SOUTHEAST ASIA: Medical Devices regulatory updates in Philippines, Vietnamese and Malaysian markets

Below there are the latest news on the regulatory updates of Medical Devices in some South-East Asian markets of particular relevance and interest.

Medical Device regulatory updates in Philippine, Vietnamese and Malaysian markets
Medical Device regulatory updates in Philippine, Vietnamese and Malaysian markets

Philippines: FDA publishes new circular for the registration of Medical Devices

At the beginning of January 2021, the Philippines Food and Drug Administration (FDA) issued circular n° 2021-001 on the product standards to which Medical Devices must comply for notification or registration.

The circular was issued pursuant to the Administrative Decree n. 2018-002 to provide product standards defined as “medical device standards set”, to which local Manufacturers, Importers and/or Distributors must comply to obtain a certificate of Medical Device notification (CMDN) or a certificate of Medical Device registration (CMDR).

Moreover, at the end of January, the Philippines Food and Drug Administration (FDA) relaunched the verification portal for Medical Devices which provides complete lists of FDA-approved establishments and registered health products. Consumers can freely enter the portal to have access to information of safe and quality products.

For devices registered in the portal, they are publicly available information such as the name of the product, certificate of registration, name of the Manufacturer, country of origin, Importer and dates of validity of the registration.

Vietnam: published document on the preparation of Medical Device registrations

Recently, the Vietnam’s Ministry of Health (MoH) published the document n° 7395/BYT-TB-CT on the procedures for forwarding Medical Device Registrations. The purpose of this document is to help applicants to better understand and respect the regulation in order to be able to proceed as quickly as possible to the evaluation of applications for registration and, consequently, to facilitate the circulation of Medical Devices on the Vietnamese market.

Malaysia: published guidelines on masks for medical use

The Malaysian Medical Device Authority (MDA) has published a guideline on masks for medical use, specifying the requirements regulated by the Medical Device Act (Act 737).

MDA does not apply to non-medical masks and respirators, which are classified, instead, as Personal Protective Equipment (PPE) and they are not regulated by the MDA.

In the guide, MDA focuses on the performance, labelling and registration requirements and it lists two types of masks for medical use, which are regulated by the Medical Device Act and shall comply with the pre-registration requirements:

  1. procedural mask used to reduce the risk of spreading infections, when for example patients are in isolation (sterile environments, first aid, intensive therapy, etc…).
  2. surgical mask used inside the operating room or in other sterile areas to protect the patient’s environment from infection and who wears it from potentially contaminated liquid splashes.

Are you ready to market your device in the Philippines, Vietnam, Malaysia?

If you want more information or you are interested in registering your Medical Device in South East Asian Countries, contact us for a consultancy!

Sources:

FDA Philippines Circular 2021-001

Ministry of Health of Vietnam

Malesia Guidance Document medical face mask and respirator