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Guideline: Classification of Active Medical Devices (Including Software-Based Medical Devices), Version 1.0, Oct-2021. There are several classification rules for active medical devices that may apply depending on the intended purpose of the device. This guidance document has been recently issued to assist manufacturers and Australia sponsor to correctly identify the classifications rules and the required conformity assessment procedure to be applied.

 

Frequently Asked Questions: Conformity Assessment Certificates, Changes to Requirements for Certain Medical Devices; Repeal of Regulation 4.1 of the Medical Devices Regulations, 17-Sep-2021. On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002.This means that from 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices no longer require mandatory TGA conformity assessment certification. Now sponsors can provide conformity assessment documents issued by notified bodies designated by a member state of the European Union to support an application for inclusion in the ARTG. These changes recognize the significantly enhanced standards, processes and clinical evaluation requirements contained in the European Union's (EU) Regulations for Medical Devices and In Vitro Diagnostics. It is important to note that Australia has some different regulatory requirements to Europe (e.g.: biologicals) and therefore, the amendment to Regulation 5.3 provides for the TGA to audit applications to ensure the information provided meets the Australian regulatory requirements. This ensures that safety and performance is demonstrated prior to approving the device for supply in Australia.

 

Guidance: Completing an Application for Consent to Import, Supply or Export a Medical Device that does not Comply with the Essential Principles, Version 1.0, Oct-2021. The Australian TGA expects compliance with the Essential Principles, however there may be some extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period. This guidance document assists applicants on how to complete the Application form for consent for devices that do not comply with Essential Principles 13A related to patient information material and provision of Patient Implant card and Patient Information Leaflet.

NMPA Notification on Issuing the catalogue of Medical Device Exempt from Clinical Evaluations (No 71, 20210). NMPA organized to formulate the Catalogue of Medical Device Exempt from Clinical evaluations in accordance with the SAMR Order 47 the administrative measures for the registration and filing of medical device. This notification will come into force as of Oct. 1 2021.

 

NMPA Notification No.2021/70: Issuance on the Catalog of In-vitro Diagnostics Reagents (IVDs) Exempted from Clinical Trials, 16-Sep-2021. Based on Provisions for Medical Device Registration and Filing, NMPA elaborated the catalog of IVDs that are exempted from clinical evaluation. This document will come into force starting from 01-Oct-2021. This catalog (2021) includes the product classification reference number, product name and the product description. This document replaces part of the NMPA Notification: Summary List of Medical Devices Exempted from Clinical Trials, 23-Dec-2019 and NMPA Notification No.2019/91: Issuance of the New and Revised Catalogs of Medical Devices Exempted from Clinical Trials, 13-Dec-2019.

 

CMDE Explanatory Note on the Provisions on Self-inspection for Medical Device Registration, 28-Oct-2021. This document provides the explanatory notes on the recent published CMDE Announcement No.2021/126: Issuance of Provisions on Self-inspection for Medical Device Registration, 21-Oct-2021. This document includes: 1. Formulation background 2. Main content of the Provisions on Self-inspection for Medical Device Registration 3. Explanation of key issues.

 

CMDE Announcement No.2021/126: Issuance of Provisions on Self-inspection for Medical Device Registration, 21-Oct-2021. This document issues the Provisions on Self-inspection for Medical Device Registration, which comes into force since the issuance date. This document includes the requirements for self-inspection abilities, the requirements for self-inspection reports, the requirements for entrusted testing, the requirements for application dossiers, the requirements for on-site inspections and the requirements for responsibilities. The three annexes are: 1) Sample of the self-inspection report of the medical device registration, 2) Information sheet of settings of equipment for testing use, 3) Information sheet of testing personnel. This document replaces NMPA Soliciting Public Comment on Provisions on Self-inspection of Medical Device Registration (Draft), 01-Jun-2021. 

 

NMPA, NHC & NHSA Announcement No.2021/114: Implementation of Medical Device Unique Identification Related Work on the Second Batch of Medical Devices, 14-Sep-2021. Starting from 01-Jan-2021, the unique identification has been implemented to the first batch of 69 medical devices. Now the NMPA, NHC & NHSA notify to carry out the implementation work of the unique identification on the second batch of medical devices (the other medical devices of Class III which were not included in the first batch). The impacted types of products, implementation time and relevant requirements are included in this document.

 

NMPA Announcement No.2021/129: Issuance of In-vitro Diagnostic (IVD) Reagents Classification Regulations, 27-Oct-2021. This document provides the regulations about the classification of the in-vitro diagnostic (IVD) reagents. It contains the definitions, the classification rules based on the risks, and criteria for IVD reagents classification.

 

NMPA Order No.48: Provisions for In-vitro Diagnostics Reagents (IVD) Registration and Filing, 26-Aug-2021. This document issues the revised version of Provisions for In-vitro Diagnostics Reagents Registration and Filing. This document includes ten chapters (125 articles): Chapter 1: General provisions Chapter 2: Basic requirements Chapter 3: IVD registration Chapter 4: Special registration procedures Chapter 5: Registration variations and renewal Chapter 6: IVD filing Chapter 7: Timelines Chapter 8: Supervision and administration Chapter 9: Legal liability Chapter 10: Supplementary provision. This document replaces NMPA Notification: Soliciting Public Comment on Provision for the Registration of In Vitro Diagnostic Reagents (Revised Version) (Draft), 26-Mar-2021 and CFDA Order No. 5: Provision for the Registration of In Vitro Diagnostic Reagents, 30-Jul-2014.

 

NMPA Order No.47: Provisions for Medical Device Registration and Filing, 26-Aug-2021. This document aims to issue the revised version of Provisions for Medical Device Registration and Filing.  This document includes ten chapters (125 articles): Chapter 1: General provisions Chapter 2: Basic requirements Chapter 3: Medical device registration Chapter 4: Special registration procedures Chapter 5: Registration variations and renewal Chapter 6: Medical device filing Chapter 7: Timelines Chapter 8: Supervision and administration Chapter 9: Legal liability Chapter 10: Supplementary provision. Compared to the previous version, this revision has: Implemented the central government’s reform requirements on review and approval system. Implemented the “Four Most Stringent” requirements. Implemented the requirements on reform to “Delegate power, streamline administration and optimize government services”. Optimized the scientific and efficient review and approval procedures. This document replaces CFDA Order No. 4: Provisions for Medical Device Registration, 30-Jul-2014 and NMPA Notification: Soliciting Public Comment on Provision for the Registration of Medical Devices (Revised Version) (Draft), 26-Mar-2021.

CDSCO Notice No. 29/Misc./3/2020-DC(178): Classification of Medical Devices pertaining to Pain Management under the Provisions of Medical Devices Rules, 2017-Reg, 13-Sep-2021. CDSCO under provisions of Medical Devices Rules 2017 has classified 26 medical devices related to Pain Management. Applicants now can refer to this classification for guidance while submitting registration application.

 

CDSCO Notice No. 29/Misc./3/2020-DC(198): Classification of Medical Devices pertaining to Software under the Provisions of Medical Devices Rules, 2017-Reg, 13-Sep-2021. CDSCO under provisions of Medical Devices Rules 2017 has classified 60 medical devices related to Software. Applicants now can refer to this classification for guidance while submitting registration application.

 

CDSCO issued guidance document for registration of non-notified medical devices under provisions of Medical Devices Rules 2017. Importers/manufacturers can follow this guidance for registering the products.

 

CDSCO Notice No. 29/Misc./3/2020-DC(193): Classification of Medical Devices pertaining to General Hospital under the Provisions of Medical Devices Rules, 2017-Reg, 13-Sep-2021. CDSCO under provisions of Medical Devices Rules 2017 has classified 57 medical devices related to General Hospital. Applicants now can refer to this classification for guidance while submitting registration application.

 

CDSCO Notice No. 29/Misc./3/2020-DC(186): Classification of Medical Devices pertaining to Personal Protective Equipment under the Provisions of Medical Devices Rules, 2017-Reg, 13-Sep-2021. CDSCO under provisions of Medical Devices Rules 2017 has classified 32 medical devices related to Personal Protective Equipment. Applicants now can refer to this classification for guidance while submitting registration application.

 

CDSCO Notice No. 29/Misc./3/2020-DC(143): Classification of Medical Devices pertaining to Nephrology and Renal Care under the Provisions of Medical Devices Rules, 2017-Reg, 13-Sep-2021. CDSCO under provisions of Medical Devices Rules 2017 has classified 44 medical devices related to Nephrology and Renal Care. Applicants now can refer to this classification for guidance while submitting registration application.

 

Classification of various medical device categories - In accordance with the intended use, risk associated with the device, and other parameters specified in the First Schedule of the Medical Devices Rules-2017, the Drugs Controller General of India (DCGI), Directorate General of Health Services, India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO), has classified medical devices pertaining to various categories such as Nephrology and Renal Care, General Hospital, Personal Protective Equipment, Software, Pain Management, Urology, Obstetrical and Gynecological, Pediatrics and Neonatology, Dental, Anesthesiology, Deontological & Plastic Surgery, Interventional Radiology, Physical Support, Rehabilitation, Cardiovascular, In-vitro Diagnostic Medical Devices.

Newsletter: PMDA Updates, Oct-2021.PMDA announced News letter on their recent activities. PMDA reported successfully held Malaysia-Japan Bilateral meeting, virtual IMDRF management committee meeting, etc. We can see their many kinds of activities among the ASPAC area.

Guideline For Registration of Drug-Medical Device And Medical Device-Drug Combination Products 4th Edition 2021. This revised guideline has been updated to include the latest requirement for submission of registration application of combination products and change/variation application.

 

Guideline MDA/GL/05 - Guidelines for implementation of medical device regulatory system - Conditional Approval For Covid-19 Rapid Test Kit (Self-Test), First Edition, July 2021.This Guideline Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. This Guideline Document shall be read in conjunction with the current laws and regulations used in Malaysia. It provides clarification on Covid-19 self-test kit that are regulated under the Medical Device Act (Act 737), and it is applicable to establishments, healthcare facilities, and public dealing with Covid-19 self-test kits. Conditional approval application is to be submitted via email at: ca.covid19@mdb.gov.my using the Form A in Annex A. Section 4 on "Application Procedure" provides the list of required documentation to be submitted as part of this application, along with the applicable fees, and the procedure flowchart.

Online submission of License Applications of Medical Devices. Drug Regulatory Authority of Pakistan has developed an online system for processing of applications of establishment license to import or manufacture medical devices. The portal is for new applicants as well as for renewal applications of establishment license.

Guideline: Guide-0636-05: Guidance on the Regulation on License, Declaration and Review of In Vitro Diagnostic Devices, 17-Sep-2021.This document is revised guidance on the Provision on License, Declaration and Review of In Vitro Diagnostic Devices. The guidance is aimed to ensure proper management of in vitro diagnostic devices for marketing and importing in compliance with the relevant regulations of In Vitro Diagnostic Devices Act, Enforcement Regulations of the In Vitro Diagnostic Medical Device Act, etc.

Exemptions for medicine and devices- to all marketing authorization holder.NMRA has provided exemption to file application as per rule 64 (1) of NMRA act (which mandates filing renewal 6 month prior to expiry of license) where in if the expiry of the registration certificate (extended registration certificate) falls between 02nd September 2021 to 01st March 2022, section 64(1) of the NMRA act no.05 0f 2015 will not be considered when submitting the renewal dossiers or additional documents. NMRA will accept re-registration application manually for routine process which is not covered by above.

TFDA Announcement No.1101604205: Guidance on Clinical Performance Studies of In Vitro Diagnostic Medical Devices (IVDs), 19-Oct-2021.This document provides the Guidance on Clinical Performance Studies of In Vitro Diagnostic Medical Devices. This guidance includes the following information: 1. Introduction 2. (Applicable) scope 3. Definitions 4. Clinical performance study plan 5. First research organizations 6. Execution of clinical performance studies 7. Closure of the clinical performance studies 8. Reference 9. Annexes.

Thailand FDA - Singapore HSA Regulatory Reliance. Thailand FDA - Singapore HSA Regulatory Reliance is expedited medical device registration program that the manufacturer or importer can request for faster registration turn-around in Thailand based on the results of the safety and performance assessment from the Health Science Authority, Singapore. With this program, the duration of the registration approval is expected to be completed within 60 business days (3 months) compared to the regular route, in case of sending to experts, working groups or subcommittee for evaluation, which take 150 working days (7 months and a half).

 

 

Conditions for participating: