This Article gives a brief idea of South East Asian countries regulatory process:
The four South East Asian countries regulatory process discussed are Indonesia, South Korea, Philippines and Thailand.
NA-DFC is the regulatory body in Indonesia. The agency oversees the licensing and certification of pharmaceuticals and medical devices. Under the NA-DFC, the Deputy of Therapeutic Products and Narcotics, Psychotropic and Addictive Substance Control is responsible for pre-market evaluations of drugs and devices, including inspections of manufacturing sites to ensure Good Manufacturing Practice (GMP), and post-market surveillance activities once products have been licensed. These also include product sampling, laboratory testing, and inspections of manufacturing and distribution facilities.
To prepare for integrating with the ASEAN medical products regulatory system, Indonesia has introduced a new online medical device registration system and now requires the Common Submission Dossier Template (CSDT). Device distributors and manufacturers apply for distribution licenses, production licenses and product registration through the online portal — which is now integrated with the Indonesian customs database.
Class I: 30 working days
Class IIa and IIb: 60 working days
Class III: 90 working days
The validity of the registration certificate is minimum 2 years and maximum 5 years.
A registered office in South Korea or a South Korean License Holder to liaison with the MFDS must be appointed in South Korea.
Class I medical devices can be registered online directly on the MFDS electronic portal. They are exempted from technical review and KGMP certification.
In case your device falls under Class 1 (specially controlled), Class II, Class III or Class IV, a detailed technical dossier along with a sample device for testing must be submitted to the MFDS. In this process your Technical file or Safety and Effectiveness Review (SER) is reviewed either by the MDFC or a third party depending on the device class. After the technical review is complete the company has to apply for product approval.
- Class I Regular – 2 months
- Class II Regular – 6 months
- Class II with Safety Effectiveness Review – 15 months
- Class III Regular – 9 months
- Class III with Safety Effectiveness Review – 15 months
- Class IV Regular – 9 months
- Class IV with Safety Effectiveness Review – 15 months
KGMP certificate issued by MFDS and is valid for 3 years.
The principal medical device regulatory authority in the Philippines is the Bureau of Food and Drug Administration (BFAD), currently called as Food and Drug Administration under the Department of Health (DOH).
Medical equipment (other than radiation emitting equipment) does not need registration. All other medical devices must be registered in the Philippines. Currently the system is still at the nascent stage with the regulators setting up a formal system for the device registration.
The draft device registration requirements released in September 2014 better aligns the Philippines with ASEAN’s Common Submission Dossier Template (CSDT). The classification rules are based on the ASEAN Medical Device Directive (AMDD). The products are classified into class A (e.g. bandages) to class D (implantable defibrillators). Class B to D medical devices under this classification must apply for a Certificate of Medical Device Registration (CMDR).
The approval process takes 6-8 months.
The validity period for initial registration of a medical device is one year. Under BFAD Circular #05-1998, medical device renewal registrations are now valid for five years.
The classification system in Thailand is reverse of the US FDA with Class I devices having the highest risk. They are referred as “general devices” and Class II referred as “notification”. Additionally, import of used / refurbished equipment is prohibited in Thailand. Also it is compulsory to have the Certificate of Free Sale in the Country of origin.
Thai Class 1 devices need a license for sale in Thailand. They must show compliance with Thai Industrial Standards and in certain cases undergo testing by the Thai FDA. Products in this category include syringes, contact lens, surgical gloves and IVDs.
Thai Class 2 has to be registered with the Thai FDA. However, they do not need to go through the license process. Manufacturer must submit details on content, production process, labeling etc. Thai Class II includes silicone implants, blood alcohol measuring kits and rehabilitation devices.
Class III devices – products which are not covered by Class I and Class II are the general medical devices and have to just be validated by the Thai FDA. Following this an import license must be obtained. This covers about 90% of medical devices.
Class I: eight to ten months
Class II: six to eight months
Class III: two to six days
Class I and Class II medical devices: five years.
Class III devices: Dependent on validity of the Free Sale Certificate