CHINA (NMPA)

1. 12th China International Medical Device Regulatory Forum Held in Wuhan

The 12th China International Medical Device Regulatory Forum, organized by the China Center for Food and Drug International Exchange (CCFDIE), was held on September 24 in Wuhan, Hubei Province. Deputy Governor Zhang Wenbing delivered the opening remarks, and NMPA Deputy Commissioner Xu Jinghe attended and addressed participants.

HONG KONG (MDD)

2. Updated Guidelines for Listing of Medical Devices and IVDs

The Hong Kong Medical Device Division (MDD) has released revised versions of:

• Guide No. GN‑02 – Guidelines for the Listing of Class II/III/IV Medical Devices
• Guide No. GN‑06 – Guidelines for the Listing of In Vitro Diagnostic Medical Devices

All applications submitted on or after December 1, 2021, must use the updated forms and documents available under the “Application Form” and “Publication Documents” sections. Older versions have been removed.

INDIA (CDSCO)

3. Registration and Labeling Requirements for Medical Devices

The Ministry of Health & Family Welfare (MoHFW) issued notifications S.O. 648(E) and G.S.R. 102(E) on 11.02.2020, bringing all medical devices under the Drugs & Cosmetics Act and introducing registration requirements. 

• From 01.04.2020 to September 2021: voluntary registration period
• From October 2021 to September 2022: compulsory registration for Class A & B
• From October 2021 to September 2023: compulsory registration for Class C & D

Industry stakeholders reported challenges in achieving full compliance due to COVID‑19, and the matter is under review. Authorities are requested to consider these constraints to avoid supply disruptions.

PHILIPPINES (FDA)

4. New Validity Period for FDA‑CDRRHR Authorizations for Radiation Facilities

Beginning October 1, 2021: 

• Initial authorizations issued under the One‑Stop Shop (OSS) Licensing System will be valid for 3 years.
• Renewal authorizations will be valid for 5 years.

Authorizations will remain valid for corresponding DOH-issued documents provided no violations occur. Stakeholders are requested to disseminate this update.

AUSTRALIA (TGA)

5. Changes to Conformity Assessment Requirements

Effective 28 July 2021, certain devices—such as those containing medicines or materials of biological origin, and Class 4 IVDs—no longer require mandatory TGA conformity assessment certification. 

Sponsors may now use EU Notified Body certificates when applying for ARTG inclusion. However, the TGA may still audit applications to ensure compliance with Australian-specific requirements.

6. 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 meet Class III regulatory requirements, including evidence demonstrating safety and performance.

7. Reclassification of Spinal Implantable Devices

From 25 November 2021, certain spinal implantable devices will be reclassified. Sponsors must comply with new regulatory requirements, including: 

• More detailed QMS assessment
• Review of technical documentation
• Mandatory TGA audit and clinical evidence evaluation

8. Export Requirements for Therapeutic Goods

Therapeutic goods exported from Australia must comply with national legislation and any relevant state or territory laws. 

Medical devices, including IVDs and Other Therapeutic Goods (OTGs), must be included in the ARTG before export unless exempt or excluded. Guidance is available in the Australian Regulatory Guidelines for Medical Devices (ARGMD).