Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

JAPAN (PMDA)

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387

The Ministry of Health, Labour and Welfare (MHLW) has released the latest Pharmaceuticals and Medical Devices Safety Information (PMDSI). This publication compiles safety data to support the safe use of pharmaceuticals and medical devices by healthcare professionals. It is available through both the PMDA Medical Product Information portal and the MHLW website.

The circular includes updates on:

• Yellow Letter / Blue Letter notifications 
• MHLW-issued safety information 
• Ongoing PMDA risk communication activities 
• Revisions to precautions 
• Alerts for proper use of medical devices (including those directed at patients) 
• Notifications related to safety actions 

Electronic Package Inserts 

MHLW has introduced electronic access to package inserts, with details available on system structure and methods for browsing. This information will continue to be updated.

INDIA (CDSCO)

Regulation of CT Scan Equipment, Implantable Devices, MRI Equipment, etc. as Drugs 

CDSCO has postponed import licensing requirements for eight medical device categories due to industry concerns surrounding COVID‑19 disruptions. To avoid supply chain impacts, manufacturers and importers with applications submitted by 18 April 2021 may continue activities until 30 June 2022 or until their application is decided—whichever is earlier. 

Applicants with incomplete submissions must provide all required documents by 31 March 2022. Authorities must decide on complete applications within three months. After 30 June 2022, import/manufacturing licenses are mandatory, and license numbers must appear on product labels.

VIETNAM (MOH)

Decree 98/2021 on Medical Equipment Management 

Vietnam’s Ministry of Health has released Decree 98/2021 ND‑CP, introducing major regulatory updates effective 1 January 2022. This decree replaces Decrees 36/2016, 169/2018, and 03/2020.

Key changes include:

• Import licenses remain valid through 31 December 2022. 
• Class C and D devices with valid import licenses may obtain Market Authorization (MA) licenses with a simplified 10‑day review. 
• Class B devices require an MA license beginning 1 January 2022. 
• Class C and D devices listed under Circular 30/2015 require MA licenses starting 1 January 2022. 
• Class C and D devices not listed may be imported with a Classification Certificate until 31 December 2022. 
• MA applications for Class B align with Class A requirements from 2022 onward. 
• Technical review is waived for Class C/D devices with reference country approval; review time targeted at 10 days. 
• MA licenses will no longer have an expiration date. 
• Registration holders may authorize multiple importers/distributors. 
• The Third-Party Classification mechanism has been removed; applicants must classify their own devices.

PAKISTAN (DRAP)

Amendments to the Medical Devices Rules, 2017 

DRAP has implemented amendments affecting manufacturing and quality management responsibilities. Updates include requirements that production and quality control staff must be full‑time employees with appropriate qualifications and experience as determined by the Medical Devices Board (MDB). Additionally, wording changes were introduced to rule 63 concerning documentation requirements.

AUSTRALIA (TGA)

Reclassification of Spinal Implantable Medical Devices 

Effective 25 November 2021, certain spinal implantable devices must comply with new classification rules. Requirements include detailed assessment of quality management systems, technical documentation, and clinical evidence, along with mandatory TGA audits of ARTG inclusion applications.

Reclassification of Medical Devices Introduced via Body Orifice or Applied to Skin 

Devices introduced through a body orifice or applied to the skin will undergo reclassification starting 25 November 2021. Sponsors must demonstrate safety and effectiveness appropriate to the higher classification.

Reclassification of Inhalation Devices for Medicines or Biologicals 

Medical devices used to administer medicines or biologicals via inhalation will be required to meet Class IIa or IIb requirements beginning 25 November 2021, including evidence demonstrating safety and performance.

Reclassification of Devices in Contact with the Heart, CCS, or CNS 

From 25 November 2021, devices intended for direct contact with the heart, central circulatory system, or central nervous system must fulfill Class III requirements, supported by appropriate safety and performance data.

System or Procedure Packs 

Updated guidance clarifies obligations for manufacturers and sponsors of system/procedure packs under the special conformity assessment procedure. It also outlines transitional arrangements for devices already included in the ARTG before 25 November 2021.

Declaration of Conformity Guidance 

System or procedure packs (excluding Class I/1 IVD): Guidance supports manufacturers completing Declarations of Conformity under clause 7.5.or system or procedure packs (other than a Class I or Class 1 IVD system or procedure pack).cedure packs (other than a Class I or Class 1 IVD system or procedure pack).

Class I medical devices and Class 1 IVDs: Guidance assists manufacturers in preparing required Declaration of Conformity documents. 

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