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:
- RDT-Ag swab kits will be tested by 2 different laboratories (amended to 1 with FR.02.01/5/0469/20);
- The standard operational test procedure includes 30 samples with CT ≤ 25, 30 samples with CT> 25, and 30 samples negative;
- Each laboratory will receive 100 RDT kits;
- Manufacturers should provide more than required to account for potential errors.
UPDATE: Estimated Cost to Import Test Samples
- Import license approval: IDR 500,000
- Import cost (Duties, VAT, etc.)
- Laboratory fees: IDR 67,500,000 (USD 4,700) + VAT (10%)
- 90 samples are required and lab fees are ~IDR 750.000/sample.
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).
|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
Manufacturers will also need to submit 2 copies of the following documents:
- Formal request for evaluation of the product addressed to the Director
- Product brochure
- Technical information
- 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
- Regulatory status: Global Product Certification (CE IVD, RUO) by National Regulatory Agencies of the country of origin
- Manufacturer’s Instructions for Use (IFU)
- Proof of Quality Management System: ISO/IEC
- Contact information (name of official contact person with e-mail address, landline, mobile number)
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