03 Aug Global Regulatory Update: A Trend towards Harmonization and Enforcement
In the past year, many countries have taken steps to bolster their medical device regulatory systems. Many of the new or modified guidelines and regulations mirror actions taken by other countries around the globe. Some of the themes beginning to become apparent are the use of barcodes in device labeling, the requirement for electronic submissions over hard copies, and new audit initiatives for manufacturers.
Effective June 7, 2015, the Saudi Food and Drug Authority (SFDA) requires that Medical Device Barcodes be used on home-use/lay-person devices. Information regarding the barcode must be included in the Medical Device Marketing Authorization (MDMA) applications to the SFDA. The unique device identifier (UDI) required by the FDA meets the requirements for the SFDA medical device barcodes .
The SFDA is now requiring all sponsors planning on conducting a clinical trial in Saudi Arabia to obtain approval prior to initiation. An application including data regarding the investigational device, clinical trial design, labeling information, and contact information for the manufacturer and clinical investigator must be submitted to the SFDA. The investigational medical device will not be permitted entry into the Kingdom of Saudi Arabia (KSA) without approval from the SFDA .
Effective September 1, 2015, The China Food and Drug Administration (CFDA) is planning on conducting unannounced audits of medical device manufacturers. Such audits will be triggered in the following cases:
- Quality System Noncompliance violations
- Complaints regarding device quality or safety
- Insufficient adverse event reporting
- Other Quality and/or safety risks related to a device
These unannounced audits can occur for any manufacturer whose product is registered in China . This plan is similar to the EU Commission’s recommendation that Notified Bodies conduct unannounced audits on legal manufacturers (both in the EU and outside the EU), which was released in 2013.
On December 1, 2014, Health Canada put regulations in place allowing manufacturers to submit marketing applications electronically for Class III and IV medical device license applications and license amendment applications (no paper submission required). If a paper copy submission is submitted, the format of the submission for Class III and IV devices must follow the same format as the electronic format. Health Canada Guidance . The new submission format contains different requirements than the FDA’s eCopy requirements and will require additional administrative time for manufacturers to complete.
Malaysia’s Medical Device Authority (MDA) has published two sets of guidelines establishing requirements for Field Safety and Correction actions and complaint handling. The new guidelines require medical device companies to inform the MDA of all reports of death or serious injury related to their device and to notify the MDA of any field corrective actions. A Field Safety Notice Template is also provided  .
Malaysia has extended the deadline for submission of registration applications to the Fast-Track program. The program was designed to integrate all medical devices and IVDs marketed in Malaysia into the newly designed system of regulations. Before the extension, applications were due July 1, 2015 in order for manufacturers to continue to market their devices in Malaysia. Now all applications are due June 30, 2016. The program is available to all medical devices, not just devices currently marketed in Malaysia .
India continues its trend of developing and enforcing new measures to protect patients’ welfare. India’s Drug Controller General (DCGI) is implementing a new Safety Monitoring program for Medical Devices. The program aims to create an avenue by which adverse events can be reviewed to ensure the safety and effectiveness of the associated medical devices. The Indian Pharmacopoeia Commission in Ghaziabad will coordinate the program and the reports will be reviewed by “Materio-Vigilance Program” centers in ten medical colleges across India.  The program will be formally referred to as the Materiovigilance Programme of India (MvPI) and represents a milestone in the development of medical device regulations in India. 
The Therapeutic Goods Administration (TGA) is now requiring that applications for Clinical Trials (referred to a clinical trial notification (CTNs)) be submitted in electronic form online. CTNs must be submitted to the TGA if the device or product being investigated is not registered with the Australian Register of Therapeutic Goods (ARTG) or if it is being used “outside the conditions of its marketing approval.” Sponsors should log into the TGA Business services site and use the CTN form provided to notify the TGA of clinical trials .
South Korea’s Ministry for Food and Drug Safety (MFDS) has issued a draft regulation issuing several new requirements for medical devices. Included in the regulations are expansions on clinical data requirements for implantable/invasive devices, devices used to sustain human life, absorbable devices, and devices made from special materials. MFDA is also requiring that all biocompatibility testing be conducted according to Good Laboratory practices (GLP). Also, Class I device notifications will now be submitted to the newly established Medical Device Information & Technology Assistance Center, who will then register the notification online. This will alert the applicant that the device can be legally marketed in South Korea .
The biotech industry is ever changing and growing. Regulations and rules are continuously being refined to establish better controls over medical devices and manufacturers. If companies want to continue to be compliant and maintain access to the globalized market, they must be well acquainted with the evolving regulations. Boston Biomedical Associates assists companies in remaining complaint within these markets by assisting with submissions and updating existing registrations.
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|||S. Eisenhart, “New Medical Device Barcodes Required by Saudi Regulators,” Emergo Group, 22 June 2015. [Online]. Available: http://www.emergogroup.com/blog/2015/06/new-medical-device-barcodes-required-saudi-regulators.|
|||S. Eisenhart, “Saudi Regulators Issue New Guidance on Investigational Medical Devices,” Emergo Group, 02 June 2015. [Online]. Available: http://www.emergogroup.com/blog/2015/06/saudi-regulators-issue-new-guidance-investigational-medical-devices.|
|||E. G. Stewart Eisenhart, “Chinese regulators plan surprise inspections for medical device facilities,” +MassDevice, 15 July 2015. [Online]. Available: http://www.massdevice.com/chinese-regulators-plan-surprise-inspections-for-medical-device-facilities/.|
|||Health Canada, “Notice – Guidance for Industry: Formatting of Class III and Class IV Licence Applications (Electronic and Paper Formats),” Health Canada, 10 November 2014. [Online]. Available: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_im_avis_CIII_CIV_format_mise_en_forme-eng.php.|
|||N. P. Taylor, “Malaysia Posts Draft Medical Device Guidelines (Asia Regulatory Roundup: Malaysia Posts Draft Medical Device Guidelines (7 July 2015)),” RAPs, 07 July 2015. [Online]. Available: http://raps.org/Regulatory-Focus/News/2015/07/07/22842/Asia-Regulatory-Roundup-Malaysia-Posts-Draft-Medical-Device-Guidelines-7-July-2015/.|
|||S. Eisenhart, “Malaysian Medical Device Regulators Ready Post-Marketing Requirements,” Emergo Group, 01 July 2015. [Online]. Available: http://www.emergogroup.com/blog/2015/07/malaysian-medical-device-regulators-ready-post-marketing-requirements.|
|||S. Eisenhart, “Malaysia Extends Deadline for Medical Device Registrations,” Emergo Group, 02 July 2015. [Online]. Available: http://www.emergogroup.com/blog/2015/07/malaysia-extends-deadline-medical-device-registrations.|
|||F. Densford, “India to roll out adverse event medical device monitoring,” +MassDevice, 21 May 2015. [Online]. Available: http://www.massdevice.com/india-roll-out-adverse-event-medical-device-monitoring/.|
|||S. N. Shirodkar, “Ministry of health launches MvPI to monitor safety of medical devices,” 10 July 2015. [Online]. Available: http://pharmabiz.com/ArticleDetails.aspx?aid=89344&sid=1.|
|||Therapeutic Goods Administration (TGA), “Clinical trials: New online form for CTN scheme,” Australian Government Department of Health, 1 July 2015. [Online]. Available: http://www.tga.gov.au/media-release/clinical-trials-new-online-form-ctn-scheme.|
|||S. Eisenhart, “Analysis of New Draft Regulation for Medical Devices in South Korea,” Emergo Group, 06 July 2015. [Online]. Available: http://www.emergogroup.com/blog/2015/07/analysis-new-draft-regulation-medical-devices-south-korea.|