DRAP launches probe into registration of Taiwan-made medical devices, raises one-China policy concerns

The Drug Regulatory Authority of Pakistan (DRAP) has launched an investigation into the registration of medical devices manufactured

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has launched an investigation into the registration of medical devices manufactured in Taiwan, with officials raising serious questions over whether the approvals were granted in violation of Pakistan’s stated One-China Policy and applicable regulatory requirements.

According to sources, DRAP will initially conduct a departmental inquiry to determine the companies involved in the registration process as well as the role of the concerned authority officials. Once the internal investigation is completed, the matter may be referred to the Federal Investigation Agency (FIA) for further proceedings if evidence of violations, misuse of authority or other irregularities is established.

Questions Over Registration and Documentation

Officials have raised questions about the legal and documentary basis on which the Taiwan-made medical devices were registered in Pakistan, particularly because Pakistan does not maintain an embassy in Taiwan.

Investigators are examining what documents were submitted by importers at seaports and airports, which country’s Free Sale Certificate (FSC) was presented to DRAP, and how the authenticity of those documents was verified in the absence of Pakistani diplomatic representation in Taiwan.

Under the applicable regulatory framework, an FSC is required to be attested by the Pakistani Embassy in the country where the medical device is manufactured. The certificate is also expected to confirm that the product is manufactured in that country and is freely available for sale there.

Officials are also examining the application of Rule 67, under which an additional FSC from a third country may be required where a product manufactured in one country is exported to another jurisdiction before being supplied to Pakistan.

Complete Records Sought

As part of the investigation, DRAP has sought comprehensive records relating to the registration and importation of the Taiwan-made devices.

The information being examined includes the country of origin declared at the time of import, names and addresses of manufacturers, details of FSC issuing authorities, dates of certificate issuance, procedures used for document verification and evidence of Pakistani Embassy attestation.

Investigators are also seeking clarification regarding the documents accepted in place of the requirements prescribed under Form 7A during the registration process.

Another key aspect of the inquiry is whether medical devices manufactured in Taiwan were registered by referring to regulatory approvals or certifications associated with other jurisdictions, including the United States, United Kingdom, European Union, FDA or CE certification systems.

Previous Foreign Office Position

The inquiry has also taken into account communications from the Ministry of Foreign Affairs, which, according to officials, had informed relevant institutions in 2007 and 2021 that registration of medical devices originating from Taiwan was not permissible under Pakistan’s One-China Policy.

Officials are now examining decisions taken after the 31st DRAP meeting in 2020, when the Medical Device Board had reportedly considered the Taiwan-related policy issue.

The investigators want to determine how subsequent registrations were approved, which officials authorized them, and whether any amendment to the law was subsequently approved by Parliament or whether permission was obtained from the Ministry of Health to allow such registrations.

Possible FIA Referral

DRAP officials have warned that failure to produce authentic documentation or evidence of a lawful exemption could turn the matter from a departmental issue into a case involving possible misuse of authority, violation of regulatory procedures and administrative or legal accountability.

If sufficient evidence is found, the matter will be referred to the FIA for investigation and further legal action.

Officials have emphasized that regulatory compliance in the medical-device sector is critical, warning that the unauthorized import, registration or use of medical devices can create serious risks to public health and human lives.