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In the years, ahead Asia might see a surge in the growth of medical device industry. Globally there has been a rise in the export of product and technologies from Asia. Diversity within this continent poses a great challenge towards creating a harmonized regulation for medical devices.
Regulatory reforms are necessary as they offer room for innovation and increases efficiency. Simultaneous cost reductions have a positive impact on the national economy and keeps the competition alive allowing the companies to adapt with the changes. Once undertaken, a regulatory reform can aid in bringing about several other reform policies apt for the nation.
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The European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.
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745A(b) of the Federal Food, Drug,and Cosmetic Act (FD&C Act), amended by section 207of the FDA Reauthorization Act of 2017(FDARA) (Pub. L. 115-52), requires thatpre-submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, and any supplementsto such pre-submissions or submissions, including appeals of those submissions, be submitted in electronic format specified by the Food and Drug Administration (FDA or the Agency)beginning on such date as specified by FDA in final guidance.
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Latest Medical Device Regulatory updates - July 2020
Communication concerning the return of deposits and the evaluation of advertising visas for pharmaceutical specialties, medical devices and in vitro diagnostic medical devices - Information Point
Regarding DM and DMDIV advertising visas
For DMs and DMDIVs whose advertising must be subject to a prior authorization request, the filing of these advertising requests can be made at any time during the year. The ANSM has a period of 2 months, from the date of receipt of the complete file, to authorize publicity or notify the applicant of a reasoned refusal. Beyond this period and without response from the ANSM, the request is deemed accepted.
For requests whose evaluation was to end during the legally protected period (from March 12 to June 23, 2020 inclusive), the evaluation period is suspended and resumes its course, for the remaining period, from 24 June 2020. The absence of an Agency decision at the end of this period will constitute implied authorization.
For requests whose evaluation was to start and expire during the legally protected period, the starting point of the evaluation period is postponed, for the initial period of 2 months, to June 24, 2020. These requests will be deemed to have been accepted in no decision as of August 24, 2020.
Regarding expiring advertising visas
Provided that no decision modifying them or terminating has been pronounced, advertising visas the validity period to expire between 12 March and 1st December 2020 are extended by right until 31 December 2020.
Latest Drug Regulatory updates - July 2020
European Commission to Propose Relaxation of GMO Regulations for COVID-19 Vaccines
European Commission (EC) proposed relaxation to regulations of genetically modified organisms (GMOs)to ensure that clinical trials with medicinal products for human use that contain or consist of GMO's and are intended to treat or prevent COVID-19.
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