Final GSR 19(E)_Amendment in rules 19B, 19C,19D &19E of MDR 2017
The Government of India has given medical device manufacturers more time to apply for International Organization for Standardization (ISO) certificates covering their quality management systems.
The government released draft amendments to the Medical Devices Rules, 2017, that would have required manufacturers to file for ISO 13485 certificates by 30 November 2021. Manufacturers that filed by then would have until 31 May 2022 to obtain the certificate. The latest update extends the deadline for filing while retaining the deadline for obtaining the certificate.
Implementation of following Amendment Rules,
1. (1) These rules may be called the Medical Devices (Amendment) Rules, 2022.
(2) These rules shall come into force on the date of their publication in the Official Gazette.
2. In the Medical Devices Rules, 2017 in rule 19B, in sub-rule (2), in item (iii) and in rule 19D, in sub-rule (2), in item (iii), Proviso and Explanation shall be inserted.
3. In rule 19C and 19E for the words shall mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022; thereafter it shall be mandatory for all registration holders.
The Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022)
These rules may be called ‘The Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2021.
These rules to give advice to a licensee acting as manufacturer of drugs or medical devices, registration holder, or enlistment holder of alternative medicines, nutraceutical and health products, or CRO, clinical trial site, BA and BE center or laboratory in accordance with good practices compliance (GXP) i.e. cGMP, GCP, GDP, GVP, GLP etc., with a view to improve the standards of manufacturing, quality, efficacy and safety of therapeutic goods;
Announcement of the State Food and Drug Administration on Issuing 2 Guiding Principles for Registration Review of Drug-Device Combination Products Mainly Used as Medical Devices (No. 3 of 2022)
In order to strengthen the supervision and guidance on the registration of drug-device combination products, further encourage the listing of drug-device combination products with clinical value, and build a management model for drug-device combination products suitable for my country’s national conditions, the State Drug Administration regards the technical evaluation of drug-device combination products as a regulatory science. Research projects, organized the formulation of the “Guidelines for the Registration and Review of Drug-device Combination Products Based on the Role of Medical Devices” and “Guidelines for the Registration and Review of Drug Qualitative Quantitative and In vitro Release Research in Drug-device Combination Products Based on the Role of Medical Devices”, which are hereby released.
Announcement of the State Food and Drug Administration on the release of 3 medical device industry standards including YY 9706.274-2022 “Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment” (2022 No. 6)
Three medical device industry standards including YY 9706.274-2022 “Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment” have been approved and are now published. See the attachment for the standard number, name, scope of application and implementation date.
Announcement of the State Food and Drug Administration on Issuing the Supplementary Inspection Methods for the Identification and Content Determination of 17 Chemical Drugs in Patch Medical Devices (No. 12 of 2022)
According to Article 76 of the “Regulations on the Supervision and Administration of Medical Devices”, the State Food and Drug Administration has reviewed and approved the “Supplementary Test Methods for the Identification and Content Determination of 17 Chemical Drugs in Stick-on Medical Devices”, which is hereby issued.
Attachment: Supplementary Inspection Methods for Identification and Content Determination of 17 Chemical Drugs in Patched Medical Devices
PMDA has posted a brief consultation schedule for March regarding Medical devices and IVDs
PMDA has updated the consultation process in the month of March. The details like consultation categories Fees etc. for medical devices and IVDs is listed
PMDA has posted an updated information on clinical trials conducted from a humanitarian point of view (pharmaceutical products, equipment / regeneration)
PMDA has updated the guidelines regarding unapproved drugs, unapproved devices and unapproved regenerative medicine products (hereinafter referred to as “unapproved drugs”) for the treatment of diseases that have a significant life-threatening effect and for which existing treatments are not effective. Etc.) ”), On the premise that the development of the drug, etc. will not be hindered while balancing the risks and expected therapeutic benefits of the use of the unapproved drug, etc. In order to secure access from these patients, a system has been introduced to provide unapproved drugs, etc. from a humanitarian point of view to patients who do not meet the criteria for participation in the clinical trial.
SOUTH KOREA (MFDS)
Designation status of clinical performance testing institution
Ministry of Food and Drug Safety Notice No. 2022-62:In accordance with Article 8 of the In Vitro Diagnostic Medical Devices Act and Article 20 of the Enforcement Regulations of the same Act, the ‘Status of Designation of Clinical Performance Testing Institutions (202.01.24) is posted as an attachment.
HONG KONG (MDACS)
The regularisation of the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications
Subsequent to the trails, the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications will continue on a regular basis. Details of the said Scheme are given in the application form MD-C2&3&4 2022 Edition.
Announcement of the changes to the respective trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)
The Medical Device Division (MDD) now accepts on a regular basis the marketing approvals obtained from the National Medical Products Administration (NMPA) as a proof of compliance of Class II/III/IV General Medical Device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under the MDACS. Also, the acceptance of the marketing approval is extended to cover In Vitro Diagnostic Medical Devices (IVDMD) on trial basis until 31 December 2022.
MDACS Activities – Update of Guidance Notes GN-02, GN-06 and related Application Forms
Medical Device Administrative Control System (MDACS) has updated guidance notes for Medical device listing. The following documents that are listed below are now made available on the Website
1. Guidance Notes: GN-02Guidance Notes for Listing Class II/III/IV General Medical Devices
2. Guidance Notes: GN-06 Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices
3. Application for the Listing of Class II/III/IV General Medical Devices
4. Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD)
5. Note for the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications
Advisory Committee on Medical Devices (ACMD)
Membership update to the seven Statutory Advisory Committees.
Role of the ACMD
The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, performance and manufacturing of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post-market monitoring.
WARNING: No special exemptions to import or supply unapproved rapid antigen tests have been granted by the TGA
The Therapeutic Goods Administration (TGA) in collaboration with the Australian Federal Police (AFP) is investigating false documentation allegedly used to support the illegal importation and supply of unapproved rapid antigen tests for COVID-19.
No special exemptions to import or supply unapproved rapid antigen tests have been granted by the TGA.