October 5, 2021 Regulatory Updates
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Medical Devices – Asia Regulatory Updates round up – Sep 2021

China (NMDA)

1. 2th China International Medical Device Regulatory Forum held in Wuhan

Sponsored by the China Center for Food and Drug International Exchange (CCFDIE), the 12th China International Medical Device Regulatory Forum opened on Sept 24 in Wuhan, capital of Central China’s Hubei province. Hubei Deputy Governor Zhang Wenbing delivered a welcome speech. Xu Jinghe, deputy commissioner of the National Medical Products Administration (NMPA), attended and spoke at the opening ceremony.

Hong Kong (FDA)

2. The newly revised Guide No. GN-02 “Guidelines for the Listing of Class II/III/IV Medical Devices”, Guide No. GN-06 “Guidelines for the Listing of In Vitro Diagnostic Medical Devices” and related documents have been published

The following documents have been revised to the September 2021 version. All application documents delivered to this office on or after December 1, 2021 must be completed in a revised version of the application form and other applicable revised documents. Application for listing of Class II/III/IV medical devices (MD-C2&3&4).

In Vitro Diagnostic Medical Device Listing Application (MD-IVD). Guide No. GN-02: Guide to the Listing of Class II/III/IV Medical Devices. Guide No. GN-06: Guidelines for Listing of In Vitro Diagnostic Medical Devices.

Please click the “Application Form” and ” Publication Documents “pages to download the above documents. The old version has been removed from the website.

India (CDSCO)

3. Registration and Labeling requirements of Medical Devices – Regarding

F.No. 29/Misc./03/2021-DC (28) Central Drugs Standard Control Organization Government of India Ministry of Health and Family Welfare. All the States/UTs Drugs Controllers, FDA Bhawan, New Delhi Dated the September, 2021

As you are aware that, Ministry of Health & Family Welfare (MoHFW) has issued notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, as under, which is effective from 01.04 2020. The Ministry has also issued notification G.S.R 102(E) dated 11.02.2020, regarding registration requirements for such medical devices which is effective from 01.04 2020.

As per the notification, from 01.04.2020 till September 2021, such Medical Devices will be under voluntary registration scheme.

Thereafter, from October, 2021-Class A & B Medical Devices will be under compulsory registration scheme up to September- 2022 and Class C & D Medical Devices will be under compulsory registration scheme up to September-2023. Various representations have been received recently from stakeholders informing that complete preparedness of Industry in this regard remains to be achieved, in light of disruption due to COVID-19 pandemic situation.

The representations are under consideration of Ministry of Health and Family welfare, Govt. of India. You are requested to take note of the same with a view to ensure uninterrupted supply of such medical devices and access to the patients till a decision is taken on the representations.

Philippines (FDA)

4. New Validity Period of the Food and Drug Administration — Center for Device Regulation, Radiation Health, and Research (FDA-CDRRHR) Authorizations for Radiation Facilities under the One-Stop Shop (OSS) Licensing System of the Department of Health (DOH)

Subject: New Validity Period of the Food and Drug Administration — Center for Device Regulation, Radiation Health, and Research (FDA-CDRRHR) Authorizations for Radiation Facilities under the One-Stop Shop (OSS) Licensing System of the Department of Health (DOH)

Pursuant to Section VI.B.5.3 of DOH Administrative Order (AO) No. 2020-0035 or the “Rules and Regulations on the Licensing and Registration of Radiation Facilities Involved in the Use of Radiation Devices and Issuance of Other Related Authorizations,” all applications received starting October 1, 2021, for authorizations to be issued for radiation facilities under the One-Stop Shop (OSS) Licensing System of the Department of Health (DOH), shall be valid for three (3) years for initial and five (5) years for renewal applications.

The FDA-CDRRHR authorizations issued shall remain valid and shall be used as basis for the issuance of related DOH authorizations for OSS facilities pursuant to DOH AO No. 2018-0016 or the “Revised Guidelines in the Implementation of the One-Stop Shop Licensing System,” provided that no violation has been committed in relation to pertinent rules and regulations which may result in penalties or sanctions. Dissemination of this advisory to all concerned is hereby requested.

AUSTRALIA (TGA)

5. Conformity assessment certificates, changes to requirements for certain medical devices

Repeal of Regulation 4.1 of the Medical Devices Regulations

The conformity assessment certification and audit requirements for certain medical devices have changed. 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 recognise 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.

6. Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

7. Reclassification of spinal implantable medical devices

The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.

From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:

  • more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
  • conformity assessment documents demonstrating procedures appropriate for their classification
  • a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.

8. Export of therapeutic goods from Australia

To export therapeutic goods from Australia, you must meet requirements set out in the therapeutic goods legislation, in addition to other Commonwealth and State or Territory legislation. Export regulation supports the development and manufacture of Australian therapeutic goods and ensures that goods leaving Australia meet appropriate safety and quality standards to support public health.

Export of medical devices

Medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs) must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are the subject of an exemption or exclusion.

Information regarding the export of medical devices can be found in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

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