July 5, 2022
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Medical Devices – Asia Regulatory Updates Roundup, June 2022

India (CDSCO)

Final GSR 450(E)_To amend Fourth Schedule with respect to TSE or BSE certificate under MDR

In the Medical Devices Rules, 2017, in Fourth Schedule, in Part III, in Appendix II, in paragraph 7.4 relating to biological safety, in clause no. (i), the following proviso shall be inserted, namely:— “Provided that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) Certificates is not necessary, if the source is from an animal species from a country of origin recognised as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organisation for Animal Health.”

CHINA (NMPA)

China’s new regulation on the Supervising and Administration of Medical Device (the “New Regulation”) took effect on 1 June 2021. Here are the key implications

China’s new Regulation on the Supervising and Administration of Medical Device (the “New Regulation”) took effect on 1 June 2021. For more info check below link

Circular of the Center for Device Review of the State Food and Drug Administration on Issuing the Guiding Principles for the Registration Review of the Fundus Image Aided Diagnosis Software for Diabetic Retinopathy (2022 No. 23)

In order to further standardize the management of fundus image-aided diagnosis software for diabetic retinopathy, the Device Review Center of the State Food and Drug Administration organized and formulated the Guidelines for Registration and Review of Fundus Image-aided Diagnosis Software for Diabetic Retinopathy, which is hereby issued.

Circular of the State Food and Drug Administration on Issuing 6 Guiding Principles Including the Guiding Principles for the Naming of Active Surgical Devices Generic Names (No. 26 of 2022)

In order to further standardize the common names of medical devices and strengthen the management of the whole life cycle of medical devices, the State Drug Administration organized the formulation of the “Guidelines for Naming Common Names of Active Surgical Devices”, “Guidelines for Naming Common Names of Physical Therapy Devices”, and “Generic Names for Patient-carrying Devices”. The Guidelines for Naming Names, the Guidelines for Naming Common Names of Ophthalmic Devices, and the Guidelines for Naming Common Names of Infusion, Nursing and Protective Devices, and the Guidelines for Naming Common Names of Clinical Inspection Devices are hereby issued.

SOUTH KOREA (MFDS)

Ministry of Food and Drug Safety promotes international standardization of performance evaluation to increase accuracy of medical devices

Ministry of Food and Drug Safety promotes international standardization of performance evaluation to increase medical device accuracy

MALAYSIA (MDA)

Requirements for Labelling of Medical Devices

This guidance to all medical devices except those that are exempted from registration as per Medical Device (Exemptions) Order 2016 and Circular Letter No. 4/2018 Exemption from Registration Requirement for Export Only Medical Device.

Guideline for Re-registration of Registered Medical Device

The guideline covers all medical device classes and it is applicable to any persons who are required by the Act to register the medical devices. The document prescribes requirements for re-registration of registered medical devices for near expiry or expired medical device registration applications.

SAUDI ARABIA (SFDA)

MDS – REQ 7 Requirements for Unique Device Identification (UDI)for Medical Devices

The requirements apply to the all medical devices and medical supplies and accessories that are intended to be placed on the Kingdom of Saudi Arabia market and not exempted from marketing authorization requirements.

BAHRAIN (NHRA)

Circular No. (22) 2022: To All Medical Devices importers – Mandatory of using QR Code for Reporting Medical Devices Complaints

NHRA would like to point out the mandatory of using the QR code shown below and the necessity to ensure it is placed in a clear visible place for easy reporting of complains related to the medical devices to ensure the quality of medical devices and safety of patients and users.

AUSTRALIA (TGA)

Uniform recall procedure for therapeutic goods (URPTG)

The TGA has published a new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG).
For more information, please find the link below.

https://www.tga.gov.au/sites/default/files/uniform-recall-procedure-therapeutic-goods-urptg.pdf

Clinical evidence guidelines: Medical Devices

These guidelines provide details on the clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), under Australian legislation. For IVDs, there is also a supplementary document titled ‘Clinical evidence guidelines supplement.

New Zealand (MEDSAFE)

Schedule of Fees Payable under the Medicines Act 1981

Licences and other Fees

Medical Devices – Regulatory Statements to Foreign Governments (per statement) – $186
For more information, please find the link below.

https://www.medsafe.govt.nz/regulatory/fees.asp

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