In August 2014, the Association of Southeast Asian Nations (ASEAN) — which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam — signed the ASEAN Medical Device Directive (AMDD). The AMDD creates a harmonized regulatory model for ASEAN countries, simplifying device registration for foreign medical device companies. The Philippines released draft device registration document requirements in late September 2014, based on the AMDD. The proposed requirements do not apply to in vitro diagnostic (IVD) devices.
The draft device registration requirements better align the Philippines with the ASEAN common submission dossier template (CSDT). The draft outlines the rule and risk based device classification system, with Class A (low risk — such as bandages) through Class D (high risk — such as implantable defibrillators). Class A devices require only medical device product notification. Classes B through D require product registration.
Depending on device classification, ASEAN CSDT documents that must be submitted include summaries of design verification and validation, manufacturer information and clinical evidence. In addition, the Philippines may also require documents such as a quality systems certificate of approval and a certificate of agreement between a distributor and the manufacturer. The list of devices that must be registered was most recently released in February 2014; the Philippines will expand coverage to other medical devices in phases.
Applications will be evaluated within 180 days, and companies will be given a chance to correct any documentation deficiencies. Once granted, the notification and registration certificates will each be valid for 5 years and must be renewed every 5 years.