Dear APACMed Members, We are pleased to present the May 2021 issue of Asia Pacific MedTech Regulatory Intelligence Watch, brought to you by our Regulatory Intelligence Working Group in partnership with Cortellis.
Sincere thanks to the Editorial Committee and Working Group for their contributions to this newsletter which aims to provide timely regulatory updates and actionable insights for markets across Asia Pacific.
Please feel free to contact us directly for any further information or questions. Best wishes, APACMed Secretariat |
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On 12th May, TGA issued Notice: Medical Devices Reforms: Reclassification of Certain Medical Devices. The TGA is considering certain devices and their current classification - particularly where there have been safety issues identified and/or where the European Union has made changes to its classification systems. “Our aim is to where possible and appropriate, harmonise the Australian classification rules to safeguard patients, harmonise requirements, facilitate smooth operation of the market and ensure timely access to medical devices. In early 2019, the TGA undertook public consultations on proposals to reclassify a number of categories of medical devices so that they align, wherever possible, with the changes being introduced in European Union (EU) medical devices framework.
The Therapeutic Goods Legislation Amendment Regulations were made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six categories of medical devices:
- Spinal implantable medical devices
- Active medical devices for therapy with diagnostic function
- Active implantable medical devices and their accessories
- Medical devices that administer medicines or biologicals by inhalation
- Medical devices that consist of substances introduced into the body via a body orifice or applied to the skin
- Medical devices used in direct contact with the heart, central circulatory or central nervous systems
On 23 July 2020, the Governor-General in Council made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis. The Australian Medical Device Regulations have been amended to delay implementation of some reclassification reforms from 25 August 2020 to 25 November 2021.” |
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On 9th May, Regulation soliciting comments on Classification Rules of In Vitro Diagnostic Reagents was issued. To support No. 739’s implementation, this IVD classification rule (draft) is under call for comments and is a good opportunity for IVD companies to provide inputs based on their global classification practice.
On 10th May, Regulation soliciting comments on Good Clinical Practice for Medical Devices was issued . The former is a regulation revision of Order No 25 regarding Good Clinical Practice of Medical devices. GCP is a very important regulation to guide clinical practices and this is a new opportunity to input and harmonize global common practices.
On 20th May, Regulation soliciting comments on List of Class II Medical Devices Exempted from Business notification was issued. According to No. 739 regulation on the supervision and administration of medical device article 41 item 2. NMPA listed attached class II MD which can be exempted from class II distinction notification. Class II MD list cover BGM, Electronic sphygmomanometer and etc. |
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On 18th April, Government of India issued Order F. No. 29/Misc/03/2021-Dec (28): Regulation of CT Scan Equipment, All Implantable Devices, MRI Equipment etc. as Drugs with effect from April 1st, 2021-Regarding. With this Order, Government of India has allowed medical device importers and manufacturers six months’ time for grant of import of manufacturing license for eight notified medical devices to implement smooth transition into the Medical Device Rules (MDR)-2017 (IDRAC 240630). Importers and manufacturers of the eight notified devices were supposed to be regulated with effect from April 1, 2021 as per MDR-2017 based on the Notification SO 775(E) of 08-Feb-2019 (IDRAC 290702). The eight medical devices include all implantable medical devices; CT scan equipment; MRI equipment; defibrillators; PET equipment; dialysis machine; x-ray machine; and bone marrow cell separator. As per this Order, it has been decided that in case an existing importer/manufacturer who is already importing/manufacturing any of these devices, has submitted application to Central Licencing Authority (CLA) or State Licencing Authority (SLA), as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from issue of this order or till the time, the CLA or SLA, as the case may be, takes a decision on the said application, whichever is earlier.
“At present various models of oxygen concentrators, having different capacities of continuous flow (1 to 10 Litres/Min) and widely varying concentration of oxygen, are being marketed. The Ministry has from time to time advised that oxygen concentrators with flow capacity of 5 litre per minute or more and delivering oxygen with concentration of 90% or more are suitable for management of COVID-19 patients at the COVID Care Centres, the Dedicated COVID Health Centres and in home settings. The World Health Organisation has also prescribed these norms for oxygen concentrators. Many people are not aware about these minimum parameters of Oxygen Concentrators and therefore may be using the concentrators that are not suitable for COVI D-19 case management. This advisory is issued to inform people about minimum standards of Oxygen Concentrators for COVID-19 case management, for use especially in home settings.
It is advised that Oxygen Concentrators having following specifications may be used in home setting: - Provides a continuous flow of concentrated oxygen (> 90%) from room air through one oxygen outlet
- Minimum Continuous flow of up to 5 Umin or more
- Contains oxygen monitor to verify concentration
- Digital or analogue meter that displays cumulative hours of device operation
It is advised that Oxygen Concentrators of less than 5 litres per minute capacity may not be sold under the misleading label of ""for home based COVID care.""” |
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The Drug Regulatory Authority of Pakistan issued Amendments in Medical Device Rules 2017. Drug Regulatory Authority of Pakistan has made certain amendments in Medical Device Rules 2017 after approval by Federal Governments that includes the extension in exemption period for all types of medical devices (A, B, C & D) from commencement of these rules and notified new Schedule E that contains Medical Devices which were previously declared as drugs under the drug act 1976.Futhermore the extension in exemption period is not valid for Schedule D and Schedule E medical devices. In recent development its compulsory for the Medical Device company to have establishment (Manufacturer or import) licence for import of any type of medical device in Pakistan. For the import of Medical Devices that have not been registered with authority the companies must submit certain documents to Pakistan Customs before its clearance from port. |
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On 22nd April, a draft FDA Circular: List of Class A Medical Devices was issued. This issuance aims to guide the manufacturers, importers, distributors and all other concerned stakeholders regarding the list of medical devices classified as Class A and to help the industry to determine the appropriate authorization specifically Certificate of Medical Device Notification (CMDN) to apply for their medical device products that fall under Class A classification. All medical device manufacturers, importers, exporters, and distributors shall apply for a CMDN prior to manufacture, distribution, importation, exportation, sale, offer for sale, and where applicable, promotion, advertising of Class A medical devices listed in Annex A.
If the product is not included in the list (class A to D), the company shall classify the device based on the intended use and on the classification rules of the ASEAN Medical Device Directive (AMDD) (IDRAC 236652). The CDRRHR shall verify the classification made by the applicant and shall reclassify the device if another classification is deemed to be more appropriate. The classification of medical devices listed in Annex A is subject to change if there will be additional indicated use, claim and duration of use of the product. New classification of the medical device shall follow the classification rules of the AMDD. Once finalized, Provisions of FDA Circular o. 2020-001-A (IDRAC 324734) that are inconsistent with this issuance are modified, withdrawn, repealed, and/or revoked accordingly.
The local industry association has submitted its response/suggestions to the FDA CDRRHR on May 25, 2021. A Draft Circular on the Adoption of Post Market Alert System (PMAS) Requirements, Annex 5 of the Asean Medical Device Directive (AMDD) was issued. FDA CDRRHR folly adopts the PMAS requirements of AMDD as a local regulatory guidance document. It will apply to all manufacturers, distributors, retailers, and entities dealing with medical devices. - CDHHRH shall issue specific guidelines on the PMAS requirements of medical devices
- All supplements, revisions to AMDD Annex 5 (PMAS) shall be adopted automatically
- The supplements, revisions to AMDD Annex 5 (PMAS) shall be made accessible in eth FDA website
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- Strengthening safety management for the use of raw materials with hazard concerns (phthalates, etc.) (Art. 5)
- Expansion of patient-specific medical devices (Art. 19) 3D printing manufacturing method for medical devices to be expanded to include ‘orthopaedics’ and ‘human tissue or functional replacement products’.
- Support for commercialization through expedited review of new technology medical devices (Art. 24)
- Deletion from the minor changes item ""Changes only for communication modules that do not change the internal circuit of the medical device among modules installed in the medical device"" (Attached Table 3, No. 41)
- Maintenance of the regulation, reflecting enacted and revised higher laws, etc.
This is a final version of a draft version MFDS Document for Public Comment: MFDS Announcement No. 2020-585: Administrative Advance Notice on Partial Amendment of Provision on License, Declaration and Review of Medical Devices (Draft), 24-Dec-2020 (IDRAC 323416). This document outdates MFDS Notification No. 2020-95: Provision on License, Declaration and Review of Medical Devices, 08-Oct-2020 (IDRAC 319221). |
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The Medical Devices Branch (MDB) has published a draft document, Consultation for Guidance on the Requirements for the Medical Device Unique Device Identification (UDI) System in Singapore. "The Medical Devices Branch (MDB) has published a draft document “Guidance on the Medical Device Unique Device Identification (UDI) System” for consultation. This document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database.
The Consultation period for this document is from 25 May 2021 to 30 June 2021. Please submit your feedback using the prescribed form to james.chan@varian.com for industry consolidation by 11 Jun 2021. |
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- Bi PAP
- CPAP
- High Flow Nasal Oxygen Therapy System
- Pulse Oximeters
- Finger Tip Pulse Oximeters
- Patient monitor - Basic
- Patient monitor – Advance
- Multipara patient monitor
- Ventilators -Transport
- Portable ultrasound scan machine
Initial process can be done via eNMRA and by submitting the manual dossier for registration. Companies who have already applied for registration or renewal can submit information to NMRA to expedite process."
On 21st May, National Medicines Regulatory Authority issued an Extension of certificates of registration, import licenses & manufacturing licenses. Due to prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority (NMRA) has decided to extend the validity of certificates of registration, manufacturing and import licenses pertaining to Medicines and Medical Devices for a period of one year. This extension can be considered for the certificates of registration and licences expired after 30th of June 2019 and would be expired up to 31st December 2021. This extension is applicable for re-registration and renewal applications only. Marketing authorization holders should apply for extension of each certificate of registration and licence before 31st August 2021. For medical devices marketing authorization holder should apply for re registration/ renewal through automation system before six months on the expiry of above extension. In addition, NMRA has also clarified on the procedure to be followed for applying extension. |
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- Drug-Eluting Stents, DES
- The first Class 3 device launched in Taiwan in the world
- Surgical mesh for transvaginal pelvic organ prolapse repair
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APACMed Regulatory Intelligence Editorial Committee |
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APACMed Regulatory Intelligence Working Group Cerline Tsai (Abbott), Crystal Nie (JNJ), Bu Fan (Roche), Seungmi Han (Roche), Leslie Kim (Stryker), Juliana William (Baxter), Wendy Lin (JNJ), Rhoel Laderas (Baxter), Shiho Tanaka (JNJ), Sahjogita Kathuria (Terumo), Deepali Deshmukh (Baxter), Cerline Tsai (Abbott), Wendy Lin (JnJ)
Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more. |
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