We are delighted to bring you the April 2021 issue of the Asia Pacific MedTech Regulatory

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Dear APACMed Members,  
 
We hope you are doing well during these challenging times. 
 
We are delighted to bring you the April 2021 issue of the Asia Pacific MedTech Regulatory Intelligence Watch. 
 
The objective of the Watch, brought to you by our Regulatory Intelligence Working Group, in partnership with Cortellis, is to provide APACMed members with timely regulatory updates and actionable insights for markets across Asia Pacific. 
 
Sincere thanks to the Editorial Committee and Working Group for their contributions to this newsletter. Please feel free to reach out to us directly for any further information or questions.              
 
Best wishes, 
APACMed Secretariat
Regulatory Updates from Asia Pacific Markets
Australia

On 12th March, TGA issued Notice :Regulation of Thermometers and Other Temperature Measuring Medical Devices and Products for COVID-19. The Australian Therapeutic Goods Administration has issued a notice for Classification of thermometers and any other temperature measuring medical devices, including thermal imaging systems.  The classification of thermometer will be dependent on the design, duration and intended purpose of the device. Clinical thermometers that are not battery-powered, such as glass and mercury, will be regulated as Class I (measuring) devices. All battery-powered digital thermometers, such as infrared or electronic thermometers, that work by converting energy from electric/infrared light/radiation to thermal/heat energy will be regulated as Class IIa devices. Body temperature measuring devices, such as those used for screening people in public places that include an infrared radiation measurement technique will be regulated as Class IIa devices. Manufacturers and Australian sponsors must ensure that the appropriate classification applied and able to provide appropriate documentations to demonstrate compliance.
 
China

On 26th March, NMPA issued three Notifications on Soliciting Public Comment on Provision for the Supervision of Distribution of Medical Devices (Revision) (Draft), Soliciting Public Comment on Provision for the Registration of Medical Devices (Revised Version) (Draft) and Soliciting Public Comment on Provision for the Registration of In Vitro Diagnostic Reagents (Revised Version) (Draft). NMPA is collecting industry comments regarding sub-level regulations. This is a very important and great opportunity for each member to review and provide their feedback either through local associations or directly share back to NMPA based on their company product situation and global common practices. Sub-regulations including MD and IVD registration regulations’ full implementation based on China’s new MDR and further clarify requirements such as MAH, self-testing report requirements, clinical evaluation report exemption.

On 6th April, NMPA issued a Notification on Issuance on Checkpoints for Adverse Event Surveillance on Medical Devices Registrants and Filers. This document provides the new regulations on quality management system inspection, special inspection of adverse event monitoring and daily supervision and inspection of medical device.
 
India

CDSCO issued Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021. The CDSCO has previously notified CT Scan, all implantable devices, MRI equipment, PET, Dialysis machine, X Ray machine, defibrillator, Bone marrow cell separator which were to be regulated effective 01 April 2021. In light of the representations received from the industry to plan for procedural work, testing of products etc. CDSCO vide order dated 18 April 2021, has stated that if an importer/manufacturer has already submitted application under MDR 2017 to CDSCO, then the said importer/manufacturer can continue to import/manufacture the products till 6 months for issuance of the order (i.e. up to 17 Oct 2021 or till the CDSCO has passed its decision on review of application, whichever is earlier).
 
On 31st March, CDSC issued a Notice on Provision of a single platform for filing of regulatory application 15th April onwards for both center and states. As per this notice, there will be a single platform for filing of regulatory application from 15th April onwards for both center and states for regulatory submission and issuance of licenses for drugs.
 
Indonesia

On 12th April, Technical instructions for investigation of adverse events were released. The objective is to guide experts/investigator teams on the assessment of medical device adverse events and provide input to MoH. 
 
Japan


The Japan authority (MHLW) published these two RWE related guidance, such as, patient registry data usage for pre-market approval. First on is ‘Basic Concept of the usage’ and second one is related to data reliability of the registry data. The guidance indicated possible cases of registry data usage, included one of the evaluation data for product registration with some conditions, the points to consider for data reliability, such as informed consents. The guidance strongly recommends the use of PMDA consultation before using it.
 
Pakistan

The Government issued a Ban on import of conventional syringes. According to the S.R.O. 483 (1)/2021 of Federal Government Conventional Syringes (2ml, 2.5ml, 3ml & 5ml) are banned from import. The Federal Government has imposed ban on import of conventional syringes with immediate effect.
 
Philippines

On 23rd March, FDA issued Memorandum No. 2021-009: Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection. This memorandum states that -"All existing COVID Special Certifications are valid up to 23 Sept 2021 only. All applications for COVID Special Certifications from 24 March 2021 must be validated by the national reference lab (RITM) prior to approval, and will be valid for 1 year. Failure to meet the minimum criteria above is a ground for disapproval of the COVID Special Certification. In case of failed performance results, the marketing authorization holder may seek re-evaluation with RITM within 20 working days from the receipt of Notice from FDA. The result of re-evaluation shall be final; this will determine whether the product can be allowed for sale or subject to recall/ revocation of Special Certification. For products with previously approved Special Cert, failure to meet the performance requirements are subject to immediate recall. Products should not be in the market 7 days after the issuance of the FDA advisory."
 
South Korea

On 12th March, MFDS released MFDS Announcement No. 2021-112: Administrative Advance Notice on Establishment of Provision on Renewal of Medical Device. This announcement states -"The draft of MFDS sub-regulation to guide about submission requirements for medical device license renewal released. The draft concerns:
  1. Matters concerning the standards for renewal of manufacturing license, etc. (Art. 3)
  2. Matters concerning the procedures for application for renewal and how to prepare an application (Art. 4 and 5)
  3. Matters concerning the types, scope of exemption and requirements for renewal submission data (Arti.6 to 8)
  4. Matters concerning the supplementation of data, renewal processing, and designation of shelf life (Art. 9-12)

In terms of submission data, it's required to submit:
  1. license copy
  2. safety data to prove safety and effectiveness which is confirming that the approval is compliant with the state-of-the-art standard. Testing report and evaluation report for the safety on top of the testing, can be submitted, however evaluation report need to submit and get confirmation by 3rd party NB if it's acceptable
  3. Importing records
  4. Post market surveillance safety information
 
On 1st April, MFDS released Korea Good Manufacturing Practice (KGMP) for Medical Devices. This is a new revised version of Korea Good Manufacturing Practice (KGMP) for medical devices. This revision concerns strengthening operation of GMP system by specifying training requirements to maintain qualifications for quality control audit institutions (Appendix 8-2) and for document-based review to require additional submission of data such as “a copy of the quality management system conformity certificate issued by the government of the producing country” (Article 7-1- 2 and 7-6-2, Form 1).

This document contains the following attachments: Attached Table 1. Definitions Attached Table 2. Inspection Standards for Medical Device Conformity Certification, etc. Attached Table 3. Medical Device GMP Products Groups Attached Table 4. Compliance Certification Subjects and Methods Attached Table 5. Issuance and Management of Certification of Compliance Attached Table 6. Compliance Certification Inspection Mark Attached Table 7. Evaluation Criteria for Medical Device Quality Control Review Agency Attached Table 8. Standards for Management and Operation of Medical Device Quality Control Audit Institutions Attached Table 9. Criteria for Designation of Quality Manager Training Agency This document is a final version of a draft available in MFDS Notification No. 2020-476: Administrative Advance Notice on Partial Amendment of Korea Good Manufacturing Practice (KGMP) on Medical Devices (Draft), 04-Nov-2020 (IDRAC 320513). This document will replace MFDS Notification No. 2020-103: Korea Good Manufacturing Practice (KGMP) for Medical Devices, 26-Oct-2020 (IDRAC 320094) upon its implementation on 01-Jun-2021. 
  
On 7th April, MFDS released Notification No. 2021-31: Korean Good Manufacturing Practice (KGMP) for In Vitro Diagnostic Devices. This revision is to reflect that in the case of a GMP audit that only reviews documents, the documents to be submitted are additionally defined, and in accordance with the full application of the GMP audit standards ('20.7.1.) reflecting the latest international medical device quality management standards (ISO 13485:2016).
 
Taiwan

On 18th March, MOHW issued Announcement No.1091107544: List of Medical Devices to Establish a Medical Device Good Distribution System. The Announcement conveyed - "Impact Analysis: The medical device dealers who distributes 45 classification products shall establish GDP system, 44 classifications are Class 3 products (ex: Cardiovascular stent, Silicone inflatable breast prosthesis, Silicone gel-filled breast prosthesis, Absorbable haemostatic agent and dressing, etc.), 1 classification is Class 2 product (i.e. Single/multiple component metallic bone fixation appliance and accessories). The effective date is 1-May-2023.
Suggestion: The medical device dealers who distribute these 45 classification products shall start to establish GDP system and obtain TFDA's distribution license to avoid business impacts."
 
On 25th March, MOHW released Announcement No.1101101453: Soliciting Public Comment on List of Medical Devices Exempted from Obtaining Medical Device Manufacturing Licenses (Draft). Per this new announcement, except for the 90 items listed, for the rest Class I devices which are no measurement function and non-sterile are all considered as affected as getting GMP/QSD in a timely manner for these class I is required now.
 
"Impact Analysis: This regulation is to link the retailing device categories to the classification rules based on the new medical device act. The retailing scope does not change.
Suggestions: No new changes are introduced except referencing of the new medical device."
 
"Impact Analysis: This is a new requirement for Taiwan MD industry. It is required for device firm to register at least one representative technicians along with its medical device firm permit. For device firm performing servicing activities, it is required to register at least one representative servicing engineer. The registered personnel should maintain fixed training hours as required annually to stay qualified as medical device technicians and servicing technicians.
Suggestions: Registration of technician and/or servicing engineers is required starting May 1, 2021. Grace period is 3 years. "
 
On 6th April, MOHW issued  Announcement No.1101602479: Requirements for Indicating the Unique Device Identifier on Medical Device Labels. The Announcement states - "Impact Analysis: UDI is the new requirement in Taiwan MD industry. There are three implementation phase. Phase 1: 1-June-2021 for Class 3 implanted MD. Phase 2: 1-June-2022 for Class Non-Implanted MD. Phase 3 :1-June-2023 for Class 2 MD. 24 attributes (including local license no., product description, size and storage condition, etc.) are the essential information required to uploaded to Taiwan UDI database. Some devices are Exempt from UDI, including the customized device, medical device exclusively for export and the non-implant single-use accessory packaged in the MD kit and IVD.
Suggestion: The MD license owners who distribute the Class 3 implants shall prepare the UDI sheet to upload by 1-June-2021. "
 
Impact Analysis: This is newly created to separate medical device clinical trial requirements from the previous Good Clinical Practice that focus more on pharmaceuticals. There's no new requirement introduced but mostly follow the current international Good Clinical Practice based on ethical and patient protection concepts.
 
On 13th April, MOHW issued Order No.1101101273: Regulations of Medical Device Good Distribution Practice (GDP). The Order states -"Impact Analysis: This is new regulation for Taiwan Medical Device industry to regulate the requirements of medical device distribution. TFDA also published ""List of Medical Devices to Establish a Medical Device Good Distribution System"" and identufied that the medical device dealers who distribute 45 classification products shall establish GDP system, the wholesale, import, or export may only begin after obtaining a distribution license.
Suggestion: The medical device dealers who distribute the specific 45 classification products shall start to establish GDP system and obtain TFDA's distribution license by 1-May-2023 to avoid business impacts."
 
Vietnam

Vietnam Decree-Amending Decree 169 states that "Vietnam DOH issue the decree related to Medical Equipment Management to amend the Decree 169. The main point on this decree is on the article 83 which extending the transition period from Dec 2021 to 31st Dec 2022.

The issuance of Import License and issuance registration licence of domestic Medical Device or IVD will be implemented as below:
a.    Import licenses for Class B, C and D medical devices and import licenses for in vitro diagnostic biological products issued in 2018, 2019, 2020, 2021, shall be valid until the end of December 31, 2022 and the customs authority shall not control the quantity of imported products except for the cases prescribed in Clause 1 Article 56 and Point d of this Clause.

Organizations and individuals trading in medical devices shall be responsible for ensuring that the documents specified in Point i Clause 2 Article 81 hereof are valid during the validity period of the import license. In case of failing to maintain the validity of the above documents, organizations or individuals trading in medical devices shall be responsible for notifying the Ministry of Health thereof to revoke import licenses granted in accordance with regulations.

b.    Class A medical devices with Acknowledgement of Receipt for Declaration of applied standards dossiers issued by the Department of Health are permitted to be imported on demand, unrestricted quantity, without risk classification table as well as any written document from Ministry of Health to confirm that those are medical devices when implementing customs clearance;

Medical devices that are not listed as requiring import license and are already classified into Class B, C, D medical devices by organizations that are eligible to classify medical devices as announced by the Ministry of Health on its online portal, are permitted to be imported on demand with unrestricted quantity until the end of December 31st, 2022, without any written document from Ministry of Health to confirm that those are medical devices when implementing customs clearance;".
 
APACMed Regulatory Intelligence Editorial Committee 
Miang Tanakasemsub (Cardinal Health), James Chan (Varian Medical), Jane Lin (JNJ), Shivkumar Hurdale (Stryker), Muhammad Sohail (Fresinus Medical Care), Anirudh Sen (APACMed), Tanvi Sapra (APACMed)

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), Yenny Anggoro (Stryker), Sahjogita Kathuria (Terumo)

Data powered by Cortellis Regulatory Intelligence, a suite of intelligence offerings from Clarivate. Please click here to find out more.

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