Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

December 15, 2021 | Medical Device

Japan(PMDA)

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

At the This Pharmaceuticals and Medical Devices Safety Information (PMDSI) publication is issued reflective of safety information collected by the Ministry of Health, Labour and Welfare (MHLW). It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. The PMDSI is available on the Pharmaceuticals and Medical Devices Agency (PMDA) Medical Product Information web page (https://www.pmda.go.jp/english/index.html) and on the MHLW website.

Provision of Information regarding Post -Marketing Safety updated.

This Circular aims to:

The Yellow Letter / Blue Letter
Safety Information announced by MHLW
PMDA Risk Communications (Medical devices Risk Information of ongoing evaluation)
Revisions of PRECAUTIONS
MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)
Notification on self-check
PMDA Alert for Proper Use of Medical Devices
PMDA Alert for Proper Use of Medical Devices (for patients)
Notifications Related to Safety Measures

Information regarding Newly Introduced Electronic Package Inserts.

Basically, package inserts should be browsed in an electronic way.
This web link introduces how the electronic package inserts are browsed, and its detailed systems and specifications.
The information on this page is current as of 2021 and will be updated in the future.

India (CDSCO)

Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st, 2021- Regarding.CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.

Whereas order of even number dated 18.04.2021 on the subject cited matter was issued by CDSCO (copy enclosed).
Whereas the stakeholders have now represented their concerns that due to Covid-19disruption there is unpreparedness in complying with regulatory requirements within the prescribed timelines, which may lead to disruption of supply chain & access to patients.
Now, therefore, in order to ensure smooth transition of manufacturers/importers, continuity of supply chain and access to the patients, with the approval of MoHFW, it has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license in respect of the said device(s) under provisions of MDR, 2017 by 18.04.2021, the said application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier
Further, the applicant, in case has submitted an incomplete application (submitted by or before 18.04.2021), is required to ensure submission of all the necessary documents to the concerned Authority, by 31.03.2022
Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose of these applications within three months from the date of receipt of complete application
.Further, the importer/manufacturer of above said medical devices has to obtain
Import/manufacturing license for the above said devices by or before 30th June, 2022. The importer/Manufacturer shall necessarily be required to print the import/manufacturing license number on the label with effect from 1st of July 2022

Vietnam (MOH)

Decree About medical equipment management

Republic Diary No. 98/2021

The Ministry of Health (MOH) officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device regulations in Vietnam.

Decree 98/2021 ND-CP will go into effect on January 1, 2022 and will replace previously issued
Decree 36/2016, Decree 169/2018, and Decree 03/2020/ND-CP.

All aspect of the new Decree streamline compliance requirements compared to earlier plans and should be positively received by industry.

Important Highlights of Decree 98/2021:

All existing, or newly issued Import Licenses will remain valid until Dec 31, 2022. (No new Import License applications will be accepted after Dec 31, 2021.) Class C and D devices with Import Licenses will avoid a technical review and be processed in 10 days when applying for a Market Authorization (MA) License.
All Class B devices (not covered by a valid Import License) must have a MA License to be imported from Jan 1, 2022. (Note: Class A devices have required an MA License since Jan 1, 2020.)
Class C and D devices (not covered by a valid Import License) that are listed in Circular 30/2015 (link to list here), must have a MA License to be imported from Jan 1, 2022.
Class C and D devices that are not listed in Circular 30/2015, can be imported with a Classification Certificate until Dec 31, 2022 after which a MA License will be required.
Class B MA License application will have the same requirements as for Class A devices starting Jan 1, 2022.
For Class C and D devices with reference country approval, the technical review is waived. MOH application target proceeding time will be 10 days with reference country approval. (Note: China and Korea have been added to the US, Europe, Japan, Australia and Canada as reference countries.)
MA Licenses will be issued without an expiration date (instead of the previous 5-year validity period).
Registration Holders do not need to be the initial importer; and multiple importers/distributors can be authorized under the same MA license.
Third Party Classification process has been removed and is now the responsibility of the applicant/registration holder

Pakistan (DRA)

Amendments in the Medical Devices Rules, 2017

Regulatory Authority of Pakistan Act,2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with approval of the Federal Government, is pleased to direct that the following amendments shall be made in the Medical Devices Rules, 2017, namely:-
In the aforesaid Rules,-
(a) in rule 6, in sub-rule (l).-
(i) for clause (c), the following shall be substituted, namely;-
“(c) the manufacturing shall be conducted under the active supervision of competent technical staff, who shall be in-charge of production, a whole time employee of the manufacturer and having relevant qualification and experience as deemed appropriate by the MDB;”; and
(ii) for clause (e), the following shall be substituted, namely:-
“(e) the in-charge of quality control shall be a whole-time employee of the manufacturer and shall possess relevant qualification and experience as deemed appropriate by the MDB;”; and
(b) in rule 63, in sub-rule (3), expression after the words “omit any”, the words “Form or” shall be inserted.

AUSTRALIA (TGA)

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.

Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, some medical devices that are substances for introduction into the body 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.

Reclassification of medical devices that administer medicines or biologicals by inhalation

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).

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.

System or procedure packs

Guidance for sponsors, manufacturers and charities

From 25 November 2021, new regulatory requirements apply to medical devices that meet the definition of ‘system or procedure packs’ and are supplied using the special conformity assessment procedure regulatory pathway.

This guidance aims to assist sponsors and manufacturers of these medical devices, by explaining their obligations under the new regulations and transitional arrangements for any of these medical devices included in the ARTG before 25 November 2021.

Guidance for Declaration of Conformity

Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs
This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.

Guidance for manufacturer’s declaration of conformity for system or procedure packs

Other than Class I or Class 1 IVD system or procedure packs
This document is to assist manufacturers of system or procedure packs in completing the declaration of conformity made under clause 7.5 for system or procedure packs (other than a Class I or Class 1 IVD system or procedure pack).