A Global Perspective of Clinical Trial and Regulatory Changes around the World

A Global Perspective of Clinical Trial and Regulatory Changes around the World

Medical Device and Pharmaceutical rules and regulations are constantly evolving. This issue of the BBA ENewsletter offers a quick update on recent changes to the regulatory landscape.


On March 20, 2013 the CFDA released two draft proposals for new medical device regulations. The first is titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) and offers an opportunity for Chinese based manufacturers and inventors to have their device approval process streamlined. The second, Regulation for Simplification of Application Materials Required for Medical Device License Re-registration (Interim) (draft) makes the re-registration process easier in that if no changes have occurred in terms of safety, efficacy, or function, then the applicant does not need to provide test, reports, product standards, or operations manuals. In addition if changes have been made to a medical device, only technical documentation related to those specific alterations is required to be submitted. [1]

On September 6, 2013 The CFDA announced that they will be requiring registration of all clinical trials and bioequivalence studies (phases I, II, III, IV). [2]


According to the Emergo Group, ANVISA, Brazil’s medical device regulator, is planning a major overhaul of its medical device regulations. ANVISA has issued a list of topics to be addressed, including, but not limited to:

  •     New regulatory requirements specifically for medical device software
  •     Modification of RDC 25/2009 regarding which classes of devices require Brazil Good Manufacturing Practice (BGMP) quality system certification
  •     Updated grouping and classification criteria for IVD products
  •     Updated regulations for orthopedic implant devices
  •     Updated regulations for transfers of registration. [4]

Costa Rica

The Costa Rican Ministry of Health announced its intention to begin accepting medical device registrations online in late 2013. Medical device manufacturers attempting to obtain Costa Ricans market authorization will be able to do so with a digital registration application. [3]


Roszdravnadzor officials, Russia’s medical device regulators, have announced that they will be issuing new guidelines to address the Safety, quality, and effectiveness of In Vitro Diagnostic devices. This comes on the heels of yet another announcement that Russian regulators are attempting to simplify the medical device registration process and ease up on re-registration requirements. The officials also stated that they aim to make safe and effective medical devices more readily available to the Russian population. [5] [6]


The Medical Device Authority of Malaysia has issued a six-step guideline regarding web-based medical device registration. MEDCAST (Medical Device Centralized Online Application System) launched in July, and the guidance issued provides instructions on determining whether a device is a medical device under the 2012 Malaysian device law as well as on device classification and grouping. The guidance also instructs companies to conduct an assessment to ensure that their device conforms with MDA regulations. [7]



Effective September 16, 2013, all class I low-risk medical devices are exempt from Good Manufacturing Practices (GMP) by the The Korean Ministry of Food and Drug Safety (MFDS). Before this date all devices had to comply with GMP requirements to obtain market authorization. [8]


In early 2013, a draft report was released by the European Parliament’ Committee on Environment, Public health, and Food Safety (ENVI). The report proposed sweeping changes for Medical Device and In vitro diagnostic regulations. The changes include (but are not limited to) the creation of a centralized marketing procedure for implantable medical devices, labeling requirements, and a new class system for medical device regulation (similar to the system in place in the US).

In response to this proposal, the industry, and most notably Eucomed (a medical device trade group) has lashed out, claiming that the plan will stifle innovation and delay patient access to new life saving technologies. In order to support their position, Euromed release a survey showing that the proposal could cost the industry an estimated €25 billion. These costs were grouped into five main areas:

  •     Required clinical data
  •     Increased length and cost of the approval process
  •     Labeling for future new CE marks
  •     Re-use labeling
  •     Administrative implications (inputting data into central databases, etc).


The Regulations and Laws that dictate the how, when, and where of Medical Devices and Combination Products are constantly changing across the globe. It can be tricky to navigate around these regulations. This is where Boston Biomedical Associates comes in. We are here to help keep you informed and prepared. We can assist your company to bring your devices to the global market. We will guide you through each step of the regulatory pathway, from product development to pre and post market notifications. Please, feel free to contact us at any time.


Download the December 2013 Regulatory ENewsletter.

Stay tuned for our next E Newsletter, and please follow us on twitter @BBACRO


[1]       N. Lou, “CFDA Issues Proposed Regulations on Medical Devices,” 12 April 2013. [Online]. Available: http://www.insidemedicaldevices.com/2013/04/12/cfda-issues-proposed-regulations-on-medical-devices/. [Accessed 2013].

[2]       A. Helmanis, “China to Require Registration of all Clinical Trials, Bioequivalence Studies,” 19 September 2013. [Online]. Available: http://www.raps.org/focus-online/news/news-article-view/article/4097/china-to-require-registration-of-all-clinical-trials-bioequivalence-studies.aspx. [Accessed 19 September 2013].

[3]       S. Eisenhart, “Digital Registration in the Works for Costa Rican Medical Device Market,” 11 September 2013. [Online]. Available: http://www.emergogroup.com/blog/2013/09/digital-registration-works-costa-rican-medical-device-market. [Accessed 3 October 2013].

[4]       S. Eisenhart, “ANVISA Unveils Ambitious Overhaul Plans for Medical Device Regulations,” 11 September 2013. [Online]. Available: http://www.emergogroup.com/blog/2013/09/anvisa-unveils-ambitious-overhaul-plans-medical-device-regulations.

[5]       S. Eisenhart, “Possible Thaw in Russian Medical Device Regulations?,” 6 September 2013. [Online]. Available: http://www.emergogroup.com/blog/2013/09/possible-thaw-russian-medical-device-regulations.

[6]       S. Eisenhart, “Russian Regulators Plan New Guidelines for IVDs,” 9 September 2013. [Online]. Available: http://www.emergogroup.com/blog/2013/09/russian-regulators-plan-new-guidelines-ivds.

[7]       FDA News, “Malaysia Issues Final Guideline on Device Registration,” 2013 September 2013. [Online]. Available: http://fdanews.com/newsletter/article?issueId=17157&articleId=158688.

[8]       S. Eisenhart, “All Class I Devices Now Exempt from Korea GMP Requirements,” 9 October 2013. [Online]. Available: http://www.emergogroup.com/blog/2013/10/all-class-i-devices-now-exempt-korea-gmp-requirements?utm_source=RADAR&utm_medium=newsletter&utm_term=2pm&utm_content=Worldwide&utm_campaign=10October2013.

[9]       A. Gaffney, “Industry Group: EU Device Regulatory Proposals Would Cost ‘Outrageous’ €25 Billion,” 12 September 2013. [Online].  Available: http://www.raps.org/focus-online/news/news-article-view/article/4070.aspx.

Mack Rubley


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