• 2020-03-18 10:32:08

The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.

• 2020-02-21 07:25:15

Having witnessed the changing and rapidly developing landscape of many Southeast Asian countries and their medical device markets, Qualtech has outlined the most convincing factors and trends on why you should definitely consider expanding your business to the ASEAN markets.

• 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

• 2020-02-13 05:54:53

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

• 2020-02-14 04:22:39

The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical device regulations and common technical documents which may help medical manufacturers easily penetrate the ASEAN Medical Device Market.

• 2020-02-14 07:47:54

The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.

• 2020-02-15 06:47:59

Medical Tourism in Southeast Asia: Indonesia's Opportunity Cost. (n.d.). Retrieved July 28, 2017

• 2020-02-15 08:19:45

More and more regulatory had been set up and released in ASEAN countries recently.

• 2020-02-15 07:57:54

Association of Southeast Asian Nations (ASEAN) is composed of 10 countries in Southeast Asia. It’s the market with good potential for someone who would like to build a stance in the market of medical devices.