May 11, 2018
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.
The aim of reducing technical barriers frequently encountered in the registration of medical devices across ASEAN countries aligns itself with the provisions given in the ASEAN Trade in Goods Agreement and Declaration of ASEAN Concord II, which ultimately results to the establishment of ASEAN as a single market and production base.
The AMDD includes Articles presenting the guidelines on the different aspects of the Medical Device Registration Process, more notably, the Classification of Medical Devices (Article 4), including its supporting Annexes providing the Risk Classification Rules for Medical Devices other than IVD Devices (Annex 2) and Risk Classification Rules for IVD Devices (Annex 3), Technical Documents for Medical Devices (Article 8), and Post-Marketing Alert System (Article 12).
Article 4: Classification of Medical Devices
Medical Devices shall be classified according to their risk classification levels, namely:
§ Class A: Low Risk
§ Class B: Low to Moderate Risk
§ Class C: Moderate to High Risk
§ Class D: High Risk
Special rules on the classification may, however, apply in specific cases (or situations) such as the following:
§ Medical devices which may be assigned into 2 or more classes, where the highest risk class shall be applied
§ Medical devices to be used in combination with another medical device, where medical devices shall be classified separately
§ Medical devices having 2 or more intended uses, where, the medical device shall be classified according to its most critical intended use
§ In the event of disputes between member state and any person involved in the classification for medical device, where, the risk classification lies upon the Regulatory Authority of the Member state where the medical device is being registered.
§ Member State that does not conform to the classification rules set out by the Committee in the Annexes 2 and 3, where, it is mandated that the former shall notify the latter regarding any deviation/s, along with the reasons thereof.
Article 8: Technical Documents for Medical Devices
This section mandates all member states to obtain the following technical documents from applicants during the Medical Device Registration Application
(a) Submission Dossier that follows the Common Submission Dossier (CSDT) format given in Annex 4;
(b) Post Marketing Alerts System requirements (PMAS) in accordance with the template given in Annex 5; and
(c) Harmonized set of elements for a Product Owner’s or Physical Manufacturer’s Declaration of Conformity (DoC), following the content and format given in Annex 6.
Article 12: Post-Marketing Alert System
This requires all Member states to take effective measures in monitoring, recording and evaluating all issues concerning a device's safety and efficacy.
Expectation vs. Reality
The provisions given in the AMDD has been signed, and agreed upon by Economic Ministers from the ten (10) member states, namely: Governments of Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Republic of the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Viet Nam. With its implementation, the AMDD may serve to help most Medical Device Industries enter the ever evolving ASEAN market by reducing costs associated with long market access, advertising, and most importantly, by enhancing regulatory efficiency.
Despite the fact that Singapore and Malaysia take lead on the initial implementation of the regulations set forth in the AMDD, difficulties in the systematic execution are still apparent in most countries – hence, more feasible approaches are being targeted for faster and smoother enactment of the said Agreement. (See Table 1 for the regulation progress of all ASEAN countries)
It’s noteworthy to keep in mind that although most countries are already putting the Risk Classes A, B, C and D into effect (in accordance with the AMDD), the different devices that fall into each class still varies from country to country. Taking contact lenses as an example, it’s eligibility to be included in Class B in Malaysia and Singapore does not preclude its eligibility as a Class B medical device in Indonesia (where it falls under Class C).
Table 1. Progress of ASEAN Medical Device Directive (AMDD) Regulation Integration among the ten (10) Member States
While the AMDD intends to standardize most of the documentary requirements for a shorter evaluation time, local guidelines are still in place to be followed. This results to some differences in the documentary requirements across different countries, and hence, to the best of our knowledge, the approval of a certain medical device to one Member State does not preclude its approval to other Member states.
Nevertheless, it is highly imperative that all ASEAN countries make an effort to integrate AMDD into their local regulations, by developing feasible guidelines, phase-by-phase implementation, provision of acceptable grace period for industries, and close monitoring of the implementation process. Transition phase may be challenging for most, but its successful implementation may subsequently drive the growth of the Medical Device Industry across Asia.
To bring this article to close, all Medical Device Industries are expected to keep themselves abreast with the expected regulation changes to be implemented in each of the ASEAN countries, as they gear themselves up in aligning their internal regulatory compliance procedures with the guidelines provided in the AMDD.
The ASEAN Secretariat Jakarta. 2015. ASEAN MEDICAL DEVICE DIRECTIVE. Accessed on 2nd May 2018
World Health Organization. 2016. Medical devices regulatory systems at country level. Accessed on 2nd May 2018