November 2, 2021 Regulatory Updates

Medical Devices – Asia Regulatory Updates Roundup – Oct 2021


1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the Philippines

This Circular aims to:

  • Specify the establishments classified as retailers of medical devices;
  • Clarify the licensing of drug outlets which are also retailers of medical devices;
  • Provide specific requirements for and responsibilities of qualified persons of retailers of medical devices; and
  • Provide specific requirements for post-licensing inspection of retailers of medical devices.

All details about Guideline, Objective, Scope, Definitions are available in below web link

2.FDA Circular No.2021-0023 || Extension of Validity of Selected Special Certification for COVID-19 Test Kits under FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19”

This Circular aims to: On 12 March 2020, the Food and Drug Administration (FDA) issued FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19” to provide guidelines for the issuance of special certification for imported in-vitro diagnostic (IVD) test kits used for diagnosis and screening of COVID-19.

Subsequently, FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for Screening of SARS-CoV-2 Infection” was issued on 23 March 2021 to set the minimum performance requirements for COVID-19 test kits and to provide specific guidelines on the re-evaluation of product performance of COVID-19 test kits with Special Certification by the FDA. In addition, FDA Memorandum No. 2021-009 also provides for the validity of all issued Special Certification under FDA Memorandum No. 2020-006.

Section III (C) of FDA Memorandum No. 2021-009 stipulates that “All issued Special Certification under FDA Memorandum No. 2020-006 shall be valid for a period of six (6) months from date of this guideline unless otherwise revoked earlier”. Thus, as per stated provision, all issued Special Certification under FDA Memorandum No. 2020-006 shall expire on 23 September 2021.
In the interest of service and to ensure the availability of COVID-19 testkits during the continuing pandemic, this Circular is hereby issued.


3. Forum held to boost medical device standardization

Sponsored by the National Medical Products Administration (NMPA), the China Medical Device Standards Forum was held in Beijing on Oct 14, the 52nd World Standards Day. With the theme “Better standards make for higher-quality medical devices”, the forum aimed to further promote the concept of medical device standardization and give better play to the supporting role of standards in facilitating medical device regulation and the high-quality development of related industries.

In recent years, the NMPA has made continuous efforts to deepen the reform and innovation of medical device standardization, improve the legal system for medical device standards and advance plans to upgrade standards for medical devices.

Currently there are 1,835 medical device standards in China, which cover almost all the professional and technical fields.

At the forum, the China Association for Medical Devices Industry announced the first group of 10 model enterprises for the implementation of medical device standards.

On the same day, the 7th International Electro technical Commission (IEC) International Medical Device Standards Forum with the theme “medical device standards in the era of innovation, science and technology” was held in Shenzhen, South China’s Guangdong province.


4.MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021)

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 ( and on the MHLW website.

Thailand (FDA)

5.Thailand FDA – HSA Singapore Regulatory Reliance

Thailand FDA – HSA Singapore Regulatory Reliance is an expedited medical device registration program between regulatory agency that make an offer to the manufacturer or importer to shorten the duration of registration. Since the Medical Device Control Division, Thailand FDA has been recognized the Health Science Authority agency, Singapore as a reference agency, in this program, the Thai FDA will assess the performance and safety of the medical device in cooperate with the Health Science Authority agency, Singapore’s evaluation report.

India (CDSCO)

6.Notice regarding Review of regulatory regime for drug approval

F. No. 12-01/21-DC (Pt-306 – XXXVI- MDTL) Government of India:

In order to enhance the testing capacity of medical devices in the country identification registration & empanelment of government private testing laboratories for medical device testing is under consideration as per medical devices Rules. 2017.

In this regards, Laboratories which have capacity for testing of medical devices & are NABL accredited & interested in above process are requested to intimate the same to CDSCO at & along with details of categories of such medical devices and capacities & capabilities of testing to CDSCO for initiating further examination and communication in this regard.


7.Submissions received: Proposed refinements to the requirements for medical device patient information materials

The TGA thanks respondents who provided a submission to the public consultation: Proposed refinements to the requirements for medical device patient information materials – Australian Government Department of Health.

This consultation related to the implementation of the requirement for sponsors of implantable medical devices, to provide patient information leaflets (PIL) and patient implant cards (PIC) about their medical device. The requirements commenced in late 2018, with a gradual implementation over three years.

8.Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia

The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing the Government’s reforms. We have released this Discussion Paper seeking feedback on potential changes to mandatory reporting of medical device adverse events – as part of the reform program.

9.Information for medical practitioners on pending up-classification of surgical mesh devices

This guidance is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1 December 2021.

Supply disruption could be experienced due to some sponsors not able to demonstrate that they meet Australian regulatory requirements for safety, quality, and performance for these types of devices.

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