Australia. The immediate effect will be a delay in market approval for applications supported by these notified bodies. A list of the notified bodies can be found in the TGA Report(4)hands-globe
  • The South African Medicines Control Council (MCC) has proposed regulations addressing Medical Device and IVD registration. The registration requirements are similar to those in other countries. They include:
    • Classification of devices on a 4 tier system (A, B, C, D)
    • Foreign manufacturers must have an in-country authorized representative.
    • Essential Principles requirements.
    • Post-Market surveillance requirements for devices already registered in country.
    • Requirement for an application to be submitted to the MCC Registrar of Medicines for marketing approval.(5)
  • New Zealand and Australian regulatory bodies Medsafe and TGA have been making changes in recent months to harmonize their regulation of medical devices. Medsafe recently changed its definition of medical devices and pharmaceutical products to more closely match Australia’s definition. The changes went into effect July 1, 2014, and include amending the terms “medicine”, “therapeutic process” and “medical device.” Ultrasonic therapy apparatuses and irradiating apparatuses will now be defined as medical devices as well.(6) For the full list of definitions, go to http://www.medsafe.govt.nz/regulatory/categorisation-of-products.asp
  • In Japan, the Medical Device registration process is a daunting one. However, Japan’s Ministry of Health hopes to change that with amendments to Japan’s Pharmaceutical Affairs Law (PAL) and legislation that applies directly to medical devices. The proposed amendments will begin being implemented on November 25, 2014(7). One of the reasons for the reform is to create distinct processes for pharmaceutical and medical device registrations. The hope is that these amendments will make it easier for foreign manufacturers to enter the Japanese market. The changes include:
    • Some Class III devices will become eligible for third-party certification.
    • Simplification of the device registration process
    • Removal of the perfect-level quality system inspection requirements.
    • Proposed timeframes for the review period for medical device applications (12 Months for a new medical device, 9 months for a Modified medical device, 5 months for a generic medical device). (8) (9)saudi-arabia
  • The Kingdom of Saudi Arabia (KSA) is implementing a new requirement that low and medium risk medical devices and IVDs must obtain Medical Device Marketing Authorizations (MDMA). Currently this requirement only applies to high-risk devices and IVDs, however the new requirements will apply to Medium and low-risk medical devices and low-risk IVDs. According to Emergo Group, Medical devices, even ones currently being marketed in Saudi Arabia without MDMA registration, must be registered by the following dates:
    • Medium risk medical devices: December 31, 2014
    • Low-risk IVDs: June 30, 2015
    • Low-risk medical devices: December 31, 2015(10)

Bibliography

  1. Shobert, Benjamin. A New Wrinkle For China’s Medical Device Market. Forbes. [Online] August 21, 2014. http://www.forbes.com/sites/benjaminshobert/2014/08/21/a-new-wrinkle-for-chinas-medical-device-market/.
  2. Eisenhart, Stewart. New Chinese Medical Device, IVD Regulations Take Effect in October 2014. Emergo. [Online] August 04, 2014. http://www.emergogroup.com/blog/2014/08/new-chinese-medical-device-ivd-regulations-take-effect-october-2014.
  3. —. New COFEPRIS Guidance on Technovigilance Report Submissions. Emergo. [Online] Emergo, September 22, 2014. http://www.emergogroup.com/blog/2014/09/new-cofepris-guidance-technovigilance-report-submissions.
  4. TGA. Increased application audit requirements for some medical devices applications. Australian Government Department of Health Therapeutics Good Administration. [Online] September 16, 2014. http://www.tga.gov.au/industry/devices-notice-audit-requirements.htm#.VCsSUct0x2Z.
  5. Eisenhart, Stewart. South African Draft Regulations based on IMDRF Principles Released. Emergo. [Online] September 25, 2014. http://www.emergogroup.com/blog/2014/09/south-african-draft-regulations-based-imdrf-principles-released.
  6. MassDevice. Revised medical device definitions implemented in New Zealand. +MassDevice. [Online] August 05, 2014. http://www.massdevice.com/blogs/massdevice/revised-medical-device-definitions-implemented-new-zealand?page=show.
  7. Eisenhart, Stewart. Japanese Regulators Announce Enforcement Date for New Medical Device and Drug Laws. Emergo. [Online] July 30, 2014. http://www.emergogroup.com/blog/2014/07/japanese-regulators-announce-enforcement-date-new-medical-device-and-drug-laws.
  8. Azeez, René. Time is Money: Changes to the Japanese Medical Device Registration Process. Millennium Research Group. [Online] August 2014. http://www.mrg.net/Blog/August-2014/Time-is-Money–180814.aspx.
  9. Stewart Eisenhart, Emergo Group. Worldwide Medical Device Regulatory Updates – Japanese regulators plan faster medical device registration process. Medical Device Summit. [Online] April 02, 2014. http://www.medicaldevicesummit.com/Main/Features1/Worldwide-Medical-Device-Regulatory-Updates-1864.aspx.
  10. Stewart Eisenhart, Emergo Group. Worldwide Medical Device Regulatory Updates – Medium risk medical devices subject to MDMA registration in Saudi Arabia . Medical Devices Summit. [Online] April 02, 2014. http://www.medicaldevicesummit.com/Main/Features1/Worldwide-Medical-Device-Regulatory-Updates-1864.aspx.
Mack Rubley
mrubley@boston-biomedical.com

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