Country	Organization	Document	Status
International	IMDRF	Post-Market Clinical Follow-Up Studies (IMDRF MDCE WG/N65FINAL:2021)	Final
Canada	HC	Canada’s approach to onsite inspections during COVID-19: Notice	Final
Canada	HC	Notice: Technical requirements for anti-microbial claims for medical masks	Final
EU	MDCG	MDCG 2021-6: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation	Final
EU	MDCG	MDCG 2021-4: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2018-1 Rev.4: Guidance on BASIC UDI-DI and changes to UDI-DI	Final
EU	MDCG	MDCG 2021-5: Guidance on standardisation for medical devices	Final
EU	MDCG	Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Final
India	CDSCO	Supply of essential In-Vitro Diagnostic testing reagents/kits for inflammatory markers such as IL-6 (Interleukin 6), D-Dimer and C-reactive protein (CRP)	Final
India	CDSCO	Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021	Final
Malaysia	MDA	Guideline application for medical device advertisement approval – Requirements (MDA/GL/04)	Final
Malaysia	MDA	Second edition guidance document MDA/GD/0032: Code of Advertisement (COA) (MDA/GD/0032)	Final
Malaysia	MDA	Medical Device-Drug-Cosmetic Interphase (MDDCI) Products Revision 2021	Final
Netherlands	MEB	Medical Devices Regulation: additional information about the procedure for medical devices	Final
Philippines	FDA Philippines	List of Class A Medical Devices	Draft
Philippines	FDA Philippines	Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”	Draft
Philippines	FDA Philippines	Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems	Draft
Philippines	FDA Philippines	FDA Circular No.2020-0022-B - Amendment to include health products from the COVAX facility/World Health Organization to the list of identified donated health products under the scope of FDA Circular No. 2020-022	Final
Saudi Arabia	Saudi FDA	Guidance on Review and Approval of Artificial Intelligence (AI) and Big Data based Medical Devices (MDS – G53)	Final
Saudi Arabia	Saudi FDA	Extending of work procedures for Medical Device Marketing Authorization (MDMA) requests until the medical device law comes into effect	Final
Saudi Arabia	Saudi FDA	Products Classification Guidance (Version 5.0)	Final
Singapore	HSA	GN-15: Guidance on Medical Device Product Registration (Revision 7.4)	Final
Singapore	HSA	GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices (Revision 4.3)	Final
Singapore	HSA	GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration (Revision 7.4)	Final
Singapore	HSA	GN-21: Guidance on Change Notification for Registered Medical Devices (Revision 4.8)	Final
Singapore	HSA	GN-24: Guidance on the Change of Registrant (Revision 1.4)	Final
Singapore	HSA	ANNEX 1 GN-24-R1.4 Guidance on the Change of Registrant - Letter of Request Template	Final
Singapore	HSA	ANNEX 2 GN-24-R1.4 Guidance on the Change of Registrant - Relinquishing Company Declaration Form	Final
South Korea	MFDS	Notice - New Guidance on Usability Requirements for Medical Device Manufacturers	Final
UK	MHRA	Medical devices: EU regulations for MDR and IVDR (Northern Ireland)	Final
UK	MHRA	Export medical devices	Final
UK	MHRA	Regulatory status of equipment being used to help prevent coronavirus (COVID-19)	Final

Global Medtech Guidance Tracker: April 2021

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