Home About Qualtech NEWS [ANALYSIS] The Overview of Requirement for High Risk Cosmetic Devices in Different Countries – August 2019
[ANALYSIS] The Overview of Requirement for High Risk Cosmetic Devices in Different Countries – August 2019

August 13, 2019

Asians – most especially the younger generations are one of the biggest fans of plastic surgery. Plastic surgery comes in different types, and consequently, a wide range of devices are being employed. Qualtech will be focusing more on the regulation procedures of most frequently used aesthetic devices, namely breast implants and dermal fillers, which are identified as the high-risk cosmetic device in most countries. We have selected some Asian countries and have analyzed the registration requirements for these types of devices. In order facilitate a more comprehensive discussion, separate articles shall be provided for ASEAN countries and China.  In this issue, we will focus on ASEAN regulations for aesthetic devices.

 

ASEAN Countries – Breast Implants and Dermal Fillers are Identified as High-Risk Device

As per ASEAN MDD, all medical aesthetic devices should fall within the scope of Medical Devices, hence, all pertinent provisions set in the guideline are also applicable for these types of devices. The extent of regulatory control depends on the device's level of potential health risk to the patients / end-users. For the purpose of easily stratifying the level of risks, the ABCD risk classification was implemented, with Class A indicating low risk and D as high risk. Consequently, high risk devices (Class C or D) will have more stringent rules compared to low risk devices (Class A or B). In the case of breast implants and dermal fillers which are placed in the body for a considerable period, these would fall under Class D (Rule 8) – and would therefore comply with extensive documentary requirements prior to its market approval. 

 

SINGAPORE – Comprehensive Supervision from Registration to Post-Market Surveillance

HSA has published a guidance that is solely dedicated for the modification of appearance or anatomy. The authorities have attached a list of high-risk devices that are intended for such purpose, and a flowchart (Figure 1) to assist applicants in determining if the device is regulated by the Agency or not. Once it is confirmed that the device shall be regulated as “Medical device”, product registration application shall ensue, following the documentary requirements, which, would depend on the device’s risk class. During registration, specific issues must be addressed (issues are listed in Table 1) as part of the device’s validation. After approval, marketing clearance will be issued by the HSA, which green lights subsequent importation and distribution of the product in Singapore. Dealers of medical devices are obliged to conduct post-market activities, including but not limited to reporting of adverse events, defects and recall to HSA and ensuring appropriate investigation, to ensure the continued safe use of the devices.

Analysis-Aug-2019-Fig1

 Figure 1. Determination if the device is regulated by the Agency or not

 

Table 1: Safety concerns to be addressed for Devices used for Aesthetic Purposes

Analysis-Aug-2019-Table1

  

MALAYSIA – Referred as Medical Device-Drug-Cosmetic Interphase

The rules may sound straightforward in Singapore; however, the opposite is true for Malaysia. In Malaysia, some aesthetic devices comprise a gray area – not easily classified as medical devices, drugs or cosmetics in accordance with Medical Device Act 737, Control of Drugs and Cosmetics Regulations 1984 and Sale of Drugs Act 1952. These types of devices are collectively referred to as Medical Device-Drug-Cosmetic Interphase (MDDCI) Products by Malaysian Authorities. When handling products under this type, the applicant should first verify from corresponding authorities whether the product will be regulated as medical device, drug, or cosmetic. (Please refer to Figure 2 for the guidance on the classification of medical device-drug-cosmetic interphase (MDDCI) products).  Basically, the decision as to how the product shall be regulated depends upon the its primary action. Interphase products such as soft tissue filler / dermal filler used for correcting contour deformities of the skin is a regulated medical device in Malaysia. 

Sometimes, medical devices may also consist medicinal substances which either exert primary therapeutic action (e.g., insulin pens), or assist in providing convenience to the patient (e.g., dermal fillers containing Lidocaine). Devices with medicinal substances where the primary action lies on the drug’s therapeutic activity is referred to as Drug-Medical Device Combination. Devices with medicinal substances where the primary action lies on the device’s function is a Medical Device-Drug Combination. Generally, Drug-Medical Device Products are regulated as Drug, hence, the Agency in charge of evaluating this product is the National Pharmaceutical Regulatory Agency (NPRA). Medical Device-Drug products on the other hand, are regulated as Medical Devices by the Malaysia Medical Device Authority (MDA). As in the case of dermal fillers containing local anesthetic agents such as lidocaine, these shall be regulated as medical devices because the achievement of the desired outcome (smoother or fuller appearance of the face) lies on the properties of the dermal filler rather than lidocaine.

 Analysis-Aug-2019-Fig2

Figure2. Guidance for the Classification of Medical Device-Drug Interphase (MDDCI) Products

 

INDONESIA – Following ASEAN MDD and Requesting the Distribution Report

Indonesia MoH has adopted ASEAN MDD, hence, the provisions under this guideline applies to all devices used in the modification of anatomy. Devices of this type also requires product registration to Indonesia MOH prior to placement on the market. Like in other countries, the extent of documentation is also commensurate according to the level of risk posed to patients. For high risk medical devices such as dermal fillers and breast implants, the registration requirements include, but are not limited to the following: 

  • Biocompatibility report; 
  • Clinical evidence report; 
  • Risk analysis report; 
  • Certificate of analysis for the raw material 

Medical device incorporating medicinal product as an ancillary role to achieve its intended purpose will be reviewed as medical devices by MOH. Examples of this type of device registered in MOH is Dermal filler incorporating analgesic, such as Lidocaine Hydrochloride, where the presence of Lidocaine is meant to reduce patient’s pain during treatment. Additional requirements for this type of medical device is required to see product safety and performance such as COA of the medicinal product and pharmacokinetics study of the medicinal product in the device. Once the devices are approved, the license holder will be required to submit a distribution report to ID MOH through e-report application. Pertinent information on adverse event related to the medical devices shall be reported to MOH via e-watch application for medical device.

  

PHILIPPINES -All Implantable Devices are Classified as Registrable

In the Philippines, there are no specific guidelines for medical aesthetic devices. PFDA assigns a unique classification to medical devices: Registrable and Non-registrable. Implantable devices, which includes dermal fillers are classified as Registrable and are hence strictly regulated – by virtue of its chemical composition, performance, risks, and use safety. Evaluators are highly concerned with the raw materials incorporated into the devices; hence, technical documentations are heavily focused on Raw Material Composition, Biocompatibility and Sterilization. Manufacturers should also pay attention to the storage conditions reflected onto the label – considering that the environmental conditions where the device is usually being stored might not be applicable to the Philippine setting where the room temperature and relative humidity is fairly high compared to countries in the temperate zones.

At the time of this writing, new regulations for medical devices are still about to be implemented. More stringent evaluation for high risk implantable devices such as breast implants and dermal fillers shall be expected.

  

CONCLUSION 

The surging demand for aesthetic devices has driven plastic surgery’s popularity across Asian populations of varying ages. Along with the dynamic trend in cosmetic innovations, the current demand is expected to increase even more, and the pressing need to effectively regulate medical aesthetic devices is foreseeable. In order to keep up with these progressive regulatory measures, it would be beneficial to consult with a competent regulatory consulting company such as Qualtech, due its vast experience in Asian Medical Device Registration which has already assisted a number of foreign manufacturers in complying with current national requirements.

 

References: 

1.       ASEAN Medical Device Directive 2015

2.       Summary of Medical Device-Drug-Cosmetic Interphase (MDDCI) Product Classification Decision

3.       Regulatory Guideline for *Devices For Modification of Appearance or Anatomy

4.       FDA Memorandum Circular 2014-005: Updated List of Medical Devices required to be registered prior to sale, distribution and use

5.       PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR 62 TAHUN 2017

6.       Pedoman Klasifikasi Izin Edar Alat Kesehatan

7.       Pedoman Bimbingan Teknis Perizinan Alat Kesehatan

 

 

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Home About Qualtech NEWS [ANALYSIS] The Overview of Requirement for High Risk Cosmetic Devices in Different Countries – August 2019