Philippines(FDA)
1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the Philippines
These circular outlines regulatory expectations for establishments identified as medical device retailers.
Key objectives include:
- Defining which establishments fall under the category of medical device retailers
- Providing clarity on licensing requirements for drug outlets that also retail medical devices
- Specifying qualifications and responsibilities of designated personnel working in retail medical device establishments
- Detailing post-licensing inspection processes for medical device retailers
Comprehensive information on the scope, objectives, and requirements is available through the official reference link.
2.FDA Circular No.2021-0023 || Extension of Validity of Selected Special Certification for COVID-19 Test Kits under FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19”
On 12 March 2020, FDA Memorandum No. 2020-006 introduced special certification procedures for imported COVID-19 in-vitro diagnostic test kits.
Additional performance standards were issued under FDA Memorandum No. 2021-009 on 23 March 2021, which also set a six-month validity period for these certifications, originally expiring 23 September 2021.
To maintain market availability of COVID-19 test kits during the ongoing pandemic, this circular extends the validity of selected certifications issued under the earlier memorandum.
China(NMPA)
3. Forum held to boost medical device standardization
On 14 October, the NMPA hosted the China Medical Device Standards Forum in Beijing in recognition of World Standards Day.
With the theme “Better standards make for higher-quality medical devices”, the event focused on strengthening medical device standardization to support regulatory oversight and industry growth.
China currently maintains 1,835 medical device standards, covering nearly all technical segments. During the forum, the first list of ten exemplary enterprises demonstrating strong implementation of standards was announced.
In parallel, the 7th IEC International Medical Device Standards Forum was held in Shenzhen, highlighting global perspectives on medical device standards in the age of innovation.
japan(PMDA)
4.MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021)
The Ministry of Health, Labour and Welfare publishes Pharmaceuticals and Medical Devices Safety Information (PMDSI) to promote safer use of healthcare products.
These updates compile safety insights and are accessible through both the PMDA and MHLW websites, supporting healthcare providers in informed decision-making.
Thailand (FDA)
5.Thailand FDA – HSA Singapore Regulatory Reliance
Thailand FDA has implemented a regulatory reliance mechanism that leverages evaluations conducted by Singapore’s Health Sciences Authority.
This accelerated pathway allows manufacturers and importers to shorten registration timelines, as Thai regulators reference HSA’s review outcomes when assessing device safety and performance.
India (CDSCO)
6.Notice regarding Review of regulatory regime for drug approval
F. No. 12-01/21-DC (Pt-306 – XXXVI- MDTL) Government of India:
To expand national testing capabilities for medical devices, CDSCO is considering the registration and empanelment of qualified laboratories under the Medical Devices Rules, 2017.
Laboratories accredited by NABL with testing capacity for medical devices are invited to submit interest, along with details of device categories and testing competencies, for further evaluation.
AUSTRALIA (TGA)
7.Submissions received: Proposed refinements to the requirements for medical device patient information materials
TGA has reviewed submissions regarding proposed refinements to requirements for patient implant cards (PICs) and patient information leaflets (PILs) for implantable medical devices.
These requirements have been phased in since 2018 to ensure patients receive essential device information.
8.Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia
As part of ongoing regulatory reforms, TGA has released a discussion paper seeking input on mandatory adverse event reporting requirements for healthcare facilities.
This initiative aims to enhance reporting consistency and strengthen patient safety through improved device monitoring.
9.Information for medical practitioners on pending up-classification of surgical mesh devices
Healthcare providers and hospitals are advised of potential supply interruptions for certain surgical mesh devices from 1 December 2021, due to reclassification requirements.
Some sponsors may face challenges demonstrating compliance with Australian safety and performance standards, which could temporarily affect product availability.
