ILHAM HIDAYATTULAH

“Indonesia’s Ministry of Health will only regulate Rapid Diagnostic Tests (RDTs).”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

Charmaine Roson - Philippines

“The Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia

Published on: May 4th, 2021

Manufacturers Should Expect an Extra 1-2 Months Added to the Review Process

Pursuant to recently released guidance in both countries, most COVID tests will now require in-country testing prior to receiving approval. At this time Indonesia’s Ministry of Health will only regulate Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.

Indonesia Requirements for Rapid COVID Test Kits

On April 22, 2021, the MoH released Announcement No:FR.02.01/5/0469/2021 declaring RDT COVID-19 test kits will require local testing at one of 7 currently MOH approved labs. Testing certificates must be obtained prior to submitting an application.

The details are regulated by HK.01.07/MENKES/477/2021 and include the following review process:

  1. RDT-Ag swab kits will be tested by 2 different laboratories (amended to 1 with FR.02.01/5/0469/20);
  2. The standard operational test procedure includes 30 samples with CT ≤ 25, 30 samples with CT> 25, and 30 samples negative;
  3. Each laboratory will receive 100 RDT kits;
    1. Manufacturers should provide more than required to account for potential errors.

UPDATE: Estimated Cost to Import Test Samples

  1. Import license approval: IDR 500,000
  2. Import cost (Duties, VAT, etc.)
  3. Laboratory fees: IDR 45,000,000 – 67,500,000 (USD 3,300 – 4,700) + VAT (10%)
    1. 90 samples are required and lab fees are ~IDR 500,000-750,000/sample.

Timeline for Importing Sample Kits

  1. Approval of Import Certificate: Approx. 2 weeks
  2. Actual Importation: Approx. 2 weeks
  3. Local Testing: 7-30 days

Philippines Requirements for COVID Test Kits

Per FDA Advisory 2021-0684, released on April 15, 2021, the Philippines FDA will now require COVID test kits acquire in country testing certification prior to approval. For complete guidance on the requirements, manufacturers can refer to Department of Health’s Guidelines On The Evaluation Of In Vitro Diagnostic Medical Devices And Other Related Laboratory Diagnostic Supplies for COVID-19, manufacturers will need to submit the following samples to the Research Institute for Tropical Medicine (RITM).

Product/Item Quantity
SARS-CoV-2/COVID-19 PCR Kit Good for 300 test
Nucleic Acid Extraction Kit Good for 150 isolations
SARS-CoV-2/COVID-19 Antibody/Antigen Kit Good for 100 test
Virus Transport Media 10 units
Oropharyngeal/Nasopharyngeal Swab 10 pieces

Manufacturers will also need to submit 2 copies of the following documents:

  1. Formal request for evaluation of the product addressed to the Director
  2. Product brochure
  3. Technical information
    1. NOTE: For PCR kits, include performance data, sensitivity and specificity, cross reactivity against human coronaviruses, and limit of detection data; previous evaluations by other laboratories; publications, if any
  4. Regulatory status: Global Product Certification (CE IVD, RUO) by National Regulatory Agencies of the country of origin
  5. Manufacturer’s Instructions for Use (IFU)
  6. Proof of Quality Management System: ISO/IEC
  7. Contact information (name of official contact person with e-mail address, landline, mobile number)

Come Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia and with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Blog Posts

Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices

Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.

Philippines Announces New PEMDL Essential Medical Device List

Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.

Russia and Euro-Asian Neighbors Expected to Transition to EAEU Regulations in 2022

With the release of Decree 142, the Russian government has provided a roadmap for their transition to the new EAEU medical device regulations beginning January 1, 2022. After this date, all applications submitted must adhere to the EAEU rules which can vary significantly from the current Russian requirements.